FDA Proposes Barring Certain Cattle Material From Medical Products As BSE Safeguard

[flatfish]

FOR IMMEDIATE RELEASE
P07-04
January 11, 2007
Media Inquiries:
Karen Riley, 301-827-6242
Consumer Inquiries:
888-INFO-FDA



FDA Proposes Barring Certain Cattle Material From Medical Products As BSE Safeguard

The U.S. Food and Drug Administration is proposing to limit the materials used in some medical products in order to keep them free of the agent thought to cause mad cow disease, also known as bovine spongiform encephalopathy or BSE.

This is the latest in a series of BSE safeguards that would bar material that has been found to harbor the highest concentrations of this fatal agent in infected cattle. These materials would be prohibited from use as ingredients in medical products or elements of product manufacturing.

The proposed rule would cover drugs (prescription, over-the-counter, and homeopathic), biologics (such as vaccines) and medical devices intended for use in humans as well as drugs intended for use in ruminant animals like cattle and sheep. Cattle can get mad cow disease, while sheep can get a similar disease known as scrapie.

"These measures build on a series of barriers FDA and the U.S. Department of Agriculture have erected to further protect humans from exposure to the fatal agent linked to BSE," said Andrew von Eschenbach, M.D., Commissioner Food and Drugs. "This proposed rule adds one more safeguard that will reduce the risk of transmission even further."

The cattle materials prohibited in the proposed rule are those that pose the highest risk of containing infectious material and include:

the brain, skull, eyes and spinal cords from cattle 30 months and older;
the tonsils and a portion of the small intestines from all cattle regardless of their age or health;
any material from "downer" cattle--those that cannot walk;
any material from cattle not inspected and passed for human consumption;
fetal calf serum if appropriate procedures have not been followed to prevent its contamination with materials prohibited by this proposed rule;
tallow that contains more than 0.15 percent insoluble impurities if the tallow is derived from materials prohibited by this proposed rule and;
mechanically separated beef.
To ensure that companies comply with these prohibitions, FDA proposes to require that records be kept to demonstrate that any cattle material used as an ingredient in these medical products or as part of their manufacturing process meet the rule’s requirements.

Since 1996, strong evidence has accumulated for a causal relationship between ongoing outbreaks of mad cow disease in Europe and a disease in humans called variant Creutzfeldt-Jakob (vCJD) disease. Both disorders, which are thought to be caused by an unconventional transmissible agent, are invariably fatal brain diseases with incubation periods typically measured in years. Transmission of the BSE agent to humans, leading to vCJD, is believed to occur via ingestion of cattle products contaminated with the BSE agent; however the specific products associated with this transmission are unknown.

About 200 cases of vCJD have been identified worldwide, including three cases in the U.S. However, there is no evidence that those three patients contracted the BSE agent in the U.S.

FDA and USDA’s efforts to help protect the public from vCJD have included several other significant steps such as the FDA’s 1997 ruminant feed regulation, which forbids the use of certain mammalian-origin proteins in ruminant feed. Also, a 2005 interim final rule bans the use of certain high-risk cattle material in food, dietary supplements and cosmetics.

####



http://www.fda.gov/bbs/topics/NEWS/2007/NEW01545.html






http://www.fda.gov/OHRMS/DOCKETS/AC/01/slides/3681s2_09.pdf



http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/96n0417/96N-0417-EC-2.htm



http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/96n0417/96N-0417-EC-2.htm



http://www.microbes.info/forums/lofiversion/index.php/t377.html



http://www.whale.to/v/cjd1.html



http://www.mad-cow.org/00/may00_news.html



http://www.mad-cow.org/00/feb01_news_mid.html



TSS

[flatfish]

Subject: U.S.A. - 50 STATE BSE CONFERENCE CALL JAN. 9, 2001 (my notes)
Date: January 10, 2001 at 1:36 pm PST

Subject:
BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date:
Tue, 9 Jan 2001 16:49:00 -0800
From:
"Terry S. Singeltary Sr."
Reply-To:
Bovine Spongiform Encephalopathy
To:
BSE-L@uni-karlsruhe.de



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

Greetings List Members,

I was lucky enough to sit in on this BSE conference
call today and even managed to ask a question.
that is when the trouble started.

