I'm just waiting to die

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From: TSS (wt-d6-190.wt.net)
Subject: I'm just waiting to die
Date: December 17, 2004 at 8:51 am PST

-------- Original Message --------
Subject: I'm just waiting to die
Date: Fri, 17 Dec 2004 10:39:55 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE

##################### Bovine Spongiform Encephalopathy #####################

I'm just waiting to die

Dec 17 2004

Madeleine Brindley, Western Mail

Haemophiliacs need blood products to survive. But how do you reconcile
the fact that the very substance you must take every day to save your
life will also be responsible for the end of your life?In the past 20
years more than three-quarters of Britain's haemophiliacs who were given
HIV-infected blood have died and those who are still clinging on to life
have just been told they have probably been exposed to the human form of
mad cow disease.Health Editor Madeleine Brindley reports

FOR the past decade at least, Gareth Lewis has been waiting to die. He
has said goodbye to his two teenage daughters on several occasions and
is realistic of his life chances.

Outwardly, at least, he is determined not to let his various terminal
illnesses beat him - he tells me, a voice on the phone, that he has come
this far and is determined not to surrender now.

But ever since he was told he had just two years to live, the
father-of-two has been fulfilling all his lifelong dreams, in case he
doesn't get the chance in the future.

Gareth, a leading voice in the campaign for a public inquiry into one of
the most horrific but little-known health scandals of modern time, has
seen too many of his fellow haemophiliacs succumb to some of the most
serious diseases known to man to still wear rose-tinted glasses about
his long-term future.

He is only 46 but has been to 97 funerals of haemophiliacs who have died
of Aids - the result of taking the very blood products they depend on to
maintain a normal day-to-day life.

"This is what I live with," said Gareth, who lives in Cardiff. "This is
what I live with every day."

Today just 378 of the 1,238 people infected with HIV from unscreened,
infected NHS blood products are still alive - a further 4,800 people
were infected with hepatitis. If all these people had died at once - if
this had been a tragic plane crash or shipping disaster - there would
have been a huge outpouring of public grief and anger. As it is, they
have died with depressing regularity over the past 20 years, very much
off the public's radar.

Gareth was told he was HIV-positive 22 years ago. He developed
full-blown Aids about nine years ago. In the mid-'80s he was told he
also had hepatitis C. Most recently he has been "advised" by the
Government that he was probably exposed to new variant CJD - the human
form of mad cow disease. How does that feel? What's one more
life-threatening illness on top of the others, he asks?

"I've learned to live with HIV and Aids; I learned to live with
hepatitis C, and then I get a letter saying I've been exposed to CJD,"
he said.

"I wonder what's around the corner for me. Although I'm trying to live
as normal a life as possible, it's very difficult."

Gareth, like thousands of other haemophiliacs in Britain, is dependent
on a blood product known simply as Factor VIII to ensure his blood is
able to clot normally.

He was born with the condition and takes Factor VIII - which today, for
most Welsh patients at least, is 100% synthetic, although it still
originates from America - whenever he suffers from trauma or accident.

"Without Factor VIII my blood will not clot, without treatment any form
of trauma, injury or internal bleeding will not stop. I can wake up in
the middle of the night with a bleed - it doesn't have to be anything
significant, it can be a spontaneous bleed caused by lying on a shoulder
for too long.

"Because I've had haemophilia all my life it has been something that I
have just got on with - the same with HIV and hepatitis C and now with
new variant CJD. I take it in my stride - what else is there to do?

"I've been very ill with various illnesses but I must keep that sense of
hope and a positive attitude. I'm determined that I will beat this and
that nothing I receive to make me better will kill me."

For decades the NHS imported stocks of Factor VIII from the US where
they were made from thousands of pooled blood donations.

Most countries rely on voluntary blood donations, but in the US it has
been the practice to pay donors for their blood and plasma - in many
cases the donors who made up the samples used to make Factor VIII were
prisoners and people living on Skid Row. Both of these groups had high
incidences of hepatitis disease and were more likely to be contaminated
- just four infected donors could contaminate an entire year's supply of
Factor VIII.

