Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

rule

January 17, 2007
07-03

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS - CLASS I

______________________________
PRODUCT
Classic Oatmeal Big Batch Homestyle Cookies, Archway, 13.75 ounce packages, Recall # F-088-7
CODE
Date code: 'Best Before Jan 11 07 AX'.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Archway & Mothers Cookie Co., Ashland, OH, by telephone beginning on October 26, 2006, e-mail on October 27, 2006, press release on November 3, 2006, and by letter on November 6, 2006.
Manufacturer: Archway & Mothers Cookie Co., Ashland,OH. Firm initiated recall is ongoing.
REASON
The cookies contain tree nuts (walnuts), but the product label indicates only that the products may contain traces of peanuts and tree nuts.
VOLUME OF PRODUCT IN COMMERCE
299 cases/34/13.75 ounce packages per case
DISTRIBUTION
States East of the Mississippi River

______________________________
PRODUCT
Llano and Nature's Partner brands Fresh Mexican Cantaloupes, packed in cardboard boxes, labeled in part as Llano and Nature's Partner Cantaloupes, Recall # F-089-7
CODE
Pending
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rio Vista Ltd., Rio Rico, AZ, by telephone on November 6, 2006, press release on November 17, 2006, and by letter on November 18, 2006.
Manufacturer: S.P.R. De. R.I. Santaine, Sonora, Mexico. Firm initiated recall is ongoing.
REASON
Sample analysis by the FDA found the product contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
62,640 cartons
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
Crunchmaster Toasted Sesame Crunchy Oven Baked Rice Crackers; Net Wt.3.5 oz. plastic tray with plastic film wrapper; UPC 8 53358 00045 7. The affected packages of toasted sesame crackers were sold exclusively at Costco Stores in a cardboard sleeve 6-pack containing 3 packages of toasted sesame crackers and 3 packages of artisan four cheese crackers. The 6-pack sleeve is labeled as Crunchmaster Rice Crackers *** Artisan Four Cheese *** Toasted Sesame *** 6 Pack *** New Wt 21 oz. (1 lb 5 oz) (595 g) *** UPC 8 53358 00046 4, Recall # F-090-7
Product Public Reason for Recall:
CODE
Best Before JUN 08 2007 B
RECALLING FIRM/MANUFACTURER
TH Foods Inc., Loves Park, IL, by telephone, fax, e-mail and letter on November 28, 2006, and by press release on November 30, 2006. Firm initiated recall is ongoing.
REASON
Some of the packages of Crunchmaster Toasted Sesame Rice Crackers actually contain Crunchmaster Artisan Four Cheese Rice Crackers which contain milk products that are not declared on the sesame cracker ingredients statement.
VOLUME OF PRODUCT IN COMMERCE
2,680 packages in 893 6-packs
DISTRIBUTION
TX and WA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0525-7;
b) Platelets, Recall # B-0526-7
CODE
a) and b) Unit KT10444
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on July 15, 2006. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Enterococcus faecalis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0537-7
CODE
Unit 5466120
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone and facsimile on August 29, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of leukemia, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0538-7
CODE
Unit 033GW32048
RECALLING FIRM/MANUFACTURER
American National Red Cross, Connecticut Region, Farmington, CT, by telephone on August 4, 2006 and by letter dated August 8, 2006. Firm initiated recall is complete.
REASON
Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CT

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0553-7
CODE
Unit 5776608
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone on December 6, 2005. Firm initiated recall is complete.
REASON
Problem: Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0556-7
CODE
Unit 5449602
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone on July 8, 2005 and by facsimile on November 11, 2005. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0563-7
CODE
Unit: 2049665
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by fax on October 25, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0564-7
CODE
Unit: 2232609
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by telephone and fax on June 15, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0565-7
CODE
Unit: 2225579
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by fax on June 15, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0566-7
CODE
Units: 2057429, 2705728, 2046688
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by fax on May 3, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TN

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0567-7
CODE
Unit: 5243510
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on May 6, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0569-7
CODE
Units: 5241017, 4999508
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on March 18, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and FL

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0573-7;
b) Platelets, Recall # B-0574-7;
c) Fresh Frozen Plasma, Recall # B-0575-7
CODE
a), b), and c) Unit: 4994918
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on December 14, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of lymphoma, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OK and TX

