From: TSS (216-119-136-171.ipset16.wt.net)
Subject: Re: CJD/TSEs/MADCOW BLOOD -- PRICE OF POKER GOES UP (they have gambled too long)
Date: December 17, 2003 at 2:26 pm PST
In Reply to: CJD/TSEs/MADCOW BLOOD -- PRICE OF POKER GOES UP (they have gambled too long) posted by TSS on December 17, 2003 at 1:29 pm:
*
FDA
Enforcement Report
*
* December 10 2003
PRODUCT
Source Plasma. Recall # B-0343-4.
CODE
Unit numbers 69292460, 69289514, 69279386, 69275999, 69271342, 69263231, 69261695, 69254116, 69252006, 69246098, 69244131, 69239182, 69236723, 69231261, 69211720, 69203664, 69197703, 69195143, 69189326, 69186837, 69180903, and 69178726.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Evansville, IN, by facsimile on September 19, 2002. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
CA. _______________________________
PRODUCT
Source Plasma. Recall # B-0345-4.
CODE
Unit numbers 0181090015, 0181089703, 0181089401, 0181089172, 0181088815, 0181088543, 0181088321, 0181088052, 0181087656, 0181087416, 0181087133, 0181086834, 0181086584, 0181085724, 0181085047, 0181084848, 0181084386, 0181084056, and 0181083713.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Columbus, OH, by facsimile on June 2, 2003. Firm initiated recall is complete.
REASON
Problem: Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Whole Blood. Recall # B-0346-4.
CODE
Unit KC23347.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Reading, PA, by telephone on October 18, 2000. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had not completed a CJD increased risk question, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0362-4.
CODE
Unit numbers 0590270897, 0590270641, 0590270384, 0590270107, 0590270002, and 0590269782.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Allentown, PA, by facsimile on December 19, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0371-4.
CODE
Unit numbers: 0530328359, 0530327758.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lexington, KY, by facsimile dated December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not respond to the questions regarding risk factors for variant Creutzfeldt-Jakob (vCJD) disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC. _______________________________
====================================
* RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II - CJD — TSS, Sun Dec 7 11:10
-------- Original Message --------
Subject: RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II December 3, 2003 (vCJD only recalls?)
Date: Sun, 07 Dec 2003 11:05:45 -0600
From: "Terry S. Singeltary Sr."
To: BSE-L
CC: CJDVOICE , BLOODCJD
FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration, Department of Health and Human Services. It contains
information on actions taken in connection with agency Regulatory
activities.
------------------------------------------------------------------------
December 3, 2003
03-49
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________________
PRODUCT
Source Plasma. Recall # B-0289-4.
CODE
Units 0820847522, 0820846792, and 0820846441.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 12, 2003.
Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions
regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0322-4.
CODE
Unit numbers 0820847552, 0820847180, 0820846460, and 0820846208.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 12, 2003.
Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening
did not include questioning regarding risk factors for new variant
Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0323-4.
CODE
Unit numbers 0820847539, 0820846868, and 0820846419.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 12 and 27,
2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening
did not include questioning regarding risk factors for new variant
Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0328-4.
CODE
Units 0410922872, 0410922682, and 0410922144.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Oak Park, MI, by facsimile on February 21, 2003.
Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions
regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0329-4.
CODE
Units 0410923479, and 0410922710.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Oak Park, MI, by facsimile on February 21, 2003.
Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions
regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0330-4.
CODE
Units 0820847456, 0820846543 and 0820846066.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 12, 2003.
Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions
regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0331-4.
CODE
Units 0820847685 and 0820846107.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 13, and
February 25, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions
regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0332-4.
CODE
Units 69239311, 69235467, 69225451, 69204623, 69198069, 69193477, and
69185649..
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Evansville, IN, by facsimile on August 8, 2002.
Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions
regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0333-4.
CODE
Units 0820847492, 0820846844 and 0820846429.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 12 and
February 25, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions
regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0334-4.
CODE
Units 0820847398, 0820846635 and 0820845994.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 18, 2003.
Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions
regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0335-4.
CODE
Units 0820846185 and 0820946623.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 18, 2003.
Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions
regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0336-4.
CODE
Units 0820847690, 0820847353, 0820846586, and 0820846296.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 14, 2003.
Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions
regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0337-4.
CODE
Unit number: 02GMIE7353.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Walker, MI, by facsimile dated November 6,
2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening
did not include questions regarding risk factors for Creutzfeldt-Jakob
disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
snip...
PRODUCT
Source Plasma. Recall # B-0342-4.
CODE
Unit numbers 0410909205, 0410908973, 0410905035, and 0410903438.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Oak Park, MI, by facsimile on December 2, 2002.
Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of
residing in an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC.
snip...
END OF ENFORCEMENT REPORT FOR DECEMBER 3, 2003
###
http://www.fda.gov/bbs/topics/enforce/2003/ENF00824.html
http://disc.server.com/discussion.cgi?disc=167318;article=1064;title=CJD%20WATCH
TSS
