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From: TSS ()
Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA
Date: February 23, 2006 at 8:29 am PST

Posted on Thu, Feb. 23, 2006
Indictments expected in stolen human tissue caseTOM HAYSAssociated PressNEW YORK - When investigators exhumed the body of an 82-year-old woman late last year, they made a shocking discovery: Many of the bones had been removed from the lower half of her body and crudely replaced with plastic plumbing pipe.
Authorities allege the woman and her family were victims of a New Jersey biomedical firm that plotted to secretly carve up cadavers at New York City funeral homes and sell human bone and skin for transplants nationwide.
Brooklyn District Attorney Charles Hynes was expected to announce indictments on Thursday alleging that Michael Mastromarino, owner of Biomedical Tissue Services of Fort Lee, N.J., ran an illicit body parts ring, an official said Wednesday.
Three coconspirators also will be charged, said the official, who spoke on condition of anonymity because the indictments still were sealed. The district attorney's office declined to comment.
Defense attorney Mario Gallucci said in a statement that Mastromarino planned to surrender to authorities Wednesday night. He insisted his client had followed existing rules regulating the harvesting of tissue donated by families at funeral homes.
Mastromarino, a dentist whose license has been suspended, "vehemently denies doing anything illegal or wrong," the lawyer said.
News of the indictments are the latest chapter in a widening scandal involving scores of funeral homes and hundreds of looted bodies, including that of "Masterpiece Theatre" host Alistair Cooke, who died in March 2004.
Federal and local authorities launched an investigation last year after receiving a tip that Mastromarino and others had paid off funeral homes so they could take tissue from the dead without their families' knowledge.
Investigators say some body parts came from elderly people and perhaps victims of infectious diseases, and the paperwork was doctored to say they had been younger and healthier. They say the suspects profited by selling the tissue to companies that turned it into products used for disk replacements, dental implants and a variety of other surgeries done by unsuspecting doctors across the United States and in Canada.
In Cooke's case, investigators claim Biomedical Tissue Services removed his bones without his family's permission before he was cremated. Cooke died of cancer at 95, but documents listed the cause of death as heart attack and lowered his age to 85.
Mastromarino contends he "was not responsible for interacting with the families of the deceased nor in obtaining the documentation needed to harvest the tissue," his lawyer said.
Late last year, the Food and Drug Administration ordered a recall of the potentially tainted products and warned that an untold number of patients could have been exposed to HIV and other diseases during the procedures. It also insisted the risk of infection was minimal.
In one such case, a Long Island woman sued the North Shore-Long Island Jewish Health System after she tested positive for syphilis after undergoing back surgery there. Following the surgery, the hospital informed her that donated human tissue - harvested by Biomedical Tissue Services - used in her surgery could have been tainted. A subsequent test showed that the woman did not have syphilis, and the hospital on Thursday filed a request in state Supreme Court in Mineola for an order to show cause, seeking sanctions against Battisti for "filing frivolous litigation."
The woman, Patricia Battisti of Franklin Square, meanwhile, said she intended to file a new suit against the hospital, alleging emotional damage.
On Feb. 3, the FDA shut Biomedical Tissue Services, saying it had uncovered evidence the firm failed to screen for contaminated tissue. The agency also said it found that death certificates in the company's files were at odds with those on file with the state over the age of the deceased and the causes and times of death.
Allowing the firm to remain open "would present a danger to public health by increasing the risk of communicable disease transmission," said Margaret Glavin, the FDA's associate director of regulatory affairs.


http://www.philly.com/mld/philly/news/13942481.htm


TSS
----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Sunday, February 05, 2006 10:31 AM
Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA


> ##################### Bovine Spongiform Encephalopathy #####################
>
> Subject: FDA Orders Biomedical Tissue Services, Ltd., to Cease Manufacturing
> and to Retain Existing Inventories of ......
> Date: February 5, 2006 at 8:07 am PST
>
> FDA News
>
> FOR IMMEDIATE RELEASE
> P06-17
> February 3, 2006
>
> Media Inquiries:
> Stephen King, 301-827-6242
> Consumer Inquiries:
> 888-INFO-FDA
>
> FDA Orders Biomedical Tissue Services, Ltd., to Cease Manufacturing and to
> Retain Existing Inventories of Human Cells, Tissues and Cellular and
> Tissue-Based Products (HCT/Ps)
>
> Under its comprehensive framework for ensuring the safety of human tissue
> products, the U.S. Food and Drug Administration (FDA) today ordered
> Biomedical Tissue Services, Ltd. (BTS), of Fort Lee, NJ, a human
> tissue-recovery firm, and its CEO and Executive Director of Operations,
> Michael Mastromarino, D.D.S., to immediately cease all manufacturing
> operations. All tissue products initially recovered from human donors by BTS
> were recalled. FDA is carefully monitoring these recalls to account for all
> of the tissue distributed.
>
> "FDA's investigation of BTS revealed serious and widespread deficiencies in
> their manufacturing practices that provide the agency reason to believe that
> allowing the firm to manufacture would present a danger to public health by
> increasing the risk of communicable disease transmission," said Margaret
> O'K. Glavin, FDA's Associate Commissioner for Regulatory Affairs.
>
> "FDA's current regulatory framework for Human Tissue and Cellular and Tissue
> Based Products (HCT/Ps) provides strong measures that the agency can utilize
> to prevent the introduction, transmission, or spread of communicable
> diseases by HCT/Ps, and require firms to screen and test donors for relevant
> communicable disease agents and diseases and to ensure that HCT/Ps are
> processed in a way that prevents communicable disease contamination and
> cross-contamination," added Jesse L. Goodman, MD, MPH, director of FDA's
> Center for Biologics Evaluation and Research.
>
> The FDA order to cease manufacturing and to retain HCT/Ps requires BTS to
> suspend any and all manufacturing steps, including but not limited to the
> recovery and shipment of HCT/Ps. FDA's inspection of BTS uncovered serious
> violations of the regulations governing donor screening and record keeping
> practices, as well as failures to follow their own standard operating
> procedures (SOPs), failure to recover HCT/Ps in a manner that does not cause
> contamination or cross-contamination during recovery, and failure to
> adequately control environmental conditions. Despite records maintaining
> otherwise, the firm had inadequately screened donors for risk factors for,
> or clinical evidence of, relevant communicable disease agents and diseases.
> In addition, FDA found numerous instances where death certificates
> maintained in BTS' files were at variance with the death certificates FDA
> obtained from the state where the death occurred, on important information
> such as cause, place, and time of death, and the identity of the next of
> kin. After initially focusing efforts on assessing the safety of distributed
> tissues and facilitating the appropriate recalls, the Agency has determined
> that these violations, because of their serious nature, constitute a danger
> to health and is taking this unprecedented action.
>
> FDA continues to investigate BTS' activities and to work cooperatively with
> tissue processors and appropriate federal, state and local authorities, and
> will take further actions as needed.
>
> You can view a copy of the BTS Order of Cessation at:
> www.fda.gov/cber/compl/bts013106.htm.
>
> ####
>
> http://www.fda.gov/bbs/topics/news/2006/NEW01309.html
>
> January 31, 2006
>
> CERTIFIED MAIL
> RETURN RECEIPT REQUESTED
>
> Michael Mastromarino, D.D.S.
> CEO & Executive Director of Operations
> Biomedical Tissue Services, Ltd.