______________________________
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

______________________________
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

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0617-7
CODE
Unit: 2073589 (Part A)
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on February 9, 2006 and by facsimile on February 13, 2006. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0620-7
CODE
Units: 2070144 (Parts A & B)
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on November 29, 2005 and by facsimile on November 30, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with coagulase negative Staphylococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0621-7
CODE
Unit: 2069807
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on November 22, 2005 and by facsimile on January 18,, 2006. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with coagulase negative Staphylococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0622-7
CODE
Units: 2072153 (Parts A & B)
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on January 11, 2006 and by facsimile on January 18, 2006. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-0624-7
CODE
Unit: 2076285
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on April 7, 2006 and by facsimile on April 13, 2006. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0625-7
CODE
Units: 71X322842 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc, Gainesville, FL, by facsimile on September 2, 2005.
Manufacturer:LifeSouth Community Blood Centers, Inc., Montgomery, AL. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Klebsiella Pneumoniae, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0628-7
CODE
Unit: 5496819 (Part 2)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on October 26, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0629-7
CODE
Units: 5472779 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone and facsimile on September 8, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

______________________________
PRODUCT
Human Corneas for Transplantation, Recall # B-0630-7
CODE
Tissues: 06-0207-100, 06-0207-200
RECALLING FIRM/MANUFACTURER
East Tennessee Lions Eye Bank, Knoxville, TN, by telephone on October 28, 2006. Firm initiated recall is complete.
REASON
Human tissues for transplantation, which tested negative for hepatitis prior to distribution, but were subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
NC

______________________________
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

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0652-7;
b) Red Blood Cells, Leukocytes Reduced, Irradiated,
Recall # B-0653-7
CODE
a) Units: 2603603, 2515530, 2707266;
b) Unit: 2423264
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile on February 1, 2006. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to hepatitis B core antigen (anti-HBc), but were collected from a donor who tested repeat reactive for anti-HBc on two previous occasions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TN

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0529-7;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0530-7
CODE
a) Units: 6546930, 6734352, 9112829, 9735551, 6734369, 6927409,
6546910, 6734581, 6745390, 6745392, 6745402, 9112861, 9200537,
9729838, 9733088, 9733113, 9733119, 9735077, 9735099, 9735558,
9735570, 6546920, 6739230, 6741358, 6741369, 6741373, 6741400,
6741413, 6742451, 6742947, 9112865, 9112887, 9112893, 9200529,
6732344, 9112853, 9112858, 9200526, 9200546, 6741352, 6741362;
b) Units: 9733074, 9733077, 9733065, 9733084, 6927393, 9733080,
6927378, 9729823, 9729832, 9733108, 9733116, 6734371, 9200515,
9729847
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on October 28, 2005. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE
55 units
DISTRIBUTION
CO and UT

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0531-7
CODE
Unit 22KL29993
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on June 6, 2006 and by letter dated June 8, 2006. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

______________________________
PRODUCT
a) Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0532-7;
b) Fresh Frozen Plasma Pheresis, Recall # B-0533-7
CODE
a) and b) Unit 5464246
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on January 13, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Aygestin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0534-7;
b) Platelets, Recall # B-0535-7;
c) Fresh Frozen Plasma, Recall # B-0536-7
CODE
a), b), and c) Unit: 5379562
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on January 13, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Aygestin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AR, and LA

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0568-7
CODE
Units: 040P11342 (split product)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL, by telephone on August 7, 2006. Firm initiated recall is complete.
REASON
Blood products, out of controlled storage for an undocumented length of time, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0572-7
CODE
Unit: 5398400
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by telephone and fax on June 6, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose hemoglobin was not recorded during screening, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

