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NCBA, R-CALF, COOL, USDA (No Politics!)
Scientists warn of high rate of vCJD infection via blood
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<blockquote data-quote="flounder" data-source="post: 202202" data-attributes="member: 3519"><p>TURNTHATCOWLOOSEMAW WRITES;</p><p></p><p>BLAH BLAH BLAH BLAH BLAH shutup with your bull crap rhetoric already noone wants to hear it. Your idiocy obviously knows no bounds. </p><p></p><p>_________________</p><p>I saw this on a church sign once it read.... GIT-R-Done Fer God. </p><p>=========================================</p><p></p><p>sadly maw, this is not rhetoric, it is real, and for the life of me, as a producer of beef in some way i assume, i cannot believe you think it is rhetoric. this is exactly what has been wrong here in the USA. it's like dumb and dumber raising beef here.</p><p>but i suppose this will get deleted as well, since i have no right of opinion here, even if they are facts. do any of you not go to the hospital and get blood and or medical procedures done?</p><p></p><p>no maw, i am not going anywhere unless i am banned, and i am not giving them any reason to ban me. you can slam me all you want, call me whatever you want, fact is, i am a consumer of your products, and have just as much right in this debate as anyone here. in fact, there are some writing me from this site thanking me for the info. not everyone has there head in the sand. it's folks like you that are killing your industry. </p><p></p><p>now, i will just give you (well, not you, you don't seem to care), but i will give others a taste of what i speak of right here in the USA. now this is just 2006 and just a taste of it, i dont want to use up too much valuable space here;</p><p></p><p></p><p>RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I</p><p></p><p>_______________________________</p><p>PRODUCT</p><p>Human Tissue for Transplantation, Recall # B-0432-6:</p><p>a) Tricortical Wedge (R) 1.5 x 2.5 cm,</p><p>Freeze Dried Irradiated;</p><p>b) Tricortical Wedge ( L ) 1.7 x 3.0 cm,</p><p>Fresh Frozen Irradiated;</p><p>c) Cancellous Crushed 60.0 cc, Freeze Dried,</p><p>Irradiated;</p><p>d) Cancellous Crushed 30.0 cc Freeze Dried,</p><p>Irradiated;</p><p>e) Achilles Tendon OA ( R ) Fresh Frozen</p><p>Irradiated;</p><p>f) Achilles Tendon OA ( L ) Fresh Frozen</p><p>Irradiated;</p><p>g) Lumbar;</p><p>h) Cancellous Crushed 30.0 cc Fresh Frozen,</p><p>Irradiated</p><p>CODE</p><p>a) Tissue 04091-002;</p><p>b) Tissue 04113-003;</p><p>c) Tissues 04091-008, 04101-008, 04103-002,</p><p>04103-003, 04105-003;</p><p>d) Tissues 04091-005, 04091-006, 04091-007,</p><p>04101-006, 04101-007, 04102-004, 04102-005,</p><p>04104-003, 04104-004, 04104-005, 04105-002,</p><p>04109-003, 04109-004, 04120-004, 04124-003,</p><p>04124-004, 04138-002, 04138-003, 04140-002,</p><p>04143-002, 04143-003, 04146-001, 04152-001;</p><p>e) Tissues 04101-003, 04123-004;</p><p>f) Tissues 04101-004, 04123-003;</p><p>g) Tissues 03049-001, 03051-001, 04091-001,</p><p>04102-001, 04103-001, 04104-001, 04105-001,</p><p>04106-001, 04107-001, 04108-001, 04109-001,</p><p>04113-001, 04120-001, 04122-001, 04123-001,</p><p>04124-001;</p><p>h) Tissue 04108-002</p><p>RECALLING FIRM/MANUFACTURER</p><p>Recalling Firm: Central Texas Regional Blood & Tissue Center, Austin, TX, by telephone on October 4, 2005, and by letter dated October 11, 2005.</p><p>Manufacturer: Biomedical Tissue Services, Fort Lee, NJ, firm initiated recall is ongoing.