> 2125 Center Avenue, Suite 300
> Fort Lee, NJ 07024-5874
>
> Dear Dr. Mastromarino:
>
> The Food and Drug Administration (FDA or the agency) conducted an inspection
> of your establishment, Biomedical Tissue Services, Ltd. (BTS or
> Establishment), at 2125 Center Avenue, Suite 300, Fort Lee, New Jersey
> 07024, which manufactures human cells, tissues, and cellular and
> tissue-based products (HCT/Ps), between October 4 and 27, 2005. At the
> conclusion of the inspection, the FDA investigators issued you a Form
> FDA-483, Inspectional Observations. In addition to the inspection, the
> agency conducted a concurrent investigation of several funeral homes that
> provided you with potential donors of HCT/Ps for recovery. Our review of the
> information and records examined and collected during the inspection and
> investigation reveal that significant violations of Title 21, Code of
> Federal Regulations (21 CFR), Part 1271, issued under the authority of
> Section 361 of the Public Health Service Act (PHS Act) [42 U.S.C. 264],
> exist at BTS. The agency has determined that these deviations, because of
> their serious nature, constitute a danger to health. This Order to Cease
> Manufacturing and to Retain HCT/Ps relates exclusively to conduct occurring
> on or after May 25, 2005, the effective date of these regulations. We note
> that the FDA retains authority to pursue other actions and remedies.
>
> Therefore, pursuant to 21 CFR 1271.440(a)(1) and (3), both you individually,
> and your Establishment, 1) must immediately cease all manufacturing until
> compliance with the regulations in 21 CFR Part 1271 has been achieved, and
> 2) must retain all HCT/Ps recovered on or after May 25, 2005 that are in
> your possession until they are disposed of as agreed by the agency or until
> the safety of the HCT/P is confirmed. Pursuant to 21 CFR 1271.3(e),
> "Manufacture" means, but is not limited to, any or all steps in the
> recovery, processing, storage, labeling, packaging, or distribution of any
> HCT/P, and the screening or testing of the HCT/P donor.
>
> Deficiencies noted include, but are not limited to, the following:
>
> 1. You failed to implement the standard operating procedures (SOP or SOPs)
> that you have established for all steps that you perform in determining
> donor eligibility, as required by 21 CFR 1271.47(a), and you failed to
> review the certificate of death for each donor, a relevant medical record,
> regarding risk factors for, or clinical evidence of, relevant communicable
> disease agents and diseases, as required by 21 CFR 1271.75(a). More
> specifically, your standard operating procedure entitled "Donor
> Identification" requires that, when recovering HCT/Ps at a funeral home, you
> review the death certificate to confirm the eligibility of the donor.
> However, you recovered HCT/Ps from at least eight donors, obtained from ---
> different funeral homes, located in ------ different states, in which you
> failed to review valid death certificates. The documents purporting to be
> the certificates of death for these donors were collected from BTS during
> our inspection, are not authentic death certificates issued by the state,
> and are inaccurate. For example:
>
> 1. You confirmed the eligibility of donor ------------, who donated HCT/Ps
> at a funeral home in ----------. The donor is listed on the BTS version of
> the certificate of death as being 63 years of age, having died of acute
> myocardial infarction due to coronary artery disease, at ----pm
> on ------------, whereas the State of ---------------issued certificate of
> death lists this donor as being 69 years of age, having died of multi-organ
> failure, due to liver dysfunction, which in turn was due to thrombosis,
> at ----pm on ------------------;
>
> 2. You confirmed the eligibility of donor --------------, who donated HCT/Ps
> at a funeral home in ----------------. The donor is listed on the BTS
> version of the certificate of death as being 44 years of age, having died of
> blunt trauma in a motor vehicle accident, at ----am on ----------------,
> whereas the State of -----------------issued certificate of death lists this
> donor as being 48 years of age, having died of congestive cardiac failure
> due to atherosclerotic cardiovascular disease, at ----am
> on ------------------;
>
> 3. You confirmed the eligibility of donor -------------, who donated HCT/Ps
> at a funeral home in ---------------. The donor is listed on the BTS version
> of the certificate of death as being 70 years of age, having died of
> cardio-pulmonary arrest due to acute myocardial infarction, at ---- pm
> on ------------------, whereas the State of ---------------------issued
> certificate of death lists this donor as being 74 years of age, having died
> of complications from the intravenous administration of medication due to a
> radical resection of
> a -----------------------------------------------------------------, at ----
> pm on ---------------------;
>
> 4. You confirmed the eligibility of donor ------------------, who donated
> HCT/Ps at a funeral home in ---------------. The donor is listed on the BTS
> version of the certificate of death as having died of cardio-pulmonary
> arrest due to atherosclerotic heart disease, at ----pm on -----------------,
> whereas the State of -------------issued certificate of death lists this
> donor as having died of cardio-pulmonary asystole due to sepsis and shock,
> at ----pm on --------------;
>
> 5. You confirmed the eligibility of donor ---------------, who donated
> HCT/Ps at a funeral home in ----------------------. The donor is listed on
> the BTS version of the certificate of death as being 45 years of age, having
> died of blunt trauma due to a motor vehicle accident, at ----pm
> on ---------------, whereas the State of ----------------------issued
> certificate of death lists this donor as being 41 years of age, with a cause
> of death which was undetermined pending additional studies, at ----pm
> on -------------------;
>
> 6. You confirmed the eligibility of donor -------------, who donated HCT/Ps
> at a funeral home in -------------. The donor is listed on the BTS version
> of the certificate of death as having died of cardio-pulmonary arrest due to
> acute myocardial infarction, at ----pm on -----------------, whereas the
> State of ------------------issued certificate of death lists this donor as
> dying of probable ventricular fibrillation due to -------------------
> failure, as a consequence of -------------------- disease, at ----am
> on ----------------------;
>
> 7. You confirmed the eligibility of donor -------------, who donated HCT/Ps
> at a funeral home in ------------. The donor is listed on the BTS version of
> the certificate of death as being 58 years of age, having died of acute
> myocardial infarction, at ----am on ----------, whereas the State
> of ---------------------issued certificate of death lists this donor as
> being 50 years of age, having died of diabetes mellitus and hypertension due
> to cardio-vascular disease, at ----pm on ---------------------------; and
>
> 8. You confirmed the eligibility of donor --------------, who donated HCT/Ps
> at a funeral home in ----------------. The donor is listed on the BTS
> version of the certificate of death as being 63 years of age, having died of
> acute myocardial infarction, at ----pm on ------------, whereas the State
> of -------------issued certificate of death lists this donor as being 79
> years of age, having died of pneumonia due to a myocardial infarction,
> at ----pm on -----------------.
>
> 2. You failed to implement the SOPs that you have established for all steps
> that you perform in determining donor eligibility, regarding your assessment
> of risk factors for, or clinical evidence of, relevant communicable disease
> agents and diseases, as required by 21 CFR 1271.47(a). Furthermore, you
> failed to create and maintain accurate records, as required by 21 CFR
> 1271.55(d)(2) and 21 CFR 1271.270(a).
>
> More specifically, your "Documenting the Recovery" SOP requires that, if the
> donor had been admitted to a health care facility immediately prior to
> death, you were to document the date and reason for admission; check the
> appropriate boxes regarding availability of donor history, physical, and
> discharge summary; check the appropriate box regarding surgeries; check the
> appropriate boxes regarding availability of lab results (including blood
> cultures, x-rays, and lung biopsies); and check the appropriate boxes
> regarding documentation of HIV, Hepatitis and Tuberculosis infection.