______________________________
PRODUCT
Red Blood Cells, Recall # B-0591-7
CODE
Units: 3938036, 3938009
RECALLING FIRM/MANUFACTURER
New York Blood Center Inc., New York, NY, by letter dated March 21, 2006. Firm initiated recall is complete.
REASON
Blood products, which lacked assurance of acceptable temperatures during shipping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Recall # B-0618-7;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated. Recall # B-0619-7
CODE
a) Unit: 2076816 (Part B);
b) Unit: 2076816 (Part A)
RECALLING FIRM/MANUFACTURER
Medic, Inc, Knoxville, TN, by telephone on April 20, 2006 and by letter dated April 25, 2006. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0623-7
CODE
Unit: 5458639
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center. Oklahoma City, OK, by facsimile on September 14, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0631-7
CODE
Unit: 2071441
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone and facsimile on January 3, 2006. Firm initiated recall is complete.
REASON
Blood product, for which there was no documentation of weld acceptability for the sterile docking of the filter, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
Recovered Plasma, Recall # B-0632-7
CODE
Unit: 2710197
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile on April 17, 2006. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information regarding a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0633-7
CODE
Unit: 2801011
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on November 23, 2005 and by facsimile on December 13, 2005. Firm initiated recall is complete.
REASON
Blood product, which contained a clot, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0639-7;
b) Red Blood Cells, Leukocytes Reduced, Irradiated,
Recall # B-0640-7;
c) Fresh Frozen Plasma, Recall # B-0641-7
CODE
a) Units: 2140453, 2140455, 2140460, 2140466, 2140469, 2140479, 2140483, 2140488, 2140494, 2140497, 2140502, 2140856, 2140858, 2140860, 2140865, 2140835, 2230832, 2230845, 2230848, 2230849, 2230851, 2230854, 2230857, 2230858, 2230861, 2230863, 2230870, 2230872, 2230874, 2230875, 2230881, 2230884, 2230885, 2230894, 2230896, 2231360, 2231362, 2231368, 2231370, 2231373, 2231376, 2231377, 2231381, 2231383, 2231525, 2334634, 2334636, 2334639, 2334640, 2334642, 2334643, 2334645, 2334647, 2334649, 2334651, 2334654, 2334656, 2334660, 2334662, 2334666, 2334862, 2334864, 2334865, 2334867, 2334869, 2334872, 2334873, 2334876, 2334877, 2334879, 2334884, 2334888, 2334889, 2334890, 2334891, 2334893, 2334894, 2334895, 2334901, 2334931, 2334933, 2334934, 2334936, 2334938, 2334939, 2334940, 2334941, 2334943, 2334944, 2334952, 2335061, 2335063, 2335065, 2335066, 2335070, 2335075, 2335076, 2335077, 2335078, 2335082, 2335085, 2335086, 2335090, 2335091, 2335096, 2335099, 2335101, 2335105, 2335113, 2335115, 2335118, 2335128, 2335130, 2335133, 2335135, 2335185, 2335255, 2429772, 2429774, 2429776, 2429778, 2429780, 2429783, 2429785, 2429787, 2429789, 2429792, 2429794, 2429795, 2429796, 2429798, 2429800, 2429801, 2429804, 2429805, 2429807, 2429813, 2429815, 2429816, 2429819, 2429930, 2429932, 2429933, 2429936, 2429938, 2429941, 2429942, 2429943, 2429945, 2429948, 2429949, 2429951, 2429954, 2429955, 2429956, 2429958, 2429960, 2429961, 2429962, 2429963, 2429965, 2429967, 2429968, 2429970, 2429971, 2429977, 2429979, 2429980, 2429981, 2429982, 2429985, 2429986, 2429988, 2429989, 2429991, 2429993, 2429994, 2430351, 2430353, 2430357, 2522969, 2522971, 2522972, 2522977, 2522979, 2522981, 2522984, 2522986, 2522988, 2522990, 2522993, 2522994;

b) Units: 2140476, 2230878, 2334929, 2334945, 2429771, 2429821, 2429937, 2429952;

c) Units: 2140494, 2230845, 2230848, 2230849, 2230851, 2230857, 2230870, 2230872, 2230875, 2230878, 2230881, 2230884, 2230885, 2230890, 2230894, 2334634, 2334640, 2334643, 2335101, 2335105, 2335185, 2335252, 2335255, 2335099
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone and facsimile on May 4, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose body temperature and pulse were not taken, were distributed.
VOLUME OF PRODUCT IN COMMERCE
224 units
DISTRIBUTION
KY and TN