</p><p>REASON</p><p>Human tissues, procured from donors without adequate donor eligibility determinations, were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>51 allografts</p><p>DISTRIBUTION</p><p>TX and CO</p><p></p><p>PRODUCT</p><p>Human Corneal Tissues for Transplantation, Recall # B-0380-6</p><p>CODE</p><p>Tissues: CI044108 OD and CI044108 OS</p><p>RECALLING FIRM/MANUFACTURER</p><p>Michigan Eye Bank, Ann Arbor, MI, by letter dated November 22, 2005, and by facsimile dated November 28, 2005. Firm initiated recall is complete.</p><p>REASON</p><p>Human Corneas, collected from an ineligible donor, were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>2 tissues</p><p>DISTRIBUTION</p><p>MI, CA and Germany</p><p></p><p>_______________________________</p><p></p><p>PRODUCT</p><p>a) Red Blood Cells Leukocytes Reduced,</p><p>Recall # B-0617-6;</p><p>b) Red Blood Cells (Apheresis) Leukocytes Reduced</p><p>(distributed as split product), Recall # B-0618-6;</p><p>c) Platelets Leukocytes Reduced, Recall # B-0619-6;</p><p>d) Fresh Frozen Plasma, Recall # B-0620-6;</p><p>e) Cryoprecipitated AHF, Recall # B-0621-6;</p><p>f) Plasma Cryoprecipitate Reduced, Recall # B-0622-6;</p><p>g) Recovered Plasma, Recall # B-0623-6</p><p>CODE</p><p>a) Unit numbers: 1136792, 1040212, 1011245;</p><p>b) Unit numbers: 1048247-1, 1048247-2;</p><p>c) Unit numbers: 1040212, 1011245;</p><p>d) Unit number: 1136792;</p><p>e) Unit numbers: 1040212, 1011245;</p><p>f) Unit number: 1040212;</p><p>g) Unit number: 1011245</p><p>RECALLING FIRM/MANUFACTURER</p><p>Hoxworth Blood Center, Cincinnati, OH, by letter dated September 6, 2005. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>12 units</p><p>DISTRIBUTION</p><p>OH and FL</p><p></p><p>_______________________________</p><p></p><p>END OF ENFORCEMENT REPORT FOR MARCH 1, 2006</p><p></p><p>###</p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00941.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00941.html</a></p><p></p><p></p><p></p><p>PRODUCT</p><p>Recovered Plasma, Recall # B-0643-6</p><p>CODE</p><p>Unit numbers: R170537, R165863, and R158308</p><p>RECALLING FIRM/MANUFACTURER</p><p>Puget Sound Blood Center, Seattle, WA, by facsimile on October 7, 2003. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>3 units</p><p>DISTRIBUTION</p><p>Austria</p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR FEBRUARY 22, 2006</p><p></p><p>###</p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00940.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00940.html</a></p><p></p><p></p><p>PRODUCT</p><p>a) Product is 1.0 cc Regenaform® RT. SINGLE PATIENT</p><p>USE ONLY. Recall # Z-0481-06;</p><p>b) OPTEFORM Allografts of varying sizes. SINGLE PATIENT</p><p>USE ONLY. Recall # Z-0482-06;</p><p>c) Product is OPTEFORM Allograft Paste of varying sizes.</p><p>SINGLE PATIENT USE ONLY. Recall # Z-0483-06;</p><p>d) OPTEFORM® RT Moldable Allograft of varying sizes.</p><p>SINGLE PATIENT USE ONLY. Recall # Z-0484-06;</p><p>e) Osteofil + RT Allograft Paste in varying sizes.</p><p>SINGLE PATIENT USE ONLY. Recall # Z-0485-06;</p><p>f) Osteofil Allograft Paste (Bio) of varying sizes.</p><p>SINGLE PATIENT USE ONLY. Recall # Z-0486-06;</p><p>g) Osteofil IC Syringeable of varying sizes. SINGLE</p><p>PATIENT USE ONLY. Recall # 0487-06;</p><p>h) Osteofil ICM Moldable Strip of varying sizes.</p><p>SINGLE PATIENT USE ONLY. Recall # Z-0488-06;</p><p>i) Osteofil RT, ICM Allograft Paste of varying sizes.</p><p>SINGLE PATIENT USE ONLY. Recall # Z-0489-06;</p><p>j) OSTEOFIL® DBM Paste of varying sizes. SINGLE</p><p>PATIENT USE ONLY. Recall # Z-0490-06;</p><p>k) OsteoPack 3 FZ 22cc. SINGLE PATIENT USE ONLY.</p><p>Recall # Z-0491-06;</p><p>l) Regenafil IC. SINGLE PATIENT USE ONLY.</p><p>Recall # Z-0492-06;</p><p>m) REGENAFORM RT Allograft Paste, 1cc. SINGLE</p><p>PATIENT USE ONLY. Recall # Z-0493-06;</p><p>n) Product is REGENAFORM® Allograft Moldable Blocks,</p><p>of varying sizes. SINGLE PATIENT USE ONLY.