Liberal Democrat MP Patsy Calton said, in a speech earlier this year,
"Haemophilia patients were being subjected to a form of Russian roulette
where the barrel had just one bullet missing."

The World in Action programme Blood Money, broadcast in 1975, featured
an extract of a letter from the US-based world-renowned hepatitis expert
Dr J Garrott Allen to William Maycock, the then head of the British
Blood Transfusion Service, which read, "Commercial blood banking
perpetuates the high-risk rates for hepatitis we encounter with their
products and it also tempts these same firms to sell residual products.

"It does not take much commercial blood in a mixed combination to bring
up an astounding attack rate from one that is relatively unnoticed, this
is the basis of my concern about Britain purchasing commercial blood
products from our country."

Experts first became aware that there was something wrong with the
Factor VIII used to treat haemophiliacs in Britain as early as the mid
1970s.

Dr Charles Rizza, of the Oxford Haemophilia Centre, said, "We recognised
in the mid 1970s and early 1980s that all of the concentrates were
infected with non-A and non-B hepatitis. The only way we knew was that
when we had someone who needed Factor VIII but who did not have
hepatitis, we would transfuse him and he would invariably get hepatitis
but not hepatitis A or hepatitis B."

In 1975, the World Health Organisation guidelines about the collection
and use of blood products said, "Donor populations showing a prevalence
of acute or chronic hepatitis higher than that found in the general
population should be avoided for collection both of single donor
products and of plasma for pooling for the manufacture of plasma
fractions know to be capable of transmitting hepatitis, such as clotting
factor concentrates.

"Countries with a low incidence of hepatitis should not use whole blood
or blood products obtained from source material collected in an area
where there is a high incidence of hepatitis."

But until the mid 1980s, the NHS continued to import 80% of blood
products used to treat haemophiliacs - the first case of Aids in a UK
haemophiliac was identified in 1983.

In the US lawsuit against the American companies which manufactured
Factor VIII, it is alleged that at least three of these companies not
only knowingly recruited and paid donors from high-risk populations,
including prisoners and IV-drug users, but that they "fraudulently
misrepresented" to government officials and the public that Factor VIII
was safe to use.

Even after donors were tested for hepatitis and for HIV, haemophiliacs
in Britain continued to be infected because heat-treating was not
introduced as fast as it could have been; donor exclusion was voluntary
for too long and artificial Factor VIII is still not available to all
haemophiliacs.

But this is only part of the scandal - the surviving haemophiliacs
branded with the stigma of HIV and Aids, and the families of those who
have already died, still do not know the full story of what went wrong
and why the mistakes that will claim their lives were allowed to be made.

There have been accusations of a government cover-up of the true facts,
and even the recompense scheme - payments to those infected with HIV and
hepatitis through blood and blood products but not compensation -
announced by ministers has failed to stem fears that the full story will
never be known.

Instead of answers to their long-ignored questions and the promise of a
full and independent public inquiry, haemophiliacs are today receiving
letters advising them of the CJD risk.

Jocelyn Davies, Plaid Cymru AM for South Wales East, said, "This issue
deserves a full public inquiry to see exactly who knew what and when,
what actionwas taken and how the Government justifies what it did and
didn't do.

"I don't think the dangers of the treatment were ever really explained
to patients to enable them to make an informed choice about their
treatments.

"I'm sure there are lessons to be learned and we would probably find
that the Government had a duty of care that it didn't meet."

http://icwales.icnetwork.co.uk/0100news/0200wales/tm_objectid=14987056&method=full&siteid=50082&headline=i-m-just-waiting-to-die-name_page.html

TSS

############## BSE-L-subscribe-request@kaliv.uni-karlsruhe.de ##############

RE-I'm just waiting to die

I just ponder who else is waiting to die and don't know it ;

December 8, 2004
04-49

PRODUCT
a) Red Blood Cells. Recall # B-0233-5;
b) Platelets. Recall # B-0234-5;
c) Recovered Plasma. Recall # B-0235-5.
CODE
a), b), and c) Unit KT06478.
RECALLING FIRM/MANUFACTURER
Innova Health Care Services, Blood Donor Services, Annandale , VA , by letter on June 2, 2004 and by fax on June 3, 2004 . Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk of exposure to Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA and NJ.