> However, your Medical Evaluation forms for
> donors -----------------, ---------------, -------------------, ------------
> -, ---------------, and -------------------- (who donated HCT/Ps
> in ---------- different funeral homes located in ---------- different
> states), do not contain any of this information. Instead, you incorrectly
> stated that these donors were "not admitted to a health care facility
> immediately prior to death.," which statements are contradicted by the
> state-issued certificates of death for each of these donors.
>
> 3. You failed to create and maintain accurate records, as required by 21 CFR
> 1271.55(d)(2) and 21 CFR 1271.270(a). More specifically:
>
> 1. The Medical Evaluation forms created and maintained by you for the
> following six donors are inaccurate in that you state that the donors were
> "not admitted to a health care facility immediately prior to death.." In so
> doing, you also failed to adhere to the following SOPs: Documenting the
> Recovery SOP; Quality Assurance Audit of Donor Records SOP; Quality
> Assurance Check-Off Form; and Audit Check List. These six donors donated
> HCT/P at -----different funeral homes, located in -------- different states.
> More specifically:
>
> 1. the State of --------------issued certificate of death for
> donor ----------------- states that at the time of her death she was a
> patient at ------------------- Hospital;
> 2. the State of ------------issued certificate of death for
> donor ------------------ states that at the time of his death he was a
> hospital inpatient at ---------;
> 3. the State of --------------issued certificate of death for
> donor ---------- states that at the time of his death he was a patient
> at --------------------- Hospital;
> 4. the State of ----------------issued certificate of death for
> donor ---------- states that at the time of her death she was a patient
> at ------------- Hospital;
> 5. the State of ---------------------issued certificate of death for
> donor ---------- states that at the time of his death he was a patient
> at -------------- Hospital; and
> 6. the State of ---------------issued certificate of death for
> donor --------------- states that at the time of her death she was a patient
> in the emergency room of ----------------- Hospital.
>
> 2. The records created and maintained by you for donor --------------- are
> inaccurate in that you state in your Certifying Physician Interview form
> that the donor was a 44 year old male who died as a result of a blunt trauma
> to the head region in a motor vehicle accident; your Circumstances of Death
> form states that the donor was a 44 year old male who was involved in a
> motor vehicle accident, sustained blunt trauma, and expired at the scene of
> the accident prior to medical intervention; and your Donor Physical
> Assessment form includes an incorrect schematic of the donor, showing
> fractures to the anterior and posterior portions of the skull, together with
> bruises or contusions to the anterior and posterior portions of the neck.
> These records are contradicted by the State of --------------------issued
> certificate of death, which states that the donor died of natural causes
> (congestive cardiac failure, resulting from atherosclerotic cardiovascular
> disease), at his home, at the age of 48. The only other significant
> condition which is listed as contributing to the death of the donor in the
> State of --------------issued certificate of death
> is -----------------------. In creating and maintaining these inaccurate
> records, you have also failed to adhere to your "Documenting the Recovery"
> SOP, your "Quality Assurance Audit of Donor Records" SOP, your Audit Check
> List, and your Quality Assurance Check-Off form.
>
> 3. The records created and maintained by you for donor ---------------- are
> inaccurate in that you state in your Certifying Physician Interview form
> that the donor was a 45 year old female who suffered blunt trauma in a motor
> vehicle accident, and died at the scene of the accident prior to medical
> intervention; your Circumstances of Death form states that the donor was a
> 45 year old female who was involved in a motor vehicle accident, sustained
> blunt trauma to the head region, and expired prior to medical intervention;
> and your Donor Physical Assessment form includes an incorrect schematic of
> the donor, showing fractures to the anterior and posterior portions of the
> skull, together with bruises or contusions to the anterior and posterior
> portions of the neck. These records are contradicted by the State
> of --------------issued certificate of death, which states that the donor
> died at her home, at the age of 41, was -----, and with an undetermined
> cause of death, pending additional studies. There were no other significant
> conditions listed as possibly contributing to the death of the donor in the
> state-issued certificate of death. In creating and maintaining these
> inaccurate records, you have also failed to adhere to your "Documenting the
> Recovery" SOP, your "Quality Assurance Audit of Donor Records" SOP, your
> Audit Check List, and your Quality Assurance Check-Off form.
>
> 4. The records created and maintained by you for donor ------------- are
> inaccurate and incomplete in that your Certifying Physician Interview form
> for this donor fails to indicate the cause of death; your Circumstances of
> Death form for this donor incorrectly states that the donor was a 70 year
> old female, and fails to indicate the cause of death; your Medical/Social
> History Interview form incorrectly states that the donor never received an
> organ transplant; and your Donor Physical Assessment form for this donor
> fails to show on the schematic that the donor had a surgical procedure to
> her ------------------------ immediately prior to her death, and also fails
> to show that the donor had undergone a ------ transplant. These records are
> contradicted by the State of ------------issued certificate of death, which
> states that the immediate cause of death of this donor was due to
> complications related to the intravenous administration of medication due to
> a --------------------------------------------------------------------------
> ----------------------------. The donor is also listed on the State
> of ----------------issued certificate of death as having undergone a status
> post-cadaver -------- transplant for ------------- disease, and as having
> died at the age of 74. In creating and maintaining these inaccurate records,
> you have also failed to adhere to your "Quality Assurance Audit of Donor
> Records" SOP, your "Documenting the Recovery" SOP, your Audit Check List,
> and your Quality Assurance Check-Off form.
>
> 5. The records created and maintained by you are inaccurate as concerns the
> identity of the funeral home from which donors -------, ----------------,
> and ----------------------were obtained and at which HCT/P recovery
> procedures were performed for these donors. In your Donor Demographics forms
> for these donors you state that their recovery location was a funeral home
> in -----------, -------------, and you also state that the director of the
> funeral home provided you with a positive identification of these three
> donors. However, in an affidavit provided to the agency by the director of
> the funeral home, while he estimates that his funeral homes have provided
> between --- and ---- donors to BTS, they did not provide BTS with these
> three donors. In creating and maintaining these inaccurate records, you have
> also failed to adhere to your "Quality Assurance Audit of Donor Records"
> SOP, your "Documenting the Recovery" SOP, your Audit Check List, and your
> Quality Assurance Check-Off form.
>
> 4. You failed to implement the SOPs you established for donor eligibility
> determinations specifically for documenting and confirming the identity of
> the donors' next of kin, including your Donor Medical Social History
> Interview SOP, your Quality Control Review of Donor Records SOP, your
> Quality Assurance Audit of Donor Records SOP, your Audit Check List, and
> your Quality Assurance Check-Off form, all as required by 21 CFR 1271.47(a),
> and you failed to create and maintain accurate records, as required by 21
> CFR 1271.55(d)(2) and 21 CFR 1271.270(a), in that you have inaccurately and
> incompletely recorded the donors' next of kin information. More
> specifically:
>
> 1. The records created and maintained by you for donor ------------ are
> inaccurate and incomplete in that your information on the donor's spouse
> differs from that found in the State of -------------issued certificate of
> death. More specifically:
>
> 1. while your Consent for Donation of Anatomical Gifts form for this donor
> lists the donor's spouse as the consenting next of kin, the donor's spouse
> is incorrectly listed as another individual, residing at an entirely
> different address than the donor;
> 2. while your Medical/Social History Interview form for this donor lists the
> interviewee as the donor's spouse, the interview form incorrectly identifies
> the donor's spouse and residential address;
> 3. your Circumstances of Death form for this donor also incorrectly
> identifies the spouse; and
> 4. the BTS version of the certificate of death for this donor is incomplete
> in that it does not list any surviving spouse, and does not indicate whether
> the donor was married.