I submitted a version of my notes to
Sandra Blakeslee of the New York Times,
whom seemed very upset, and rightly
so.

"They tell me it is a closed meeting and
they will release whatever information
they deem fit. Rather infuriating."

and i would have been doing just fine,
until i asked my question. i was surprised
my time to ask a question so quick.

(understand, these are taken from my notes for now.
the spelling of names and such could be off.)

[host Richard Barns]
and now a question from Terry S. Singeltary of
CJD Watch.

[TSS]
yes, thank you,
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question
again.]

[host Richard]
could you repeat the question?

[TSS]
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[not sure whom ask this]
what group are you with?

[TSS]
CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.

[not sure who is speaking]
could you please disconnect Mr. Singeltary

[TSS]
you are not going to answer my question?

[not sure whom speaking]
NO

from this point, i was still connected, got to listen
and tape the whole conference. at one point someone
came on, a woman, and ask again;

[unknown woman]
what group are you with?

[TSS]
CJD Watch and my Mom died from hvCJD
we are trying to tract down CJD and other
human TSE's world wide. i was invited to
sit in on this from someone inside the USDA/APHIS
and that is why i am here. do you intend on banning
me from this conference now?

at this point the conference was turned back up,
and i got to finish listening. They never answered
or even addressed my one question, or even addressed
the issue. BUT, i will try and give you a run-down
for now, of the conference.

IF i were another Country, I would take heed to my
notes, BUT PLEASE do not depend on them. ask for
transcript from;

RBARNS@ORA.FDA.GOV
301-827-6906

he would be glad to give you one ;-)

Rockville Maryland,
Richard Barns Host

BSE issues in the U.S.,
How they were labelling ruminant feed?
Revising issues.

The conference opened up with the explaining of
the U.K. BSE epidemic winding down with about 30
cases a week.

although new cases in other countries were now
appearing.

Look at Germany whom said NO BSE and now have BSE.

BSE increasing across Europe.

Because of Temporary Ban on certain rendered product,
heightened interest in U.S.

A recent statement in Washington Post, said the
New Administration (old GW) has a list of issues.
BSE is one of the issues.

BSE Risk is still low, minimal in U.S. with a greater
interest in MBM not to enter U.S.

HOWEVER, if BSE were to enter the U.S.
it would be economically disastrous
to the render, feed, cattle, industries,
and for human health.

(human health-they just threw that in cause i was listening. I will now
jot down some figures in
which they told you, 'no need to write them down'.
just hope i have them correct. hmmm, maybe i hope
i don't ???)

80% inspection of rendering

*Problem-Complete coverage of rendering HAS NOT
occurred.

sizeable number of 1st time FAILED INITIAL INSPECTION,
have not been reinspected (70% to 80%).

Compliance critical, Compliance poor in U.K.
and other European Firms.

Gloria Dunason
Major Assignment 1998 goal TOTAL compliance.
This _did not_ occur. Mixed level of compliance,
depending on firm.

Rendering FDA license and NON FDA license

system in place for home rendering & feed
76% in compliance
79% cross contamination
21% DID NOT have system
92% record keeping
less than 60% total compliance

279 inspectors
185 handling prohibited materials

Renderer at top of pyramid, significant
part of compliance.
84% compliance

failed to have caution statement render
72% compliance & cross contamination
caution statement on feed, 'DO NOT FEED TO CATTLE'

56 FIRMS NEVER INSPECTED

1240 FDA license feed mills
846 inspected

"close to 400 feed mills have not been inspected"

80% compliance for feed.

10% don't have system.

NON-FDA licensed mills
There is NO inventory on non licensed mills.
approximately 6000 to 8000 Firms ???
4,344 ever inspected.
"FDA does not have a lot of experience with"

40% do NOT have caution statement 'DO NOT FEED'.