______________________________
PRODUCT
a) Platelets, Leukocytes Reduced, Recall # B-0642-7;
b) Fresh Frozen Plasma, Recall # B-0643-7
CODE
a) and b) Unit: 033GR98228
RECALLING FIRM/MANUFACTURER
Firm: American National Red Cross, Connecticut Region, Farmington, CT, by telephone on October 6, 2006 and by facsimile on October 17, 2006. Firm initiated recall is complete.
REASON
Blood products, manufactured from a unit of Whole Blood with a discrepant collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CT

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

______________________________
PRODUCT
a) One Touch Basic/Profile and
b) One Touch Ultra- Blood Glucose Test Strips, Recall # Z-0266-2007
Code Information:
CODE
a) Lot #'s 2606340, 2619932, 272894A, 2615211;
b) Lot #'s 2691191, 2691261
RECALLING FIRM/MANUFACTURER
Core Care Technologies, Inc., Swell, NJ, by telephone and letter on November 21, 2006. Firm initiated recall is ongoing.
REASON
Counterfeit product.
VOLUME OF PRODUCT IN COMMERCE
24731 boxes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

______________________________
PRODUCT
Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70, Recall # Z-0299-2007
CODE
Serial Numbers: 111744, 112122, 112141, 112224, 112233, 114114, 116547, 116553, 117860, 117907, 110490, 100600, 110625, 110809, 113745, 113780, 112055 and 118943
RECALLING FIRM/MANUFACTURER
Advanced Bionics Corp., Sylmar, CA, by letters on September 21, 2006. Firm initiated recall is ongoing.
REASON
A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.
VOLUME OF PRODUCT IN COMMERCE
18
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S, Recall # Z-0318--2007
CODE
Lot numbers: 946DC131, 946DC239 and 946FC460
RECALLING FIRM/MANUFACTURER
Edwards LifeSciences Corp., of Puerto Rico, Anasco, PR, by voice mail on November 2, 2006. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
135 units (3 lots)
DISTRIBUTION
Nationwide and Italy