</p><p>Recall # Z-0494-06;</p><p>o) Product is RTI Allograft Paste of varying sizes.</p><p>SINGLE PATIENT USE ONLY. Recall # Z-0495-06;</p><p>p) Product is REGENAFIL® Allograft Paste, Syringe,</p><p>0.5cc. SINGLE PATIENT USE ONLY. Recall # 0496-06;</p><p>q) Product is 1.0cc flowable paste from donor</p><p>approved for distribution in Italy. SINGLE</p><p>PATIENT USE ONLY. Recall # Z-0497-06;</p><p>r) Product is OPTEFIL Allograft Paste of varying</p><p>sizes. SINGLE PATIENT USE ONLY. Recall</p><p># Z-0498-06;</p><p>s) Product is OPTEFIL Allograft Paste, Syringe</p><p>of varying sizes. SINGLE PATIENT USE ONLY.</p><p>Recall # Z-0499-06;</p><p>t) Product is OPTEFORM® Allograft Full Disc,</p><p>5 x 90mm, 32cc, Frozen. SINGLE PATIENT USE</p><p>ONLY, Recall # Z-0500-06;</p><p>u) Product is 2.0 cc Opteform® RT. SINGLE</p><p>PATIENT USE ONLY. Recall # Z-0501-06</p><p>CODE</p><p>2879130 2879131 2879132 2879133 2879134 2879135 2879136 </p><p></p><p>snip...too long and too many recalls to list here...tss</p><p></p><p>RECALLING FIRM/MANUFACTURER</p><p>Regeneration Technologies, Inc., Alachua, FL, by letter on October 14, 2005. Firm initiated recall is ongoing.</p><p>REASON</p><p>The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>5,320</p><p>DISTRIBUTION</p><p>Nationwide and Internationally</p><p></p><p>END OF ENFORCEMENT REPORT FOR FEBRUARY 15, 2006</p><p></p><p>###</p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00939.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00939.html</a></p><p></p><p></p><p>_______________________________</p><p>PRODUCT</p><p>Source Plasma, Recall # B-0584-6</p><p>CODE</p><p>Units VL53767, ZZ031076, ZZ030881, ZZ03046, VL151413, VL151144, VL50837</p><p>RECALLING FIRM/MANUFACTURER</p><p>BioLife Plasma Services LP, Shreveport, LA, by facsimile dated October 6, 2003. Firm initiated recall is complete.</p><p>REASON</p><p>Source Plasma, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>7 units</p><p>DISTRIBUTION</p><p>NC</p><p></p><p>END OF ENFORCEMENT REPORT FOR FEBRUARY 1, 2006</p><p></p><p>###</p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00937.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00937.html</a></p><p></p><p></p><p>_______________________________</p><p>PRODUCT</p><p>Red Blood Cells, Recall # B-0552-6</p><p>CODE</p><p>Unit number: 4426304</p><p>RECALLING FIRM/MANUFACTURER</p><p>Florida's Blood Center, Inc., St. Petersburg, FL, by facsimile on July 8, 2005. Firm initiated recall is complete.</p><p>REASON</p><p>Blood product, collected from a donor who may have been at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>1 unit</p><p>DISTRIBUTION</p><p>FL</p><p></p><p>END OF ENFORCEMENT REPORT FOR JANUARY 25, 2006</p><p></p><p>###</p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00936.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00936.html</a></p><p></p><p></p><p>RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I</p><p></p><p>_______________________________</p><p>PRODUCT</p><p>Human Tissue for Transplantation, Recall # B-0322-6</p><p>a) Alloquent CC Allograft (8, 9 & 10 mm);</p><p>b) Achilles Tendon;</p><p>c) Cancellous Bone 4-10 mm (15 & 30 cc);</p><p>d) Patella Tendon-Hemi;</p><p>e) Iliac Crest Wedge (14-17mm, 11-13mm,</p><p><10mm, and 18+mm);</p><p>f) Tibialis Tendon</p><p>CODE</p><p>a) Code: BS30-4008, BS30-4009, BS30-4010;</p><p>b) Code: LATM;</p><p>c) Code: LCISM & LCIPM;</p><p>d) Code: LTTM;</p><p>e) Code: LIWXLM, LIWLM, LIWMM, LIWSM;</p><p>f) Code: LTTM</p><p>RECALLING FIRM/MANUFACTURER</p><p>Recalling Firm: Lost Mountain Tissue Bank, Kennesaw, GA, by letters dated October 12, and October 21, 2005.