_______________________________

PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-0236-5;
b) Fresh Frozen Plasma. Recall # B-0237-5.
CODE
a) and b) Unit KS16926
RECALLING FIRM/MANUFACTURER
Innova Health Care Services, Blood Donor Services, Annandale , VA , by letter on March 22, 2003 . Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk of exposure to Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_______________________________

PRODUCT
Source Plasma. Recall # B-0259-5.
CODE
Units 96912577, 96919484, 96896099, 96891483, 96886854, 96873878, 96869758, 96859926, 96853344, 96849873, 96832844, 96829110.
RECALLING FIRM/MANUFACTURER
ZLB Plasma Services, Inc., Kansas City , MO , by letter dated February 10, 2004 . Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who did not answer the CJD questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
CA.

_______________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00877.html

PRODUCT
Recovered Plasma. Recall # B-1886-4.
CODE
Unit 11GQ51677.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO, by facsimile on
February 20, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was at increased
risk for Creuztfeldt Jakob Disease (CJD) due to having lived in Europe
between 1984 - 1987, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1889-4;
b) Platelets, Leukocytes Reduced. Recall # B-1890-4;
c) Recovered Plasma. Recall # B-1891-4.
CODE
a), b), and c) unit number 33GE80466.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by
facsimile on April 28, 2004, telephone on May 28, 2004, and letter on
June 2, 2004. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of
travel to an area considered at increased risk of exposure to variant
Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CT, and CA.

_______________________________

PRODUCT
a) Red Blood Cells. Recall # B-1892-4;
b) Fresh Frozen Plasma. Recall # B-1893-4.
CODE
a) and b) Unit number 4227074.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated November 25,
2002. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of
travel to an area considered at increased risk of exposure to variant
Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AK.

_______________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00864.html

PRODUCT
a) Plasma, Frozen. Recall # B-1826-4;
b) Cryoprecipitated AHF. Recall # B-1827-4;
c) Recovered Plasma. Recall # B-1828-4.
CODE
a) Unit number: 11GR34665;
b) and c) Unit number: 11GZ36568.
RECALLING FIRM/MANUFACTURER
American Red Cross, Missouri-Illinois Region, St. Louis, MO, by
telephone on January 16, 2003, by letter dated January 22, 2003, and by
facsimile on January 28, 2003. 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 for variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MO and Switzerland.

_______________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00863.html

TSS

Terry S. Singeltary Sr. wrote:

######## Bovine Spongiform Encephalopathy
#########

JUNE/JULY 2004 BLOOD RECALL UPDATE vCJD ONLY

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1630-4;
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-1631-4;
c) Platelets Pheresis, Leukocytes Reduced.
Recall # B-1632-4;
d) Platelets Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-1633-4;
e) Fresh Frozen Plasma. Recall # B-1634-4;
f) Plasma, Frozen. Recall # B-1635-4;
g) Red Blood Cells, For Manufacturing Use Only.
Recall # B-1636-4;
h) Recovered Plasma. Recall # B-1637-4.
CODE
a) Unit numbers: 40FF51296, 40FF51405, 40FF51479,
40FF51604, 40FF51657, 40FF51800, 40FF51838, 40FF51877,
40FF51968, 40FF51998, 40FF52129, 40FF52254, 40FF52264,
40FF52289, 40FF52457, 40FF52659, 40FF52674, 40FF52766,
40FF52771, 40FF53014, 40FF53115, 40FF53274, 40FF53342,
40FF53648, 40FF53690, 40FF53731, 40FF53757, 40FF53955,
40FF54040, 40FF54053, 40FF54211, 40FF54214, 40FF54346,
40FF54350, 40FF54372, 40FF54381, 40FF54440, 40FF54576,
40FF55054, 40FF55105, 40FF55120, 40FF55131, 40FF55190,
40FF55492; 40FQ31137, 40FQ31160, 40FQ31258, 40FQ31317,
40FQ31357, 40FQ31366, 40FQ31489, 40FQ31564, 40FQ31575,
40FQ31594, 40FQ31642, 40FQ31686, 40FQ31753, 40FQ31772,
40FQ31817, 40FQ31853, 40FQ31926, 40FQ31970, 40FQ32061,
40FQ32085, 40FQ32195, 40FQ32253, 40FQ32279, 40FQ32337,
40FQ32341, 40FQ32363, 40FQ32430, 40FQ32460, 40FQ32526,
40FQ32555, 40FQ32606, 40FQ32721, 40FQ32736, 40FQ32753,
40FQ32768, 40FQ32843, 40FQ33067, 40FQ33152, 40FQ33183,
40FQ33427, 40FQ33609, 40FQ33658, 40FQ33673, 40FQ33787,
40FQ33798, 40FQ33973;
b) Unit numbers: 40FF51164, 40FQ31378, 40FQ31694;
c) Unit numbers: 40FP16037-2, 40FP16497-1, 40FP16746-1,
40FP17118-1, 40FP17118-2, 40FP18019-1, 40FP18019-2;
d) Unit numbers: 40FP15763-1, 40FP16746-2;
e) Unit numbers: 40FQ31694, 40FQ32061, 40FQ32768,
40FQ33658, 40FQ33673, 40FQ33787;
f) Unit numbers: 40FF52129, 40FF54440, 40FF55105,
40FF55120, 40FQ32279, 40FQ32341;
g) Unit number: 40FQ32200;
h) Unit numbers: 40FF51164, 40FF51174, 40FF51296,
40FF51405, 40FF51479, 40FF51604, 40FF51657, 40FF51800,
40FF51838, 40FF51877, 40FF51968, 40FF51998, 40FF52254,
40FF52264, 40FF52289, 40FF52457, 40FF52655, 40FF52659,
40FF52674, 40FF52766, 40FF52771, 40FF53014, 40FF53115,
40FF53274, 40FF53342, 40FF53648, 40FF53690, 40FF53731,
40FF53757, 40FF53955, 40FF54040, 40FF54053, 40FF54211,
40FF54214, 40FF54346, 40FF54350, 40FF54372, 40FF54381,
40FF54576, 40FF55054, 40FF55131, 40FF55190, 40FF55492,
40FQ31137, 40FQ31160, 40FQ31258, 40FQ31317, 40FQ31357,
40FQ31366, 40FQ31378, 40FQ31489, 40FQ31564, 40FQ31575,
40FQ31594, 40FQ31642, 40FQ31686, 40FQ31753, 40FQ31772,
40FQ31817, 40FQ31853, 40FQ31926, 40FQ31970, 40FQ32085,
40FQ32195, 40FQ32200, 40FQ32253, 40FQ32337, 40FQ32363,
40FQ32430, 40FQ32460, 40FQ32526, 40FQ32555, 40FQ32606,
40FQ32721, 40FQ32736, 40FQ32753, 40FQ32843, 40FQ33067,
40FQ33152, 40FQ33183, 40FQ33427, 40FQ33609, 40FQ33973,
40FQ33798.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of America, Peoria, IL, by telephone
on March 23-24, 2004 and by letter dated March 31, 2004. Firm initiated
recall is complete.
REASON
Blood products, collected from donors whose medical history screening
regarding risk factors for variant Creutzfeldt-Jacob disease (vCJD) was
incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
199 units.
DISTRIBUTION
Nationwide and Switzerland.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00856.html

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1555-4.
CODE
Unit number 49GR60806.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by letters
on July 1, 2002, August 20, 2002, and September 6, 2002. Firm initiated
recall is complete.
REASON
Blood product collected from an unsuitable donor due to a history of
travel to an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00855.html