______________________________
PRODUCT
SPS Blue Line Tube Clamp Adapters, Product number BL120M, Recall # Z-0445-2007
CODE
Devices purchased between August 29 and September 20, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Southern Prosthetic Supply Co., Alpharetta, GA, by letters on October 6 and October 10, 2006.
Manufacturer: Medi Bayreuth, Bayreuth, Bavaria, Germany. Firm initiated recall is ongoing.
REASON
Device Fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail.
VOLUME OF PRODUCT IN COMMERCE
943 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) REMstar Heated Humidifier (Respiratory Gas Humidifier)
Model numbers: 1005792, U1005792, R1005792, SC1005792,
AC1005792, and 1007861, Recall # Z-0446-2007;
b) REMstar Heated Humidifer Main PCA Repair Kit,
Part number 1006265, Recall # Z-0447-2007
CODE
a) Serial numbers H045582 through H239662;
b) Lot number 020613, 020614, 020801, 020823, 020926,
021121, 021226, 030130, 030303, 030320, 303401,
303417, 030423, 030514, and 030611
RECALLING FIRM/MANUFACTURER
Respironics, Inc., Murrysville, PA, by letter dated October 25, 2006. Firm initiated recall is ongoing.
REASON
AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device.
VOLUME OF PRODUCT IN COMMERCE
172,000 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Left Medial/Right Lateral, Size 1, sterile;
Part number 1498-24-001, Recall # Z-0456-2007;
b) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Right Medial/Left Lateral, Size 1, sterile;
Part number 1498-23-001, Recall # Z-0457-2007;
c) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Left Medial/Right Lateral, Size 2, sterile;
Part number 1498-24-002, Recall # Z-0458-2007;
d) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Right Medial/Left Lateral, Size 2, sterile;
Part number 1498-23-002, Recall # Z-0459-2007;
e) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Left Medial/Right Lateral, Size 3, sterile;
Part number 1498-24-003, Recall # Z-0460-2007;
f) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Right Medial/Left Lateral, Size 3, sterile;
Part number 1498-23-003, Recall # Z-0461-2007;
g) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Left Medial/Right Lateral, Size 4, sterile;
Part number 1498-24-004, Recall # Z-0462-2007;
h) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Right Medial/Left Lateral, Size 4, sterile;
Part number 1498-23-004, Recall # Z-0463-2007;
i) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Left Medial/Right Lateral, Size 5, sterile;
Part number 1498-24-005, Recall # Z-0464-2007;
j) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Right Medial/left Lateral, Size 5, sterile;
Part number 1498-23-005, Recall # Z-0465-2007
CODE
All Lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by email on 11/15/06 and letter.
Manufacturer Firm: DePuy Ireland Ltd., Cork, Ireland. Firm initiated recall is ongoing.
REASON
Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
VOLUME OF PRODUCT IN COMMERCE
558
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Simplex P with Tobramycin. Antibiotic PMMA Bone Cement, Recall # Z-0467-2007
CODE
Lot Code MBN003, catalog no. 6197-9-010 (10 pk) Lot Code MBN003, catalog no. 6197-9-001 (1 pk) Lot Code MBN004; catalog no. 6197-9-010 (10 pk) Lot code MBN004; catalog no. 6197-9-001 (1 pk) Lot Code MBN003 and MBN004 - powder ''use by'' date 12/2007 Lot Code MBN003 and MBN004 - liquid ''use by'' date 9/2006 Product ''Use By'' Date: September 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., MahwahNJ., by letter on November 7, 2006.
Manufacturer: Stryker, Limerick, Ireland. Firm initiated recall is ongoing.
REASON
The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual subcomponents will support. The expiration date on the external package states December 2007 and the expiration date of the liquid monomer is September 2006.
VOLUME OF PRODUCT IN COMMERCE
813 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007, Recall # Z-0468-2007
CODE
Inner tube serial numbers beginning with 1472 through 1677 are suspect. This number is not traceable to the customer. The recall will be based on shipments made during the period that these numbers were in use.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ossur, Reykjavik, Iceland, by letter on November 9th, 2006.
Manufacturer: Ossur North America Inc., Aliso Viejo, CA. Firm initiated recall is ongoing.
REASON
Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising function and stability of the prosthetic foot.
VOLUME OF PRODUCT IN COMMERCE
138 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Howmedica Hip Fracture Stem System, Product Number: 6942-0-10,
No. 1 Femoral Component, Fenestrated Sterile Made in Ireland,
Recall # Z-0472-2007;
b) Howmedica Hip Fracture Stem System No. 2 Femoral
Component Fenestrated Sterile REF Catalogue #6942-0-020
Made in Ireland, Recall # Z-0473-2007;
c) Howmedica Hip Fracture Stem System No. 3 Femoral
Component Fenestrated Sterile REF Catalogue #6942-0-030
Made in Ireland, Recall # Z-0474-2007;
d) Howmedica Hip Fracture Stem System No. 3.5 Femoral
Component Uses No. 3 Fenestrated Plus Sterile REF
Catalogue #6942-0-035 Made in Ireland, Recall # Z-0475-2007;
e) Howmedica Hip Fracture Stem System No. 4 Femoral
Component Fenestrated Sterile REF Catalogue #6942-0-040
Made in Ireland, Recall # Z-0476-2007
CODE
a) Lot codes: 6499601, 6660201, 6660202, 6660203, 6660204,
6660205, 7237401, 7237402, 7237403, 7237404, 7237405,
7934101, 7934102, 7934103, 7934104, 7934105, 8345801,
8345802, 8345803, 8345804, 9714001, 9911901, 9911902,
10420701, 10420702, 10756001, 11319201, 11369101, 11369102,
11369103, 11605201, 11605202, 13093201, 13093301, 13093302,
13093401, 13093501, 13562501, 13562502, 13782001, 15550502,
16060001, 16060002, 16840301, 17289301, 17289302, 18448101,
18448102, 18448103, 18593901, 14413201R, P4FEA;
b) Lot Codes: 7237501, 7237502, 7237503, 7237505, 7600201,
7600202, 7662301, 7662302, 7662303, 7662304, 7692401,
7692402, 7692403, 7692406, 7805601, 7805602, 7805603,