</p><p>Manufacturer: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firm initiated recall is ongoing.</p><p>REASON</p><p>Human tissues, procured from donors without adequate donor eligibility determinations, were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>283 tissues</p><p>DISTRIBUTION</p><p>Nationwide and Turkey</p><p></p><p>_______________________________</p><p>PRODUCT</p><p>PUROS Allograft Bone;</p><p>Suspend Tutoplast Processed Fascia Lata,</p><p>Recall # B-0375-6</p><p>CODE</p><p>a) U00000000045293 U00000000045294 U00000000045295 </p><p></p><p></p><p>snip...</p><p></p><p>b) BM03L11421A012031504 BM03L11821A012031504 </p><p></p><p>snip...again, too many recalls of this product to list here...tss</p><p></p><p>RECALLING FIRM/MANUFACTURER</p><p>Recalling Firm: Tutogen Medical, Inc., Alachua, FL, by telephone, facsimile and letter on October 14, 2005 and by letter dated October 24, 2005.</p><p>Responsible Firm: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firm initiated recall is ongoing.</p><p>REASON</p><p>Human Tissues, procured from donors without adequate donor eligibility determinations, were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>a) 5,676 allografts;</p><p>b) 48 allografts</p><p>DISTRIBUTION</p><p>Nationwide, and Canada</p><p></p><p></p><p>_______________________________</p><p>PRODUCT</p><p>a) Red Blood Cells, Leukocytes</p><p>Reduced, Recall # B-0492-6;</p><p>b) Recovered Plasma, Recall # B-0497-6</p><p>CODE</p><p>a) and b) Unit number: 4101212</p><p>RECALLING FIRM/MANUFACTURER</p><p>Northwest Florida Blood Center, Inc., Pensacola, FL, by telephone and facsimile on March 7, 2003. Firm initiated recall is complete.</p><p>REASON</p><p>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 (nvCJD), were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>2 units</p><p>DISTRIBUTION</p><p>FL</p><p></p><p>_______________________________</p><p></p><p>END OF ENFORCEMENT REPORT FOR JANUARY 18, 2006</p><p></p><p>###</p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00935.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00935.html</a></p><p></p><p></p><p>PRODUCT</p><p>Source Plasma, Recall # B-0391-6</p><p>CODE</p><p>Unit number: 7030260750</p><p>RECALLING FIRM/MANUFACTURER</p><p>ZLB Bioplasma, Inc., San Antonio, TX, by facsimile and telephone on September 29, 2003. Firm initiated recall is complete.</p><p>REASON</p><p>Blood product, which was collected from a donor who was deferred due to risk factors associated with variant Creutzfeldt-Jakob disease (vCJD) travel, was distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>1 unit</p><p>DISTRIBUTION</p><p>FL</p><p></p><p>_______________________________</p><p></p><p>______________________________</p><p>PRODUCT</p><p>a) Red Blood Cells, Leukocytes Reduced</p><p>Recall # B-0456-6;</p><p>b) Recovered Plasma, Recall # B-0457-6</p><p>CODE</p><p>a) Unit number: 06FR39967;</p><p>b) Unit numbers: 06FR37676, 06FR39967</p><p>RECALLING FIRM/MANUFACTURER</p><p>American National Red Cross, Southern California Region, Pomona, California, by telephone on June 2, 2002, and by letter dated, June 20, 2002, and by facsimile transmission dated June 19, 2002. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, collected from a donor who was at increased risk of variant Creutzfeldt-Jakob Disease (vCJD), were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>3 units</p><p>DISTRIBUTION</p><p>CA and Switzerland</p><p></p><p>_______________________________</p><p></p><p>END OF ENFORCEMENT REPORT FOR JANUARY 4, 2006</p><p></p><p>###</p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00933.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00933.html</a></p><p></p><p></p><p>THE END...</p><p></p><p>I LOVE THE DIXIE CHICKS AND SO DOES GOD, THEY WERE RIGHT ALL ALONG...TSS</p></blockquote><p></p>