>
> 2. The records created and maintained by you for donor ------------- are
> inaccurate and incomplete in that your information on the donor's spouse
> differs from that found in the State of --------------issued certificate of
> death. More specifically:
>
> 1. while your Consent for Donation of Anatomical Gifts form for this donor
> lists the donor's spouse as the consenting next of kin, the donor's spouse
> is incorrectly listed as another individual, residing at an entirely
> different address than the donor;
> 2. while your Medical/Social History Interview form for this donor lists the
> interviewee as the donor's spouse, the interview form incorrectly identifies
> the donor's spouse and residential address;
> 3. your Circumstances of Death form for this donor also incorrectly
> identifies the spouse; and
> 4. the BTS version of the certificate of death for this donor is incomplete
> in that it does not list any surviving spouse, and does not indicate whether
> the donor was married.
>
> 5. You failed to implement the SOPs you established for donor eligibility
> determinations, as required by 21 CFR 1271.47(a), and to assure the timely
> refrigeration of donors and recovery of HCT/P, as required by 1271.180(a).
> You failed to recover HCT/P in a manner that does not cause contamination or
> cross-contamination during recovery, to adequately control environmental
> conditions, and to provide proper conditions for operations, all as required
> by 21 CFR 1271.145, 21 CFR 1271.195(a)(1), and 21 CFR 1271.215. Furthermore,
> you failed to create and maintain accurate records, as required by 21 CFR
> 1271.55(d)(2) and 21 CFR 1271.270(a).
>
> Your SOPs require that donors be refrigerated within ----- hours and that
> HCT/P excision begin within ----- hours post cardiac asystole. However, you
> did not meet these standards for the following donors:
>
> 1. your Donor Demographics form for donor ------------- states that the
> donor was ".refrigerated within --- hours and tissue excision began
> within ---- hours post cardiac asystole" and that the donor's refrigeration
> time was at ----am on -----------, which, according to the State
> of --------------------issued certificate of death's time of death (----pm
> on ----------------), is more than 33 hours post-cardiac asystole. Also,
> according to your Tissue Recovery Log form for this donor, HCT/P excision of
> the donor began at ----pm on --------, almost 48 hours post-cardiac
> asystole. As a result, your Donor Demographics form is inaccurate; and
>
> 2. your Donor Demographics form for donor ---------------states that the
> donor was ".refrigerated within ----hours and tissue excision began
> within ---- hours post cardiac asystole" and that the donor's refrigeration
> time was at --------------------------------------------, which, according
> to the State
> of -------------------------------------------------------------------------
> ------------------------issued certificate of death
> (---------------------------------------------), is almost 48 hours
> post-cardiac asystole. Also, according to your Tissue Recovery Log form for
> this donor, HCT/P excision of the donor began at ----pm on -------------,
> more than 54 hours post-cardiac asystole. As a result, your Donor
> Demographics form is inaccurate.
>
> 6. You failed to implement SOPs you established to assure that HCT/P
> recovery takes place in a suitable environment, as required by 21 CFR
> 1271.180(a). You failed to recover HCT/Ps in a manner that does not cause
> contamination or cross-contamination during recovery, and you failed to
> adequately control environmental conditions and to provide proper conditions
> for operations, all as required by 21 CFR 1271.145, 21 CFR 1271.195(a)(2),
> and 21 CFR 1271.215. Furthermore, you failed to create and maintain accurate
> records, as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a). Your
> SOP requires that the HCT/P recovery site ensure a maintained and
> controlled, closed airflow system so that there is no direct access to the
> outside of the building. However, you recovered HCT/P from donors ----------
> and ------------ at a funeral home in ------------, ---------- that is not
> equipped with any refrigeration units in which to hold the deceased. The
> embalming room where HCT/P recovery took place was equipped with an exhaust
> fan that delivered air to the adjacent garage/outside. There was no air
> filtration system in the room. Moreover, you recorded in your Nonstandard
> Tissue Recovery Site Assessment form for these donors that the recovery site
> ensured a maintained and controlled, closed airflow system so that there was
> no direct access to the outside of the building.
>
> 7. You failed to implement SOPs you established for donor eligibility
> determinations, specifically to confirm whether an autopsy was performed, as
> required by 21 CFR 1271.47(a). In particular, your Quality Control Review of
> Donor Records SOP requires that "[t]he team leader will assure a physical
> exam was performed and the information documented on the recovery paperwork
> is included in the donor chart." and your Physical Assessment of a Cadaveric
> Donor SOP requires that the team leader physically check the donor in their
> entirety. Furthermore, you failed to create and maintain accurate records,
> as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a). Your Donor
> Demographics forms for donors -------- and ----------------------- state
> that no autopsies had been performed on these donors, and the Donor Physical
> Assessment forms for these donors provide schematics of the donors which
> fail to show that autopsies had been performed. These documents are
> contradicted by the State of ----------------issued certificates of death
> for these donors, which confirm not only that autopsies were performed on
> these two donors, but also that the autopsy findings were available to
> complete the cause of death. The fact that an autopsy had been performed
> should have been obvious to you upon your physical assessment of the donors
> at the time of HCT/P recovery.
>
> The above-identified deficiencies are not intended to be an all-inclusive
> list of violations by you and your Establishment. Nevertheless, they
> indicate serious noncompliance with many of the regulations under 21 CFR
> Part 1271, which are designed to protect against the risks of communicable
> disease transmission. Of particular concern are the serious deficiencies
> involving:
>
> 1/ your failure to create and maintain accurate records;
> 2/ your failure to implement SOPs for all steps in determining donor
> eligibility;
> 3/ your failure to recover HCT/Ps in a manner that does not cause
> contamination or cross-contamination during recovery; and
> 4/ your failure to adequately control environmental conditions.
>
> These deficiencies involve donors from numerous funeral homes located in
> different states. Based on the foregoing, the agency finds that there are
> reasonable grounds to believe that HCT/Ps manufactured by you are violative
> because they were manufactured in contravention of the regulations under 21
> CFR Part 1271 and, therefore, the conditions of manufacture of the HCT/Ps do
> not provide adequate protections against the risks of communicable disease
> transmission. Moreover, these deficiencies, including your failure to create
> and maintain accurate records, are so serious and widespread that FDA finds
> there are reasonable grounds to believe that they present a danger to public
> health.
>
> This letter confirms the telephone conversation on January 31, 2006, in
> which notice was given that, pursuant to 21 CFR 1271.440(a)(3), you
> individually, and your Establishment, 1) must immediately cease all
> manufacturing, as defined in 21 CFR 1271.3(e), until compliance with the
> regulations in 21 CFR Part 1271 has been achieved, and 2) must retain all
> HCT/Ps recovered on or after May 25, 2005 that are in your possession until
> they are disposed of as agreed by the agency or until the safety of the
> HCT/P is confirmed. Instructions were given at that time not to recover or
> ship HCT/Ps. Neither you, nor your Establishment, can resume operations
> without prior written authorization from FDA. Any shipment of HCT/Ps in
> violation of this order constitutes a violation of section 368 of the PHS
> Act [42 U.S.C. § 271], for which criminal penalties may be imposed.