7805604, 7934901, 7934902, 7944903, 7934904, 7999101,
7999102, 7999103, 7999104, 8152001, 8152002, 8152003,
8152004, 8152005, 8152006, 8152101, 8152102, 8152103,
8152104, 8241701, 8241702, 8241703, 8241704, 8241705,
8241706, 8345701, 8345702, 8345703, 8345704, 8478101,
8478102, 8478103, 8478104, 8569601, 8569602, 8632901,
8632902, 8633001, 8633101, 8633201, 8791103, 8791104,
8971301, 8993501, 8994801, 8995001, 8995601, 8995701,
9004401, 9004402, 9243601, 9243602, 9243603, 9400701,
9400702, 9400703, 9400704, 9400705, 9400706, 9475901,
9714101, 9714102, 9714104, 9911701, 9911702, 9911703,
9911705, 9911706, 9967201, 9967202, 9967203, 10353602,
10362901, 10420901, 10421001, 10585002, 10585003, 10585004,
10585005, 10585006, 10673301, 10673302, 10673303, 11064601,
11064602, 11064603, 11089903, 11089904, 11369301, 11369302,
11369303, 11436901, 11436902, 11605301, 11604302, 11791901,
11791902, 11791903, 11920901, 11920902, 11920903, 12084501,
12084502, 12084503, 12084505, 12406801, 12406802, 12406803,
12406901, 12947501, 12947502, 12947503, 12947504, 13184201,
13184202, 13184203, 13184204, 13184301, 13412201, 13412202,
13412203, 13782102, 13782104, 13793501, 13973502, 13984701,
13984702, 13984703, 14108402, 14196701, 14196702, 14274601,
14368101, 14368102, 14368103, 15485101, 15485102, 15485103,
15485104, 15485105, 15668701, 15668702, 15953601, 15953602,
15953603, 15953604, 15953605, 15953606, 16059801, 16059802,
16059803, 16165601, 16203701, 16203702, 16499401, 16499402,
16499403, 16499404, 16937901, 16937902, 16937904, 17220101,
17220102, 17220103, 17220104, 17307801, 17307802, 17307804,
17658001, 17658002, 17658003, 17745201, 17745202, 17745203,
17969401, 17969402, 18320601, 18320602, 18448602, 18594101,
18594102, 18594601, 19246901, 19247001, 19247101, 19329001,
19329002, 19532501, 19532504, 19577101, 19577102,19826201,
19826203, 15953604R, 19329001R, 7805601R;
c) Lot codes: 7238602, 7238603, 7238604, 7353002, 7353003,
7600501, 7600502, 7692501, 7692503, 7692504, 7692505,
7292506, 7935101, 7935102, 7935103, 7999701, 7999702,
7999703, 7999801, 7999803, 8152201, 8152203, 8152204,
8152205, 8152206, 8152207, 8152208, 8241801, 8241802,
8242101, 8252102, 8242103, 8345503, 8345504, 8531601,
8531901, 8532001, 8532301, 8532401, 8532501, 8532601,
8643301, 8643302, 8643303, 8643304, 8643305, 8850801,
8850802, 8850901, 8850902, 8850903, 9011101, 9044301,
9044302, 9044303, 9044304, 9090101, 9124401, 9400801,
9400802, 9400803, 9503202, 9574801, 9911802, 9911803,
9948101, 9948102, 10164601, 10164602, 10212501, 10317501,
10353702, 10353703, 10917801, 10917802, 10917803,
10917804, 10917806, 11064501, 11064503, 11092701,
11092702, 11092703, 11092704, 11092705, 11369401,
11369402, 11605501, 11607801, 12407001, 12407003,
12407005, 12407006, 12870602, 12870603, 12870604,
12947201, 12947202, 12947203, 13294601, 13294602,
13294603, 13294604, 13294605, 13294606, 13412101,
13412102, 13412103, 13412104, 13782202, 13782203,
13782204, 13782205, 14377903, 14412801, 14412804,
14412805, 14682701, 14682702, 14738901, 15236201,
15550301, 15550302, 15550303, 16059701, 16059703,
16059704, 16059705, 16059706, 16165503, 16499502,
16750801, 16937801, 16937802, 16937803, 16937804,
16937805, 16937806, 17540401, , 17540402, 17657902,
17657903, 17745101, 17842801, 17842802, 17842803,
18062101, 18062202, 18131401, 18131402, 18131403,
18448701, 18448702, 18594201, 18594202, 18594203,
18946901, 18946902, 19428801, 19673002, 19673003,
19673004, 19726201, 20304601, 20304602, 20304604,
20304607, 7023401R;
d) Lot codes: 7566701, 7819401, 7819402, 7819403, 7819405, 7869001,
7869002, 7869003, 7869004, 7869005, 7935701, 7935702, 7935704,
7999901, 7999902, 8152301, 8152302, 8152303, 8242501, 8850401,
8850402, 8850403, 8850404, 9503301, 9844801, 9844802, 9948201,
9948203, 10546201, 10546202, 10673501, 11090201, 11319301,
11319302, 11319303, 11369601, 11605702, 16033902, 16033903,
16165902, 16166001, 16840401, 16840402, 17289401, 17289402,
18448001, 18448002, 19131601, 10131602, 19490903, 19490904,
19834301;
e) Lot codes: 7567401, 7799201, 7868901, 7868902, 7868903,
7936001, 7936002, 8243001, 8243002, 9401001, 9948301,
9948302, 9948304, 14342101, 17596001, 17596002, 17810901,
17969201, 18062501, 18062502, 18062503, 8243003R, MPRTA.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on November 29, 2006.
Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, Ireland. Firm initiated recall is ongoing.
REASON
Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.
VOLUME OF PRODUCT IN COMMERCE
1,657 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; model number HMB002-US, Recall # Z-0478-2007
CODE
All serial numbers manufactured prior to June 2004. The production date can be determined by the serial number on the mast of the lift. Serial numbers start with MPLA or MPLAT, followed by the last two digits of the year and two digits for the month of production, i.e. MPLA0103 = March 2001.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, by letter dated August 31, 2006.
Manufacturer: Arjo Med. AB, Gloucester, UK. Firm initiated recall is ongoing.
REASON
The hanger bar assembly may detach from the lift during use due to fatigue failure of the bolt.
VOLUME OF PRODUCT IN COMMERCE
76 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600 Ceiling Patient Lift. The fixed gate, part #700.11550, was sold in two kits: a) Part #700.11500 Kwiktrak Gate Kit composed of the fixed gate and a 3-contact interface kit part #700.15515, and b) Part #700-11505 Double Gate Kit composed of two fixed gates and 3-contact interface kits, Recall # Z-0479-2007
CODE
All fixed gate components.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, by letters on October 30, 2006.
Manufacturer: B. H. M. Medical, Inc., Magog Quebec, Canada. Firm initiated recall is ongoing.
REASON
The Kwiktrak Gate stopper may fail and allow the ceiling lift to pass through to the end of the track and fail to the floor.
VOLUME OF PRODUCT IN COMMERCE
3 gate systems
DISTRIBUTION
MI, OH, and IL