[QUOTE="flounder, post: 202202, member: 3519"] TURNTHATCOWLOOSEMAW WRITES; BLAH BLAH BLAH BLAH BLAH shutup with your bull crap rhetoric already noone wants to hear it. Your idiocy obviously knows no bounds. _________________ I saw this on a church sign once it read.... GIT-R-Done Fer God. ========================================= sadly maw, this is not rhetoric, it is real, and for the life of me, as a producer of beef in some way i assume, i cannot believe you think it is rhetoric. this is exactly what has been wrong here in the USA. it's like dumb and dumber raising beef here. but i suppose this will get deleted as well, since i have no right of opinion here, even if they are facts. do any of you not go to the hospital and get blood and or medical procedures done? no maw, i am not going anywhere unless i am banned, and i am not giving them any reason to ban me. you can slam me all you want, call me whatever you want, fact is, i am a consumer of your products, and have just as much right in this debate as anyone here. in fact, there are some writing me from this site thanking me for the info. not everyone has there head in the sand. it's folks like you that are killing your industry. now, i will just give you (well, not you, you don't seem to care), but i will give others a taste of what i speak of right here in the USA. now this is just 2006 and just a taste of it, i dont want to use up too much valuable space here; RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I _______________________________ PRODUCT Human Tissue for Transplantation, Recall # B-0432-6: a) Tricortical Wedge (R) 1.5 x 2.5 cm, Freeze Dried Irradiated; b) Tricortical Wedge ( L ) 1.7 x 3.0 cm, Fresh Frozen Irradiated; c) Cancellous Crushed 60.0 cc, Freeze Dried, Irradiated; d) Cancellous Crushed 30.0 cc Freeze Dried, Irradiated; e) Achilles Tendon OA ( R ) Fresh Frozen Irradiated; f) Achilles Tendon OA ( L ) Fresh Frozen Irradiated; g) Lumbar; h) Cancellous Crushed 30.0 cc Fresh Frozen, Irradiated CODE a) Tissue 04091-002; b) Tissue 04113-003; c) Tissues 04091-008, 04101-008, 04103-002, 04103-003, 04105-003; d) Tissues 04091-005, 04091-006, 04091-007, 04101-006, 04101-007, 04102-004, 04102-005, 04104-003, 04104-004, 04104-005, 04105-002, 04109-003, 04109-004, 04120-004, 04124-003, 04124-004, 04138-002, 04138-003, 04140-002, 04143-002, 04143-003, 04146-001, 04152-001; e) Tissues 04101-003, 04123-004; f) Tissues 04101-004, 04123-003; g) Tissues 03049-001, 03051-001, 04091-001, 04102-001, 04103-001, 04104-001, 04105-001, 04106-001, 04107-001, 04108-001, 04109-001, 04113-001, 04120-001, 04122-001, 04123-001, 04124-001; h) Tissue 04108-002 RECALLING FIRM/MANUFACTURER Recalling Firm: Central Texas Regional Blood & Tissue Center, Austin, TX, by telephone on October 4, 2005, and by letter dated October 11, 2005. Manufacturer: Biomedical Tissue Services, 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 51 allografts DISTRIBUTION TX and CO PRODUCT Human Corneal Tissues for Transplantation, Recall # B-0380-6 CODE Tissues: CI044108 OD and CI044108 OS RECALLING FIRM/MANUFACTURER Michigan Eye Bank, Ann Arbor, MI, by letter dated November 22, 2005, and by facsimile dated November 28, 2005. Firm initiated recall is complete. REASON Human Corneas, collected from an ineligible donor, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 tissues DISTRIBUTION MI, CA and Germany _______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-0617-6; b) Red Blood Cells (Apheresis) Leukocytes Reduced (distributed as