>
> Within five (5) working days from the receipt of this Order to Cease
> Manufacturing, you may request a hearing on the matter in accordance with 21
> CFR Part 16 (copy attached), to Mary A. Malarkey, Director, Office of
> Compliance and Biologics Quality, Center for Biologics Evaluation and
> Research, 1401 Rockville Pike, HFM-600, Rockville, MD 20852 (telephone:
> 301-827-6190). Failure to request a hearing within the specified time period
> constitutes a waiver of the right to a hearing. You may also wish to inform
> yourself with respect to the agency's guidelines regarding electronic media
> coverage of its administrative proceedings, which can be found at 21 CFR
> Part 10, Subpart C.
>
> Sincerely,
>
> ----- signature -----
>
> Jesse L. Goodman, M.D., M.P.H.
> Director
> Center for Biologics Evaluation and Research
>
> Effective Date: 31 January Time: 11:25 AM Eastern
>
> Updated February 1, 2006
>
>
> http://www.fda.gov/cber/compl/bts013106.htm
>
>
> TSS
>
> -----Original Message-----
> From: Terry S. Singeltary Sr. [mailto:flounder9@VERIZON.NET]
> Sent: Wednesday, January 25, 2006 9:09 AM
> To: BSE-L@aegee.org
> Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs
> IN THE USA
>
>
> ##################### Bovine Spongiform Encephalopathy #####################
>
> TSS
> Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND CJD
> Wed Jan 25, 2006 09:05
> 71.248.131.156
>
> Body parts scandal expected to spawn bevy of lawsuits
> Officials say hundreds of bodies were looted in funeral homes in New York
> area
>
> By TOM HAYS
> Associated Press
>
> NEW YORK - Patricia Battisti had thought her back surgery in early 2005 was
> routine. A letter from her hospital nearly a year later made it clear she
> was wrong.
>
> Battisti was informed that the cadaver bone that was implanted in her back
> may have been infected with various viruses - the result of what
> investigators say was a large-scale scheme in which corpses were cut up and
> body parts illegally sold.
>
> The Long Island woman now claims she contracted syphilis from the bone and
> plans to sue. The hospital adamantly denies the allegation. But the case may
> be an early warning that the gruesome body parts scandal is going to lead to
> a lot of lawsuits.
>
> "I just want answers," said Battisti, 41, a single mother of four. "I had
> the operation to feel better, not get sick."
>
> Battisti joins a burgeoning list of potential victims.
>
> Authorities believe two men paid off funeral homes so they could take bone
> and skin from the dead without their families' knowledge. Worse, some body
> parts came from elderly people and perhaps victims of infectious diseases,
> and the paperwork was doctored to say they had been younger and healthier,
> investigators say.
>
> The Brooklyn district attorney's office has opened a criminal case focusing
> on scores of funeral homes in the New York City area and hundreds of looted
> bodies, including that of Masterpiece Theatre host Alistair Cooke. No
> arrests have been made.
>
> At the same time, the Food and Drug Administration is trying to trace the
> tissue, which was sold to medical facilities across the country and in
> Canada.
>
> Both the FDA and hospital officials, while suggesting certain patients
> should get tested for viruses as a precaution, insisted the risk of becoming
> ill from tainted tissue is minuscule.
>
> But some of those patients are not comforted, said Battisti's attorney,
> Jeffrey Lisabeth.
>
> "It really freaks them out," he said.
>
> Also disturbed are families who recently learned of evidence that their dead
> relatives were secretly carved up before being buried or cremated.
>
> A lawsuit filed in Brooklyn accuses a now-defunct New Jersey tissue bank,
> Biomedical Tissue Services, of stealing parts from a 43-year-old woman who
> died of ovarian cancer in 2003. The business allegedly forged a signature on
> a consent form, and listed the cause of death as head trauma.
>
> Authorities also found paperwork indicating Cooke's bones had been removed
> by the tissue bank before he was cremated. Cooke died of cancer last year at
> 95, but authorities say documents listed the cause of death as heart attack
> and lowered his age to 85.
>
> The operators of the tissue bank have denied wrongdoing.
>
> Battisti's ordeal began in December, when North Shore-Long Island Jewish
> Health System warned her and 41 other patients that they were at risk for
> HIV, hepatitis B and C and syphilis. The letters explained that tissue used
> for surgical repairs came from body parts that were removed without
> permission or medical safeguards.
>
> Doctors implanted bone in Battisti's back to relieve pain from a car
> accident injury. Her lawyer said a recent blood test indicated she had been
> exposed to syphilis; she is awaiting the results of further tests.
>
> The hospital's attorney, Anthony Sola, argued the tissue banks were
> responsible for screening and sterilizing their products. He also claimed
> anyone getting syphilis from a bone graft would be "a medical first."
>
> http://chron.com/disp/story.mpl/nation/3610246.html
>
>
> SEE THREAD;
>
> http://disc.server.com/discussion.cgi?disc=167318;article=2587;title=CJD%20W
> ATCH;pagemark=20
>
>
> Cadaver corneal transplants -- without family permission
>
> Houston, Texas channel 11 news 28 Nov 99
> Reported by Terry S. Singeltary Sr. son of CJD victim
>
> http://mad-cow.org/~tom/dec99_news.html#bbb
>
>
> TSS
>
> ----- Original Message -----
> From: "Terry S. Singeltary Sr."
> To:
> Sent: Wednesday, January 18, 2006 3:54 PM
> Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN
> THE USA
>
>
> > ##################### Bovine Spongiform Encephalopathy
> #####################
> >
> > ENFORCE -- January 18, 2006
> >
> > 06-03
> >
> >
> >
> > PRODUCT
> > Human Tissue for Transplantation, Recall # B-0322-6
> > a) Alloquent CC Allograft (8, 9 & 10 mm);
> > b) Achilles Tendon;
> > c) Cancellous Bone 4-10 mm (15 & 30 cc);
> > d) Patella Tendon-Hemi;
> > e) Iliac Crest Wedge (14-17mm, 11-13mm,
> > <10mm, and 18+mm);
> > f) Tibialis Tendon
> > CODE
> > a) Code: BS30-4008, BS30-4009, BS30-4010;
> > b) Code: LATM;
> > c) Code: LCISM & LCIPM;
> > d) Code: LTTM;
> > e) Code: LIWXLM, LIWLM, LIWMM, LIWSM;
> > f) Code: LTTM
> > RECALLING FIRM/MANUFACTURER
> > Recalling Firm: Lost Mountain Tissue Bank, Kennesaw, GA, by letters dated
> > October 12, and October 21, 2005.
> > Manufacturer: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firm
> initiated
> > recall is ongoing.
> > REASON
> > Human tissues, procured from donors without adequate donor eligibility
> > determinations, were distributed.