74% Commingling compliance

"This industry needs a lot of work and only half
gotten to"

"700 Firms that were falitive, and need to be
re-inspected, in addition to the 8,000 Firms."

Quote to do BSE inspection in 19 states by end
of January or 30 days, and other states 60 days.
to change feed status??? Contract check and ask
questions and pass info.

At this time, we will take questions.

[I was about the third or fourth to ask question.
then all B.S.eee broke loose, and i lost my train
of thought for a few minutes. picked back up here]

someone asking about nutritional supplements and
sourcing, did not get name. something about inspectors
not knowing of BSE risk??? the conference person assuring that Steve
Follum? and the TSE advisory Committee were
handling that.

Some other Dr. Vet, whom were asking questions
that did not know what to do???

[Dennis Wilson]
California Food Agr.
Imports, are they looking at imports?

[Conference person]
they are looking at imports,
FDA issued imports Bulletin.

[Linda Singeltary ??? this was a another phone in
question, not related i don't think]
Why do we have non-licensed facilities?

(conference person)
other feed mills do not handle as potent drugs???

Dennis Blank, Ken Jackson
licensed 400
non FDA 4400 inspected of a total of 6000 to 8000,

(they really don't know how many non licensed Firms
in U.S. they guess 6000 to 8000??? TSS)

Linda Detwiler
asking everyone (me) not to use emergency BSE number,
unless last resort.
(i thought of calling them today, and reporting the
whole damn U.S. cattle herd ;-) 'not'

Warren-Maryland Dept. Agr.
Prudent to re-inspect after 3 years.
concerned of Firms that have changed
owners.

THE END

TSS

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

[ainee]

TSS - You sure got fobbed off when you asked the conference about what kind of guarantee etc. -
Why won't these people listen? - are they afraid that someone may find a simple answer to something they can't?
In your information it says - "Cattle can get mad cow disease, while sheep can get a similar disease known as scrapie." - Our sheep were scientifically diagnosed in 2001, with PEM - Polioencephalomalacia or CN - Cerebrocortical Necrosis - which means wasting or decaying of the brain. They also had neurological symptoms similar to scrapie. PEM or CN, have similar symptoms to BSE and also similar symptoms to CJD - give or take a few and put into human terms. The brain wastes and decays - along with other neurological symptoms - and the person dies - just like our sheep. The treatment for our sheep - if they had lived - would have been VB1 injections. But just one small dosed injection would not have been sufficiant. The dose for PEM was increased (info in the Hungerfords Diseases of Livestock) - it said that 250 mgs was not successful, but 400mgs was. The flock had to be inspected 3 times a day. So if any stock showed neurological symptoms, they could be treated more often if neccessary. A cow was also successfully treated for toxaemia and diagnosed as with PEM - as are many other animal PEM cases I've found on the internet. The treatment of the VB1 is determined by the weight.

I'm asking why can't a simple treatment such as VB1, which is a treatment for PEM in livestock, be given to humans who have CJD - or susspected CJD?
I believe from my research, it doesn't matter what strain of CJD is diagnosed, or what the cause is - VB1 could be a successful treatment. It seems that time is wasted trying to find what is wrong with an ill person, perhaps with many misdiagnoses along the way - time has probably been a killer in itself.
VB1 is the scientifically tested treatment for similar neurological symptoms + brain wasting and decaying symptoms in stock - then couldn't it be a simple treatment to give someone who is suffering similar symptoms, more time?
Anyone can buy VB1 tablets from the chemist - drug store - for human use without a perscription - it just has to be taken in the right dose quantity per body weight and the correct dose rate to be successful.
ainee.

[flatfish]

see full text docket and submit your thoughts ;


http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/E6-22329.htm



TSS

[ainee]

G'day TSS,
Contaminated products are probably by now, wide spread - only time will tell if - and when - someone gets a TSE from cattle products - or from some other unknown source. I haven't thought til now about prohibiting the manufacture of any products from stock that are likely to be infected. I guess knowledge of where these infected stock are, and where they end up, is going to make sure they are not used in any way, for human or animal use.
But once you've got a TSE, you've got it - regardless of what contaminated matter you've been exposed to.