split product), Recall # B-0618-6; c) Platelets Leukocytes Reduced, Recall # B-0619-6; d) Fresh Frozen Plasma, Recall # B-0620-6; e) Cryoprecipitated AHF, Recall # B-0621-6; f) Plasma Cryoprecipitate Reduced, Recall # B-0622-6; g) Recovered Plasma, Recall # B-0623-6 CODE a) Unit numbers: 1136792, 1040212, 1011245; b) Unit numbers: 1048247-1, 1048247-2; c) Unit numbers: 1040212, 1011245; d) Unit number: 1136792; e) Unit numbers: 1040212, 1011245; f) Unit number: 1040212; g) Unit number: 1011245 RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, OH, by letter dated September 6, 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 12 units DISTRIBUTION OH and FL _______________________________ END OF ENFORCEMENT REPORT FOR MARCH 1, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00941.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00941.html[/url] PRODUCT Recovered Plasma, Recall # B-0643-6 CODE Unit numbers: R170537, R165863, and R158308 RECALLING FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA, by facsimile on October 7, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION Austria END OF ENFORCEMENT REPORT FOR FEBRUARY 22, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00940.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00940.html[/url] PRODUCT a) Product is 1.0 cc Regenaform® RT. SINGLE PATIENT USE ONLY. Recall # Z-0481-06; b) OPTEFORM Allografts of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0482-06; c) Product is OPTEFORM Allograft Paste of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0483-06; d) OPTEFORM® RT Moldable Allograft of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0484-06; e) Osteofil + RT Allograft Paste in varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0485-06; f) Osteofil Allograft Paste (Bio) of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0486-06; g) Osteofil IC Syringeable of varying sizes. SINGLE PATIENT USE ONLY. Recall # 0487-06; h) Osteofil ICM Moldable Strip of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0488-06; i) Osteofil RT, ICM Allograft Paste of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0489-06; j) OSTEOFIL® DBM Paste of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0490-06; k) OsteoPack 3 FZ 22cc. SINGLE PATIENT USE ONLY. Recall # Z-0491-06; l) Regenafil IC. SINGLE PATIENT USE ONLY. Recall # Z-0492-06; m) REGENAFORM RT Allograft Paste, 1cc. SINGLE PATIENT USE ONLY. Recall # Z-0493-06; n) Product is REGENAFORM® Allograft Moldable Blocks, of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0494-06; o) Product is RTI Allograft Paste of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0495-06; p) Product is REGENAFIL® Allograft Paste, Syringe, 0.5cc. SINGLE PATIENT USE ONLY. Recall # 0496-06; q) Product is 1.0cc flowable paste from donor approved for distribution in Italy. SINGLE PATIENT USE ONLY. Recall # Z-0497-06; r) Product is OPTEFIL Allograft Paste of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0498-06; s) Product is OPTEFIL Allograft Paste, Syringe of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0499-06; t) Product is OPTEFORM® Allograft Full Disc, 5 x 90mm, 32cc, Frozen. SINGLE PATIENT USE ONLY, Recall # Z-0500-06; u) Product is 2.0 cc Opteform® RT. SINGLE PATIENT USE ONLY. Recall # Z-0501-06 CODE 2879130 2879131 2879132 2879133 2879134 2879135 2879136 snip...too long and too many recalls to list here...tss RECALLING FIRM/MANUFACTURER Regeneration Technologies, Inc., Alachua, FL, by letter on October 14, 2005. Firm initiated recall is ongoing. REASON The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested. VOLUME OF PRODUCT IN COMMERCE 5,320 DISTRIBUTION Nationwide and Internationally END OF ENFORCEMENT REPORT FOR FEBRUARY 15, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00939.