> > VOLUME OF PRODUCT IN COMMERCE
> > 283 tissues
> > DISTRIBUTION
> > Nationwide and Turkey
> >
> > _______________________________
> > PRODUCT
> > PUROS Allograft Bone;
> > Suspend Tutoplast Processed Fascia Lata,
> > Recall # B-0375-6
> > CODE
> > a) U00000000045293 U00000000045294 U00000000045295 U00000000045296
> > U00000000045297 U00000000045298 U00000000045299 U00000000045300
> > U00000000045301 U00000000045302 U00000000045303 U00000000045368
> > U00000000045369 U00000000045370 U00000000045371 U00000000045372
> > U00000000045373 U00000000045374 U00000000045375 U00000000045425
> > U00000000045426 U00000000045427 U00000000045428 U00000000045429
> > U00000000045430 U00000000045532 U00000000045533 U00000000045534
> > U00000000045535 U00000000045536 U00000000045537 U00000000045618
> > U00000000045619 U00000000045620 U00000000045621 U00000000045622
> > U00000000045623 U00000000045624 U00000000045625 U00000000045626
> > U00000000045627 U00000000045628 U00000000045629 U00000000045630
> > U00000000045680 U00000000045681 U00000000045682 U00000000045683
> > U00000000045684 U00000000045685 U00000000045686 U00000000045821
> > U00000000045822 U00000000045823 U00000000045846 U00000000045847
> > U00000000045848 U00000000045849 U00000000045850 U00000000045851
> > U00000000045852 U00000000045853 U00000000045854 U00000000045855
> > U00000000045895 U00000000045896 U00000000045897 U00000000045898
> > U00000000045899 U00000000045900 U00000000045901 U00000000045902
> > U00000000045903 U00000000045904 U00000000045905 U00000000045931
> > U00000000045932 U00000000045933 U00000000045934 U00000000045935
> > U00000000045936 U00000000045937 U00000000045938 U00000000045939
> > U00000000045945 U00000000045946 U00000000045947 U00000000045948
> > U00000000045949 U00000000045950 U00000000045951 U00000000045952
> > U00000000045962 U00000000045963 U00000000045964 U00000000045965
> > U00000000045966 U00000000045967 U00000000045968 U00000000014542
> > U00000000014210 U00000000014211 U00000000014212 U00000000014213
> > U00000000014214 U00000000014215 U00000000014216 U00000000014217
> > U00000000014218 U00000000014219 U00000000014220 U00000000014221
> > U00000000014222 U00000000014223 U00000000014224 U00000000014225
> > U00000000014226 U00000000014227 U00000000014228 U00000000014229
> > U00000000014230 U00000000014231 U00000000014232 U00000000014233
> > U00000000014234 U00000000014235 U00000000014236 U00000000014237
> > U00000000014238 U00000000014239 U00000000014240 U00000000014241
> > U00000000014242 U00000000014243 U00000000014294 U00000000014295
> > U00000000014296 U00000000014297 U00000000014298 U00000000014299
> > U00000000014300 U00000000014301 U00000000014302 U00000000014303
> > U00000000014304 U00000000014305 U00000000014306 U00000000014307
> > U00000000014308 U00000000014309 U00000000014310 U00000000014311
> > U00000000014312 U00000000014313 U00000000014314 U00000000014315
> > U00000000014316 U00000000014317 U00000000014318 U00000000014319
> > U00000000014320 U00000000014321 U00000000014322 U00000000014323
> > U00000000014324 U00000000014325 U00000000014326 U00000000014327
> > U00000000014328 U00000000014329 U00000000014330 U00000000014331
> > U00000000014332 U00000000014333 U00000000014334 U00000000014335
> > U00000000014336 U00000000014337 U00000000014338 U00000000014339
> > U00000000014340 U00000000014341 U00000000014342 U00000000014343
> > U00000000014344 U00000000014345 U00000000014346 U00000000014347
> > U00000000014348 U00000000014349 U00000000014350 U00000000014351
> > U00000000014352 U00000000014354 U00000000014355 U00000000014356
> > U00000000014357 U00000000014358 U00000000014359 U00000000014360
> > U00000000014361 U00000000014362 U00000000014363 U00000000014364
> > U00000000014365 U00000000014366 U00000000014367 U00000000014368
> > U00000000014369 U00000000014370 U00000000014371 U00000000014372
> > U00000000014373 U00000000014374 U00000000014375 U00000000014376
> > U00000000014377 U00000000014378 U00000000014379 U00000000014380
> > U00000000014381 U00000000014382 U00000000014383 U00000000014384
> > U00000000014385 U00000000014386 U00000000014387 U00000000014388
> > U00000000014389 U00000000014390 U00000000014391 U00000000014392
> > U00000000014393 U00000000014394 U00000000014395 U00000000014396
> > U00000000014397 U00000000014398 U00000000014399 U00000000014400
> > U00000000014401 U00000000014402 U00000000014403 U00000000014404
> > U00000000014405 U00000000014406 U00000000014407 U00000000014408
> > U00000000014409 U00000000014410 U00000000014411 U00000000014412
> > U00000000014413 U00000000014414 U00000000014415 U00000000014416
> > U00000000014417 U00000000014418 U00000000014419 U00000000014420
> > U00000000014421 U00000000014422 U00000000014423 U00000000014424
> > U00000000014425 U00000000014426 U00000000014427 U00000000014428
> > U00000000014429 U00000000014430 U00000000014431 U00000000014432
> > U00000000014433 U00000000014434 U00000000014435 U00000000014436
> > U00000000014437 U00000000014438 U00000000014439 U00000000014440
> > U00000000014441 U00000000014442 U00000000014443 U00000000014444
> > U00000000014445 U00000000014446 U00000000014447 U00000000014448
> > U00000000014449 U00000000014450 U00000000014451 U00000000014452
> > U00000000014453 U00000000014454 U00000000014460 U00000000014461
> > U00000000014462 U00000000014463 U00000000014464 U00000000014465
> > U00000000014466 U00000000014467 U00000000014468 U00000000014469
> > U00000000014470 U00000000014471 U00000000014472 U00000000014473
> > U00000000014474 U00000000014475 U00000000014477 U00000000014478
> > U00000000014479 U00000000014480 U00000000014481 U00000000014482
> > U00000000014483 U00000000014484 U00000000014485 U00000000014486
> > U00000000014487 U00000000014488 U00000000014489 U00000000014490
> > U00000000014491 U00000000014492 U00000000014493 U00000000014494
> > U00000000014495 U00000000014496 U00000000014497 U00000000014498
> > U00000000014499 U00000000014500 U00000000014501 U00000000014502
> > U00000000014503 U00000000014504 U00000000014505 U00000000014506
> > U00000000014507 U00000000014508 U00000000014509 U00000000014510
> > U00000000014511 U00000000014512 U00000000014513 U00000000014514
> > U00000000014515 U00000000014516 U00000000014517 U00000000014518
> > U00000000014519 U00000000014520 U00000000014521 U00000000014522
> > U00000000014523 U00000000014524 U00000000014525 U00000000014526
> > U00000000014527 U00000000014528 U00000000014529 U00000000014530
> > U00000000014531 U00000000014532 U00000000014533 U00000000014534
> > U00000000014535 U00000000014536 U00000000014537 U00000000014538
> > U00000000014539 U00000000014540 U00000000014541 U00000000014543
> > U00000000014544 U00000000014545 U00000000014546 U00000000014547
> > U00000000018019 U00000000042694 U00000000042695 U00000000042696
> > U00000000042697 U00000000042698 U00000000042699 U00000000042700
> > U00000000042701 U00000000042703 U00000000042704 U00000000042705
> > U00000000042706 U00000000042707 U00000000042708 U00000000042709
> > U00000000042710 U00000000042711 U00000000042712 U00000000042713