______________________________
PRODUCT
a) Viasys V.I.P. Bird Gold pediatric ventilator, Catalog
Number 15653, Recall # Z-0480-2007;
b) Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog
Number 15654, Recall # Z-0481-2007
CODE
a) Serial numbers: AAM01001 to AMM01590 + KJI001178
and AAMO1648 to AEM01298;
b) Serial numbers: AAM01128 to ABMO1015 and AAM1119
to ACMO1142
RECALLING FIRM/MANUFACTURER
Viasys Respiratory Care, Inc., Palm Springs, CA., by letters on November 2, 2006 and November 4, 2006. Firm initiated recall is ongoing.
REASON
The correction is due to a repeat “failure to cycle” event.
VOLUME OF PRODUCT IN COMMERCE
2,017 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect the lift to the BHM Track or KwikTrak Trolley. The reacher comes in two models: part #700.08310 - 24' handle length, and part #700.08320 - 36' handle length, Recall # Z-0482-2007
CODE
Part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length, all reachers shipped between November 2003 through November 6, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, by letters on November 13, 2006.
Manufacturer: B. H. M. Medical, Inc., Magog Quebec, Canada. Firm initiated recall is ongoing.
REASON
The carabineer may not be correctly attached to the reacher and the portable patient lift may drop.
VOLUME OF PRODUCT IN COMMERCE
886 reachers
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Baxter Colleague Single Channel Volumetric Infusion Pumps;
Made in Singapore; product codes 2M8151, 2M8151R,
2M8161, 2M8161R, Recall # Z-0483-2007;
b) Baxter Colleague Triple Channel Volumetric Infusion Pumps;
Made in Singapore; product codes 2M8153, 2M8153R,
2M8163, 2M8163R, Recall # 0484-2007
CODE
All serial numbers used in or near linear accelerator suites
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter on December 6, 2006.
Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
REASON
Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user.
VOLUME OF PRODUCT IN COMMERCE
344,074 pumps
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) GammaMed 12i radionuclide applicator systems, Recall # Z-0486-2007;
b) GammaMed 12it radionuclide applicator system, Recall # Z-0487-2007
CODE
a) H630701 H630703 H630704 H630705 H630706 H630708
H630710 H630711 H630712 H630713 H630714 H630715
H630716 H630718 H630719 H630720 H630721 H630722
H630723 H630724 H630725 H630727 H630728 H630729
H630730 H630732 H630733 H630735 H630736 H630737
H630739;
b) H630202
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems, Charlottesville, VA, by e-mail and letter on September 11, 2006.
Manufacturer: Varian Medical Systems Haan, Haan, Federal Republic of Germany.
REASON
Medical device for patient treatment does not meet electrical safety standards.
VOLUME OF PRODUCT IN COMMERCE
44 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 tests), and 6C25-30 (4 x 500 tests), Recall # Z-0488-2007
CODE
Lot numbers 33198M200 and 41861M100, 33198M201, and 33871M100. All lots expire 6/16/2007.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories MPG, Abbott Park, IL, by letter dated November 22, 2006. Firm initiated recall is ongoing.
REASON
The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that are elevated. Correlation studies have demonstrated an upward shift in slope for patient results of approximately 13% on average when compared to other currently available reagent lots and an average bias from patient specimens of 13% to 17% has been observed.
VOLUME OF PRODUCT IN COMMERCE
2, 960 kits
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