Some CJD/TSE cases may be from contaminated food and products, but I also believe from my experience and research into other neurological symptoms, that injury and/or toxins - even after years of the exposure as in my case - could be a cause that medical scientists haven't even explored yet. Our sheep with PEM, would have eaten grass which can be very toxic at certain times of the year. This is perhaps how BSE first started - from cattle eating toxic grain, hay etc., then over time (before it was detected) the contaminated food and products entered the food and process chain - infecting humans.

It seems time is wasted - why isn't VB1 - the treatment for livestock displaying similar symptoms to CJD and other TSE's - be given as a treatment to humans until tests are carried out?
Awareness and knowledge are powerful tools - so is the experience in having similar symptoms as our sheep with PEM - and treating myself with the simple treatment. The knowledge of our sheep's symptoms and treatment was also my survival, when the chips were down.

Many millions of dollars are spent each year trying to find a solution - while one (or more) in a million people are dying. For about $1 a day, the treatment for PEM in sheep, would be pretty good value. VB1 - suppressed and eventually reverse the symptoms I displayed, which were similar to our sheep's PEM symptoms. I wonder when someone is going to suggest 'they' try VB1 as a treatment for those displaying similar symptoms - VB1 is here and now - it's been successfully scientifically tested as a treatment for livestock displaying similar symptoms to CJD in humans. It could give hope to many ill people - until 'they' round up the 'red steer'.

[flatfish]

[QUOTE=ainee;49576]

It seems time is wasted - why isn't VB1 - the treatment for livestock displaying similar symptoms to CJD and other TSE's - be given as a treatment to humans until tests are carried out?
Awareness and knowledge are powerful tools - so is the experience in having similar symptoms as our sheep with PEM - and treating myself with the simple treatment. The knowledge of our sheep's symptoms and treatment was also my survival, when the chips were down.

QUOTE]


because it does not work. simple as that.


what part of i don't want to discuss your snake oil cure do you not understand.


once again annie, i wish not to communicate any of your nonsense, or to discuss your snake oil cure.


who you are, and or why you follow me and post this crap is beyond me.
your junk will not cure cjd, and to come to these boards and pass this false
hope to these poor people is beyond cruel.


history of ainne repulsive nonsense once again ;




ainee still chasing the dead with her snake oil cure, SHAME ON YOU AINEE !!!

please go away and leave these people alone.......


Monday 10/30/2006 9:33:10am
Name: TOM WILEBSKI
E-Mail: TOMW@NORTHDALECONST.COM
Homepage Title:
Homepage URL:
Referred By: Search Engine
Location: MINNEAPOLIS, MINNESOTA
Comments: 1 AM ABOUT TO LOSE A DEAR FRIEND TO CJD AND IT MAKES MY HEART ACHE SO BADLY.

THANK YOU


Sunday 07/02/2006 2:38:50am
Name: ainee
E-Mail:
Homepage Title:
Homepage URL:
Referred By: Search Engine
Location:
Comments: I wonder if those suffering neurological symptoms - including CJD, have ever been to see an Osteopath? I saw one in 2001, soon after my horrific neurological symptoms started - he said that my back muscles were "all knotted up." I believe this was caused by an accident in 1995, which in time caused damage to my muscles and nervous system, and caused the horrific neurological symptoms which I had. No tests of any kind have shown the cause of my symptoms - so maybe "knotted up back muscles", could be a way of diagnosing neurological illnesses and conditions.
I treated myself with an easy treatment which was scientifically tested in treating neurological illness PEM in sheep. PEM has similar symptoms to CJD, and my symptoms were similar to our sheep who were diagnosed with PEM.
I experimented and found 250mgs Vitamin B1 3 or 4 times a day, suppressed the symptoms in a short time after each dose. I rose the dose to 500mgs 3 times a day - and after 18 months of experimentation, my neurological symptoms started to reverse. I am reasonably well now, with only a few symptoms that I can cope with. Do NOT take VB1 if on pain relief.
I wonder - does "knotted up back muscles", have anything to do with many neurological and CJD symptoms. My bet it has everything to do with it.
ainee.
Tuesday 03/14/2006 1:37:53pm
This is a private entry.