PRODUCT
Source Plasma. Recall # B-1539-4.
CODE
Unit numbers: ST323408, ST323790, ST324131, and ST324474.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., San Antonio, TX, by facsimile on June 26,
2003. Firm initiated recall is complete.
REASON
Blood products were not properly quarantined after the donor disclosed a
history of travel to an area considered at increased risk of exposure to
new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC. _______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1543-4;
b) Recovered Plasma. Recall # B-1544-4.
CODE
a) and b) Unit number LS86931.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by
facsimile on November 29,2002, by telephone on December 18, 2002, and
letter on December 24, 2002. Firm initiated recall is complete.
REASON
Blood products collected from an ineligible donor based on the
disclosure of a family member diagnosed with Creutzfeldt-Jakob Disease
(CJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WI and Switzerland. _______________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00854.html

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1493-4;
b) Recovered Plasma. Recall # B-1494-4.
CODE
a) and b) Unit number: 02FE08982.
RECALLING FIRM/MANUFACTURER
American Red Cross, Central Plains Region, Wichita, KS, by telephone on
September 4, 2002, by facsimile on September 9, 2002, and by letter,
dated September 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on a history of
residing in an area considered at increased risk of exposure to variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KS and CA. _______________________________

PRODUCT
Recovered Plasma. Recall # B-1501-4.
CODE
Unit 11GN56565.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by
facsimile on May 29, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of
travel to an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland. _______________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00853.html

PRODUCT
Recovered Plasma. Recall # B-0780-4.
CODE
Unit number 9030179.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by facsimile on March 31, 2004. Firm
initiated recall is complete.
REASON
Blood product, 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), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00852.html

PRODUCT
Source Plasma. Recall # B-1357-4.
CODE
Unit numbers: 0069302, 0069478, 0069923, 0070090, 0075043, 0075384, and
0078620.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wichita Falls, LLC, Wichita Falls, TX, by facsimile on
August 28, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for
variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
KY.

PRODUCT
Source Plasma. Recall # B-1380-4.
CODE
Unit numbers 02DOHA1853, 02DOHA2202, 02DOHA2830, 02DOHA3192, and
02DOHA3534.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Dayton, OH, by facsimile on June 5, and
13, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of
travel to an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CA. _______________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00850.html

-------- Original Message --------
Subject: Docket #03-025IF -- Docket #03-038IF -- Docket #01-033DF --
SUBMISSIONS -- USDA ISSUES NEW REGULATIONS TO ADDRESS BSE
Date: Thu, 08 Jan 2004 15:33:20 -0600
From: "Terry S. Singeltary Sr."
To: fdadockets@oc.fda.gov
CC: Freas@cber.FDA.gov

Greetings FDA,

I would kindly like to make a submission to Federal Docket Docket
#03-025IF -- Docket #03-038IF and
Docket #01-033DF -- TSS SUBMISSIONS -- USDA ISSUES NEW REGULATIONS
TO ADDRESS BSE

snip...

vCJD: Blood Transfusion Incident

3.58 p.m.

Lord Warner: My Lords, with permission, I wish to repeat a Statement
made by my right honourable friend the Secretary of State for Health in
another place. The Statement is as follows:

full text;

http://www.publications.parliament.uk/pa/ld199697/ldhansrd/pdvn/lds03/text/31217-09.htm

http://neuro-mancer.mgh.harvard.edu/ubb/Forum24/HTML/000231.html

TSS

######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html
##########

JUNE/JULY 2004 BLOOD RECALL UPDATE vCJD ONLY

http://www.fda.gov/bbs/topics/enforce/2004/ENF00856.html

_______________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00855.html

http://www.fda.gov/bbs/topics/enforce/2004/ENF00854.html

http://www.fda.gov/bbs/topics/enforce/2004/ENF00853.html

http://www.fda.gov/bbs/topics/enforce/2004/ENF00852.html

PRODUCT
Source Plasma. Recall # B-1380-4.
CODE
Unit numbers 02DOHA1853, 02DOHA2202, 02DOHA2830, 02DOHA3192, and 02DOHA3534.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Dayton, OH, by facsimile on June 5, and
13, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of
travel to an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CA. _______________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00850.html

Greetings FDA,

I would kindly like to make a submission to Federal Docket Docket
#03-025IF -- Docket #03-038IF and
Docket #01-033DF -- TSS SUBMISSIONS -- USDA ISSUES NEW REGULATIONS
TO ADDRESS BSE

snip...

vCJD: Blood Transfusion Incident

3.58 p.m.