> > U00000000042714 U00000000042715 U00000000042716 U00000000042717
> > U00000000042718 U00000000042719 U00000000042720 U00000000042721
> > U00000000042722 U00000000042723 U00000000042724 U00000000042725
> > U00000000042726 U00000000042834 U00000000042835 U00000000042836
> > U00000000042838 U00000000042839 U00000000042840 U00000000042841
> > U00000000042842 U00000000042843 U00000000042844 U00000000042845
> > U00000000042893 U00000000042894 U00000000042895 U00000000042896
> > U00000000042897 U00000000042898 U00000000042899 U00000000042900
> > U00000000042901 U00000000042902 U00000000042903 U00000000042904
> > U00000000042905 U00000000042906 U00000000042907 U00000000042908
> > U00000000042909 U00000000042910 U00000000042911 U00000000042912
> > U00000000042913 U00000000042914 U00000000042915 U00000000042916
> > U00000000042917 U00000000042918 U00000000042919 U00000000042920
> > U00000000042954 U00000000042955 U00000000042956 U00000000042957
> > U00000000042958 U00000000042959 U00000000042960 U00000000042961
> > U00000000042962 U00000000042963 U00000000042964 U00000000042965
> > U00000000042966 U00000000042967 U00000000042968 U00000000042969
> > U00000000042970 U00000000042971 U00000000042972 U00000000042973
> > U00000000042974 U00000000042975 U00000000042976 U00000000042977
> > U00000000042978 U00000000042979 U00000000042980 U00000000042981
> > U00000000042982 U00000000042983 U00000000042984 U00000000042985
> > U00000000042986 U00000000042987 U00000000042988 U00000000042989
> > U00000000042990 U00000000042991 U00000000042992 U00000000043018
> > U00000000043019 U00000000043020 U00000000043021 U00000000043022
> > U00000000043023 U00000000043024 U00000000043025 U00000000043026
> > U00000000043027 U00000000043028 U00000000043029 U00000000043030
> > U00000000043031 U00000000043032 U00000000043033 U00000000043034
> > U00000000043035 U00000000043036 U00000000043037 U00000000043038
> > U00000000043039 U00000000043040 U00000000043041 U00000000043042
> > U00000000043043 U00000000043044 U00000000043045 U00000000043046
> > U00000000043047 U00000000043048 U00000000043049 U00000000043050
> > U00000000043145 U00000000043146 U00000000043147 U00000000043148
> > U00000000043149 U00000000043150 U00000000043151 U00000000043152
> > U00000000043153 U00000000043154 U00000000043155 U00000000043156
> > U00000000043157 U00000000043158 U00000000043159 U00000000043160
> > U00000000043161 U00000000043162 U00000000043163 U00000000043164
> > U00000000043165 U00000000043166 U00000000043167 U00000000043168
> > U00000000043169 U00000000043170 U00000000043171 U00000000043210
> > U00000000043211 U00000000043212 U00000000043213 U00000000043214
> > U00000000043215 U00000000043216 U00000000043217 U00000000043218
> > U00000000043219 U00000000043220 U00000000043221 U00000000043222
> > U00000000043223 U00000000043224 U00000000043225 U00000000043226
> > U00000000043227 U00000000043228 U00000000043229 U00000000043230
> > U00000000043231 U00000000043232 U00000000043233 U00000000043234
> > U00000000043235 U00000000043236 U00000000043237 U00000000043238
> > U00000000043239 U00000000043240 U00000000043241 U00000000043242
> > U00000000043243 U00000000043268 U00000000043269 U00000000043270
> > U00000000043271 U00000000043272 U00000000043273 U00000000043274
> > U00000000043275 U00000000043276 U00000000043277 U00000000043278
> > U00000000043279 U00000000043280 U00000000043281 U00000000043282
> > U00000000043283 U00000000043284 U00000000043285 U00000000043286
> > U00000000043287 U00000000043288 U00000000043289 U00000000043290
> > U00000000043307 U00000000043308 U00000000043309 U00000000043310
> > U00000000043311 U00000000043312 U00000000043313 U00000000043314
> > U00000000043315 U00000000043316 U00000000043317 U00000000043318
> > U00000000043319 U00000000043320 U00000000043321 U00000000043322
> > U00000000043323 U00000000043324 U00000000043325 U00000000043326
> > U00000000043327 U00000000043328 U00000000043329 U00000000043330
> > U00000000043331 U00000000043332 U00000000043333 U00000000043334
> > U00000000043335 U00000000043336 U00000000043337 U00000000043338
> > U00000000043339 U00000000043342 U00000000043343 U00000000043344
> > U00000000043345 U00000000043346 U00000000043347 U00000000043348
> > U00000000043349 U00000000043350 U00000000043351 U00000000043352
> > U00000000043353 U00000000043354 U00000000043355 U00000000043356
> > U00000000043357 U00000000043358 U00000000043359 U00000000043360
> > U00000000043361 U00000000043362 U00000000043363 U00000000043364
> > U00000000043365 U00000000043366 U00000000043367 U00000000043368
> > U00000000043369 U00000000043370 U00000000043371 U00000000043372
> > U00000000043386 U00000000043387 U00000000043388 U00000000043389
> > U00000000043390 U00000000043391 U00000000043392 U00000000043393
> > U00000000043394 U00000000043395 U00000000043396 U00000000043397
> > U00000000043398 U00000000043399 U00000000043400 U00000000043401
> > U00000000043402 U00000000043403 U00000000043452 U00000000043453
> > U00000000043454 U00000000043455 U00000000043456 U00000000043457
> > U00000000043458 U00000000043459 U00000000043460 U00000000043461
> > U00000000043462 U00000000043463 U00000000043464 U00000000043465
> > U00000000043466 U00000000043467 U00000000043468 U00000000043469
> > U00000000043490 U00000000043491 U00000000043492 U00000000043493
> > U00000000043494 U00000000043495 U00000000043496 U00000000043497
> > U00000000043498 U00000000043499 U00000000043500 U00000000043501
> > U00000000043502 U00000000043503 U00000000043504 U00000000043505
> > U00000000043506 U00000000043507 U00000000043508 U00000000043509
> > U00000000043510 U00000000043582 U00000000043583 U00000000043584
> > U00000000043585 U00000000043586 U00000000043587 U00000000043588
> > U00000000043589 U00000000043590 U00000000043591 U00000000043592
> > U00000000043593 U00000000043594 U00000000043595 U00000000043596
> > U00000000043597 U00000000043598 U00000000043599 U00000000043600
> > U00000000043601 U00000000043602 U00000000043603 U00000000043604
> > U00000000043605 U00000000043606 U00000000043607 U00000000043608
> > U00000000043609 U00000000043610 U00000000043611 U00000000043612
> > U00000000043613 U00000000043614 U00000000043615 U00000000043616
> > U00000000043617 U00000000043618 U00000000043619 U00000000043620
> > U00000000043621 U00000000043622 U00000000043623 U00000000043653
> > U00000000043654 U00000000043655 U00000000043656 U00000000043657
> > U00000000043658 U00000000043659 U00000000043660 U00000000043661
> > U00000000043662 U00000000043663 U00000000043664 U00000000043665
> > U00000000043666 U00000000043667 U00000000043668 U00000000043669
> > U00000000043670 U00000000043671 U00000000043672 U00000000043673
> > U00000000043674 U00000000043675 U00000000043676 U00000000043677
> > U00000000043678 U00000000043679 U00000000043680 U00000000043681
> > U00000000043682 U00000000043683 U00000000043684 U00000000043685
> > U00000000043686 U00000000043731 U00000000043732 U00000000043733
> > U00000000043734 U00000000043735 U00000000043736 U00000000043737