If you are the owner of this guestbook, you can press the button to view this entry.


Tuesday 12/06/2005 9:10:36pm
Name: ainee
E-Mail: ainee.pv@hotmail.com
Homepage Title:
Homepage URL:
Referred By: Search Engine
Location: MY STORY MAY GIVE HOPE
Comments: I wrote in this guest book on the 17th November 2005. I made an error. Where I said -I took 250 mgs Vitamin C, 3 or 4 times a day -it should have read Vitamin B1. The rest is OK. ainee.


Thursday 11/17/2005 8:28:08pm
Name: ainee
E-Mail:
Homepage Title:
Homepage URL:
Referred By: Search Engine
Location: MY STORY MAY GIVE HOPE
Comments: Perhaps my story will give hope to those who are ill.
I discovered that my horrific symptoms were similar to CJD. I took 250 mgs. of Vitamin C, 3 or 4 times a day. My symptoms subsided a short time after each dose. After much experimentation, I rose my dose to 500 mgs. 3 times a day.

I also discovered that 3000 mgs. Vitamin C - or one teaspoon of Vitamin C powder - 3 times a day, also helped to reverse the symptoms, which were similar to toxin symptoms, eg. chemicals. (I could choose either VB1, or Vitamin C tablets, or Vitamin C powder, any ONE of these 3 times a day - a different one at each dose if I wished.

A lesser dose didn't work as well. I had to take the right amount for my weight - average adult. If I were a frail person, half the above dose rates, 3 times a day would have been sufficiant.I experimented with many other treatments. I was still very ill. It took 18 months before my symptoms started to reverse and another year to get as well as I am now, reasonably well most of the time.

I believe that toxin and/or injury that I was exposed to years ago, could have been the cause of my illness. I was never tested for CJD. I am not a medical person, just someone who has survived a living ****. This treatment is not a cure, but could give better health and hope to those who are ill with similar symptoms.

I would advise anyone NOT to change their medication without seing their doctor.

God bless
ainee.


http://htmlgear.tripod.com/gw/guest/control.guest?u=bmathews&a=view&i=1&r=http://www.google.com/search%3fnum=30&hl=en&lr=&edition=us&q=cjd+ainee&btnG=Search


Wednesday 10/25/2006 1:33:47am
Name: Jane Lucas
E-Mail: janeylucas@yahoo.com
Homepage Title:
Homepage URL:
Referred By: Just Surfed In
Location: Australia
Comments: My 24 year old fiance passes away in 2000. I found out xams eve that he was diagnosed with nv CJD.

I have moved from England to Oz in the hope to move on....... I think about Matt every single day and cry for his family all the time. I live in fear that I also have nv CJD, I have no symptoms but wonder if my time will come.

Feel free to email me if you to need a friend.

continued

[flatfish]

Tuesday 09/05/2006 1:05:31pm
Name: Linda Cook
E-Mail: linhanna@cox.net
Homepage Title:
Homepage URL:
Referred By: E-Mail
Location:
Comments: This makes me very sad, my sister is dying from CJD. I try to read about CJD, but cry every time trying to read about it.


Friday 07/21/2006 7:05:24pm
Name: ainee
E-Mail:
Homepage Title:
Homepage URL:
Referred By: Search Engine
Location: Australia
Comments: marcotte, Tell your mother not to give up. I was never diagnosed as with CJD, but suffered similar horrific neurological symptoms. I read about a treatment for similar symptoms. I took 250 mgs Vitamin B1 3 or 4 times a day, which suppressed the symptoms. I found that because of my weight - 14 st. or 87 kgs - I had to raise the dose to 500 mgs. 3 or 4 times a day and experimented for 18 months before the symptoms started to reverse and now am reasonably well most of the time. I still take my treatment 3 times a day to stay as well as I can be.
Don't take VB1 if on pain relief.
I also found 3000mgs Vitamin C 3 times a day, suppressed my symptoms. It was a case of experimentation to find the right dose amount for my body weight. I was very ill. I sweated, had vibrations in my body, cramps, spasms, facial grimaces etc, but as time went on, these symptoms became less and less. I felt slight twinges in my spine, with each twinge, the symptoms became less. I hope this helps. VB1 and VC are water soluble vitamins.
God Bless
ainee.