Lord Warner: My Lords, with permission, I wish to repeat a Statement
made by my right honourable friend the Secretary of State for Health in
another place. The Statement is as follows:

full text;

http://www.publications.parliament.uk/pa/ld199697/ldhansrd/pdvn/lds03/text/31217-09.htm

http://neuro-mancer.mgh.harvard.edu/ubb/Forum24/HTML/000231.html

TSS

######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html ##########

PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall B-0008-5.
CODE
Unit number 6684748 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Sarasota, FL, by telephone on October
28, 2003. Firm initiated recall is complete.
REASON
Blood product, 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), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.

_______________________________

PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0025-5;
b) Cryoprecipitated AHF, Recall # B-0026-5;
c) Plasma Cryoprecipitate Reduced, Recall # B-0027-5.
CODE
a), b), and c) Unit 20GM75704.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Boise, ID, by telephone on April 4,
2003 and by letter dated August 6, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for
Creuztfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MT.
_______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0036-5;
b) Fresh Frozen Plasma. Recall # B-0037-5.
CODE
a) and b) Unit number 2383755.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
February 4, 2003, and August 13, 2003. 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 variant
Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS ‚ CLASS III

_______________________________

PRODUCT
Recovered Plasma. Recall # B-0012-5.
CODE
Unit numbers D03-02509 and D04-00404.
RECALLING FIRM/MANUFACTURER
Metrowest Medical Center, Farmingham, MA, by letter on August 10, 2004.
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 variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
_______________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00869.html

TSS

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PRODUCT
Source Plasma. Recall # B-0004-5.
CODE
Units BY0081013, BY0081234, BY0081539, BY0081749, BY0082116, BY0082324,
BY0082909, BY0082977.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Bryan, LLC, Bryan, TX, by facsimile dated November 6,
2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in western Europe, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
NY.

___________________________________

PRODUCT
Source Plasma. Recall # B-0038-5.
CODE
Units CS0179785, CS0195693.
RECALLING FIRM/MANUFACTURER
Westgate Biologicals, LLC, College Station, TX, by letter dated January
2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new
variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY.

_______________________________

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0041-5.
CODE
Unit 2372493 (split unit).
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
March 7, 20, and 27, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for
Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________

PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # 0044-5;
b) Fresh Frozen Plasma. Recall # B-0045-5.
CODE
a) and b) Unit 2374447.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
January 22, and February 21, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was at risk for
Creutzfeldt-Jakob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0049-5;
b) Recovered Plasma. Recall # B-0050-5.
CODE
a) and b) Unit 2368943.
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile dated
February 13, 2003, and April 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in western Europe, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Vienna, Austria, and TX.
_______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0056-5;
b) Cryoprecipitated AHF. Recall # B-0057-5;
c) Recovered Plasma. Recall # B-0058-5.
CODE
a), b), and c) Unit number 2372945.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
February 25, 2003. 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 variant
Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX, and Switzerland.

_______________________________

PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0059-5;
Recovered Plasma. Recall # B-0060-5.
CODE
a) and b) Unit number 2348391.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
February 12, and 19, 2003. 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 variant
Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and Austria.

_______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0080-5;
b) Fresh Frozen Plasma. Recall # B-0081-5.
CODE
a) and b) Unit 2356608.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
March 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for
Creuztfeldt Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________

END OF ENFORCEMENT REPORT FOR October 20, 2004

http://www.fda.gov/TSS

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