> > U00000000043738 U00000000043739 U00000000043740 U00000000043741
> > U00000000043742 U00000000043743 U00000000043744 U00000000043745
> > U00000000043746 U00000000043747 U00000000043748 U00000000043749
> > U00000000043750 U00000000043751 U00000000043752 U00000000043753
> > U00000000043754 U00000000043755 U00000000043756 U00000000043757
> > U00000000043758 U00000000043759 U00000000043760 U00000000043761
> > U00000000043762 U00000000043763 U00000000043764 U00000000043765
> > U00000000043766 U00000000043767 U00000000043768 U00000000043769
> > U00000000043770 U00000000043771 U00000000043782 U00000000043783
> > U00000000043784 U00000000043785 U00000000043786 U00000000043787
> > U00000000043788 U00000000043789 U00000000043790 U00000000043791
> > U00000000043792 U00000000043793 U00000000043794 U00000000043795
> > U00000000043796 U00000000043797 U00000000043798 U00000000043799
> > U00000000043800 U00000000043801 U00000000043802 U00000000043803
> > U00000000043804 U00000000043805 U00000000043806 U00000000043807
> > U00000000043808 U00000000043809 U00000000043810 U00000000043811
> > U00000000043812 U00000000043813 U00000000043834 U00000000043835
> > U00000000043836 U00000000043837 U00000000043838 U00000000043839
> > U00000000043840 U00000000043841 U00000000043842 U00000000043843
> > U00000000043844 U00000000043845 U00000000043846 U00000000043847
> > U00000000043848 U00000000043849 U00000000043850 U00000000043851
> > U00000000043852 U00000000043853 U00000000043854 U00000000043855
> > U00000000043856 U00000000043857 U00000000043858 U00000000043859
> > U00000000043860 U00000000043861 U00000000043862 U00000000043863
> > U00000000043864 U00000000043865 U00000000043866 U00000000043867
> > U00000000043868 U00000000043869 U00000000043870 U00000000043871
> > U00000000043872 U00000000043873 U00000000043874 U00000000043876
> > U00000000043877 U00000000043878 U00000000043894 U00000000043895
> > U00000000043896 U00000000043897 U00000000043898 U00000000043899
> > U00000000043900 U00000000043901 U00000000043902 U00000000043903
> > U00000000043904 U00000000043905 U00000000043906 U00000000043907
> > U00000000043908 U00000000043909 U00000000043910 U00000000043911
> > U00000000043920 U00000000043921 U00000000043922 U00000000043923
> > U00000000043924 U00000000043925 U00000000043926 U00000000043927
> > U00000000043928 U00000000043929 U00000000043930 U00000000043931
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> > U00000000028662 U00000000028663 U00000000028664 U00000000028665
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> > U00000000044028 U00000000044029 U00000000044030 U00000000044031
> > U00000000044032 U00000000044033 U00000000044034 U00000000044035
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> > U00000000045283 U00000000045284 U00000000045285 U00000000045286
> > U00000000045287 U00000000045288 U00000000045289 U00000000045290
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> > U00000000045364 U00000000045365 U00000000045366 U00000000045367
> > U00000000045856 U00000000045857 U00000000045858 U00000000045859
> > U00000000045860 U00000000045861 U00000000045862 U00000000045863
> > U00000000045864 U00000000045865 U00000000045866 U00000000045867
> > U00000000045868 U00000000045869 U00000000045906 U00000000045907
> > U00000000045908 U00000000045909 U00000000045910 U00000000045911
> > U00000000045912 U00000000045913 U00000000045914 U00000000045915
> > U00000000045916 U00000000045917 U00000000045918 U00000000045919
> > U00000000045920 U00000000045921 U00000000045922 U00000000045940
> > U00000000045941 U00000000045942 U00000000045943 U00000000045944
> > U00000000045953 U00000000045954 U00000000045955 U00000000045956
> > U00000000045957 U00000000045958 U00000000045959 U00000000045960
> > U00000000045961 U00000000045969 U00000000045970 U00000000045971
> > U00000000045972 U00000000045973 U00000000045974 U00000000045975
> > U00000000045976 U00000000045977 U00000000045978 U00000000045979
> > U00000000045980 U00000000045981 U00000000045982 U00000000045983
> > U00000000045984 U00000000046043 U00000000046044 U00000000046051
> > U00000000046052 U00000000046053 U00000000046054 U00000000046055
> > U00000000046056 U00000000046057 U00000000083301 U00000000083302
> > U00000000083310 U00000000083313 U00000000083317 U00000000083324
> > U00000000083325 U00000000083326 U00000000083327 U00000000083331
> > U00000000083336 U00000000083337 U00000000083338 U00000000083339
> > U00000000083296 U00000000083300 U00000000083303 U00000000083304
> > U00000000083305 U00000000083306 U00000000083307 U00000000083308
> > U00000000083309 U00000000083311 U00000000083312 U00000000083314
> > U00000000083315 U00000000083316 U00000000083318 U00000000083319
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> > U00000000083328 U00000000083329 U00000000083330 U00000000083332
> > U00000000083333 U00000000083334 U00000000083335 U00000000083297;
> > b) BM03L11421A012031504 BM03L11821A012031504 BM04A11421A012041204
> > BM03K10421A017031504 BM03K10421B017031504 BM03K10421C017031504
> > BM03L11221A017020904 BM03L11421A017031504 BM03L11421B017031504
> > BM03L12121A017031504 BM03L12221A017031504 BM04B10421A017051704
> > BM03K10421A018031504 BM03K10421B018031504 BM03K11021A018031504
> > BM03K11021B018031504 BM03K11021C018031504 BM03K11021D018031504
> > BM03L10421A018020904 BM03L10421B018020904 BM03L11621A018031504
> > BM03L11621B018031504 BM03L12121A018031504 BM03L12221A018031504
> > BM04A11221A018041204 BM04A11321A018041204 BM04B10421A018051704
> > BM03L11521A023020904 BM03L11521B023020904 BM03L11521D023020904
> > BM03L11821A024031504 BM03L12321A024031504 BM04A11221A024041204
> > BM03K10421A045031504 BM03K12121A045020904 BM03L10421A045020904
> > BM03L10621A045020904 BM03L11621A045031504 BM03L11621B045031504
> > BM03L12121A045031504 BM03J11421A048011904 BM03J11421B048011904
> > BM03K12121A048020904 BM03L10621A048020904 BM03L10621B048020904
> > BM03L11221A048020904 BM03L11521A048020904 BM03L11521B048020904
> >
> > RECALLING FIRM/MANUFACTURER
> >
> > Recalling Firm: Tutogen Medical, Inc., Alachua, FL, by telephone,
> facsimile
> > and letter on October 14, 2005 and by letter dated October 24, 2005.
> > Responsible Firm: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firm
> > initiated recall is ongoing.
> >
> > REASON
> >
> > Human Tissues, procured from donors without adequate donor eligibility
> > determinations, were distributed.
> > VOLUME OF PRODUCT IN COMMERCE
> > a) 5,676 allografts;
> > b) 48 allografts
> > DISTRIBUTION
> > Nationwide, and Canada
> >
> >
> > http://www.fda.gov/bbs/topics/enforce/2006/ENF00935.html
> >
> >SNIP.......END......TSS
>
> #################### https://lists.aegee.org/bse-l.html ####################
>

Cadaver corneal transplants -- without family permission
Houston, Texas channel 11 news 28 Nov 99
Reported by Terry S. Singeltary Sr.son of CJD victim


http://www.mad-cow.org/~tom/dec99_news.html#bbb

http://www.rense.com/general62/don.htm

TSS




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