Sunday 07/16/2006 10:03:31am
Name: marcotte
E-Mail: dmarc721@cox.net
Homepage Title: what to do...
Homepage URL:
Referred By: Just Surfed In
Location: r.i.
Comments: Diagnosed 6/18/06...sporadic cjd...symptoms include mild dementia...coordination and ambulation difficulties. MD feels we are at an early stage and symptoms will increase and worsen. My mother has deferred any further medical assistance and prefers death here at home. My family is truly devastated. She is only 65, vibrant, beautiful. What to do?


Sunday 07/02/2006 3:28:06am
Name: ainee
E-Mail:
Homepage Title:
Homepage URL:
Referred By: Search Engine
Location:
Comments: I wonder if others who suffer neurological symptoms of any sort - including those who are diagnosed as with CJD - have knotted up back muscles.
An Osteopath in 2001 said that my "back muscles are all knotted up." No other test has found what could be the cause of my symptoms, similar to CJD. I've found many who have neurological symptoms, cannot find a cause either - many after taking medication for years, still have the symptoms.
The treatment I experimented with, suppressed and after 18 months of research, experimentation, trial and error, my symptoms started to reverse, now I have reasonably good health with only a few symptoms which I can live with.
I wonder do others who suffer neurological symptoms also have "knotted up back muscles." I've had many pathology tests, MRI's, CT scans, nothing showed any damage to my spine - yet the Osteopath felt along my spine and could feel my knotted up muscles. Perhaps this is the cause of neurological symptoms for which a cause cannot be found - including CJD. The treatment of 250mgs Vitamin B1 3 or 4 times a day, suppressed my symptoms. I rose the dose to 500mgs 3 times a day and eventually my symptoms reversed. Do NOT take VB1 if on pain relief.
ainee.



http://htmlgear.tripod.com/gw/guest/control.guest?u=stacy91434&a=view&i=1&r=http://www.google.com/search%3fnum=30&hl=en&lr=&edition=us&q=cjd+ainee&btnG=Search



> you need mental help and a first grade education for

> starters, and a lesson in how not to come to a place where

> family members are dying and be an idiot. why don't you go

> to a funeral and crap in the grave while you are at it?



ainee and delky need to be sealed in the same coffin for a while with a victim of cjd for there continued ignorance and exploit of there buffoonery.

why the moderators of this board put up with there crap is beyond me. the both of them discredit the board, it's purpose and belittles every family and there loved one that are dealing with CJD.

are the moderators even listening to our pleas here, or do they even care?

someone is capable of deleting there crap, and banning them permenantly, if they want to here.

it should have been done long ago. they are disgusting.



http://disc.server.com/discussion.cgi?disc=7498;article=3039;title=CJD%20 Voice%20Discussion%20Group



http://disc.server.com/discussion.cgi?disc=7498;article=3175;title=CJD%20 Voice%20Discussion%20Group;pagemark=40



http://disc.server.com/discussion.cgi?disc=7498;article=3170;title=CJD%20 Voice%20Discussion%20Group;pagemark=40



http://disc.server.com/discussion.cgi?disc=7498;article=3143;title=CJD%20 Voice%20Discussion%20Group;pagemark=40



ainee
MY STORY MAY GIVE HOPE
Fri Jun 30, 2006 03:47
203.220.147.101


http://disc.server.com/discussion.cgi?disc=7498;article=3121;title=CJD%20 Voice%20Discussion%20Group;pagemark=40


http://disc.server.com/discussion.cgi?disc=7498;article=3131;title=CJD%20 Voice%20Discussion%20Group;pagemark=40


http://disc.server.com/discussion.cgi?disc=7498;article=3288;title=CJD%20 Voice%20Discussion%20Group


http://disc.server.com/discussion.cgi?disc=7498;article=3175;title=CJD%20 Voice%20Discussion%20Group;pagemark=40


http://disc.server.com/discussion.cgi?disc=7498;article=3170;title=CJD%20 Voice%20Discussion%20Group;pagemark=40


http://disc.server.com/discussion.cgi?id=7498;pagemark=40


http://disc.server.com/discussion.cgi?disc=7498;article=2864;title=CJD%20 Voice%20Discussion%20Group;pagemark=140