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00939.html[/url] _______________________________ PRODUCT Source Plasma, Recall # B-0584-6 CODE Units VL53767, ZZ031076, ZZ030881, ZZ03046, VL151413, VL151144, VL50837 RECALLING FIRM/MANUFACTURER BioLife Plasma Services LP, Shreveport, LA, by facsimile dated October 6, 2003. Firm initiated recall is complete. REASON Source Plasma, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 7 units DISTRIBUTION NC END OF ENFORCEMENT REPORT FOR FEBRUARY 1, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00937.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00937.html[/url] _______________________________ PRODUCT Red Blood Cells, Recall # B-0552-6 CODE Unit number: 4426304 RECALLING FIRM/MANUFACTURER Florida's Blood Center, Inc., St. Petersburg, FL, by facsimile on July 8, 2005. Firm initiated recall is complete. REASON Blood product, collected from a donor who may have been at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION FL END OF ENFORCEMENT REPORT FOR JANUARY 25, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00936.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00936.html[/url] RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I _______________________________ 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 snip... b) BM03L11421A012031504 BM03L11821A012031504 snip...again, too many recalls of this product to list here...tss 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 _______________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0492-6; b) Recovered Plasma, Recall # B-0497-6 CODE a) and b) Unit number: 4101212 RECALLING FIRM/MANUFACTURER Northwest Florida Blood Center, Inc., Pensacola, FL, by telephone and facsimile on March 7, 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 variant Creutzfeldt-Jakob Disease (nvCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION FL _______________________________ END OF ENFORCEMENT REPORT FOR JANUARY 18, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00935.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00935.html[/url] PRODUCT Source Plasma, Recall # B-0391-6 CODE Unit number: 7030260750 RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., San Antonio, TX, by facsimile and telephone on September 29, 2003. Firm initiated recall is complete. REASON Blood product, which was collected from a donor who was deferred due to risk factors associated with variant Creutzfeldt-Jakob disease (vCJD) travel, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION FL _______________________________ ______________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced Recall # B-0456-6; b) Recovered Plasma, Recall # B-0457-6 CODE a) Unit number: 06FR39967; b) Unit numbers: 06FR37676, 06FR39967 RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Pomona, California, by telephone on June 2, 2002, and by letter dated, June 20, 2002, and by facsimile transmission dated June 19, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who was at increased risk of variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION CA and Switzerland _______________________________ END OF ENFORCEMENT REPORT FOR JANUARY 4, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00933.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00933.html[/url] THE END... I LOVE THE DIXIE CHICKS AND SO DOES GOD, THEY WERE RIGHT ALL ALONG...TSS [/QUOTE]
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Scientists warn of high rate of vCJD infection via blood
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