[ainee]

G'day flatfish - and thanks again for bringing all this to the attention of those who perhaps have missed it the first time - because I haven't any computer knowledge as how to paste and copy. Your work has certainly helped bring my information and research full circle again. Hope someone eventually benifits from it.
Have a nice day.
ainee.

[flatfish]

FDA NVCJD BLOOD LATEST RECALLS

PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0576-7;
b) Red Blood Cells, Recall # B-0577-7;
c) Fresh Frozen Plasma, Recall # B-0578-7;
d) Recovered Plasma, Recall # B-0579-7
CODE
a) Units: 4588939, 4685381,4800041, 4892978, 4882799,
4883439, 4956157;
b) Unit: 4662465;
c) Units: 4800041, 4883439;
d) Units: 4588939, 4662465, 4685381, 4800041, 4892978,
4882799, 4956157
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on March 11, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
OK, MS, MI, CA, and Switzerland
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0580-7;
b) Recovered Plasma, Recall # B-0581-7
CODE
a) and b) Unit: 5346932
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on October 27, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland

______________________________
PRODUCT
a) Red Blood Cells Leukocytes, Recall # B-0582-7;
b) Recovered Plasma, Recall # B-0583-7
CODE
a) and b) Unit: 5208304
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on April 20, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased riskfor variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland

______________________________
PRODUCT
Source Plasma, Recall # B-0585-7
CODE
Units: 02JWIB9722, 02JWIC0263, 02JWIC0607, 02JWIC4253, 02JWIC4904, 02JWIC5216, 02JWID2018, 02JWID2958, 02JWID3310, 02JWID8505, 02JWID8842, 02JWID9390, 02JWID9844, 02JWIE0468, 02JWIE0836, 02JWIE1435, 02JWIE1812, 02JWIE2609, 02JWIE3289, 02JWIE3887, 02JWIE4309, 02JWIE4818, 02JWIE5277, 02JWIE5825, 03JWIA0857, 03JWIA1249, 03JWIA1850, 03JWIA2192, 03JWIA2825, 03JWIA3180, 03JWIA3724, 03JWIA4092, 03JWIA4691, 03JWIA5042, 03JWIA5586, 02JWIC1157, 02JWIC1458, 02JWIC2095, 02JWIC2551, 02JWIC3031, 02JWIC3491, 02JWIC3975, 02JWIC6689, 02JWIC7051, 02JWIC7609, 02JWIC7898, 02JWIC8547, 02JWIC8906, 02JWIC9494, 02JWIC9793, 02JWID0630, 02JWID1144, 02JWID1592, 02JWID3884, 02JWID4247, 02JWID4827, 02JWID5189, 02JWID5713, 02JWID6578, 02JWID6926, 02JWID7624, 02JWID7970
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Janesville, WI, by fax on April 7, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
62 units
DISTRIBUTION
MI and Austria

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PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0586-7;
b) Recovered Plasma, Recall # B-0587-7
CODE
a) and b) Unit: 4499508
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on February 27, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0644-7;
b) Recovered Plasma, Recall # B-0645-7
CODE
a) and b) Units: 5219381, 4759725
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on December 3, 2005 or by electronic notification on December 4, 2005. 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
4 units
DISTRIBUTION
OK, VA, and Switzerland

______________________________


END OF ENFORCEMENT REPORT FOR JANUARY 17, 2007

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http://www.fda.gov/bbs/topics/enforce/2007/ENF00987.html


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