______________________________
PRODUCT
International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint & Protimepro, Protimeintrf & Protimeprorf, Protimeintl & Protimeprol, Recall # Z-0470-2007
CODE
Serial Number's V50000 V50002 V50004 V50005 V50006 V50007 V50008 V50009 V50010 V50012 V50013 V50014 V50018 V50021 V50022 V50024 V50026 V50028 V50030 V50032 V50033 V50034 V50037 V50041 V50043 V50046 V50048 V50049 V50054 V50055 V50056 V50058 V50063 V50064 V50066 V50067 V50069 V50070 V50072 V50073 V50074 V50075 V50076 V50077 V50078 V50079 V50080 V50083 V50086 V50087 V50088 V50091 V50093 V50096 V50098 V50099 V50101 V50102 V50103 V50104 V50105 V50106 V50107 V50109 V50111 V50112 V50114 V50115 V50116 V50117 V50119 V50121 V50122 V50123 V50124 V50125 V50130 V50131 V50132 V50134 V50135 V50136 V50137 V50140 V50141 V50143 V50144 V50145 V50146 V50148 V50150 V50151 V50153 V50156 V50157 V50158 V50159 V50160 V50164 V50165 V50166 V50168 V50170 V50174 V50175 V50176 V50177 V50178 V50180 V50181 V50183 V50185 V50186 V50187 V50188 V50190 V50191 V50194 V50196 V50198 V50199 V50200 V50202 V50203 V50205 V50206 V50207 V50208 V50210 V50211 V50212 V50213 V50214 V50215 V50218 V50219 V50222 V50227 V50228 V50229 V50230 V50231 V50232 V50233 V50235 V50236 V50239 V50241 V50244 V50245 V50246 V50247 V50248 V50249 V50251 V50252 V50253 V50257 V50260 V50262 V50264 V50266 V50267 V50268 V50271 V50273 V50274 V50276 V50277 V50278 V50279 V50280 V50283 V50291 V50294 V50295 V50296 V50297 V50298 V50299 V50300 V50301 V50302 V50304 V50305 V50307 V50310 V50312 V50315 V50319 V50320 V50322 V50323 V50325 V50326 V50327 V50328 V50329 V50335 V50336 V50337 V50338 V50339 V50341 V50343 V50347 V50348 V50352 V50353 V50354 V50357 V50359 V50361 V50366 V50367 V50368 V50370 V50371 V50372 V50375 V50377 V50378 V50380 V50382 V50385 V50387 V50388 V50389 V50392 V50393 V50394 V50395 V50398 V50400 V50402 V50403 V50404 V50406 V50408 V50409 V50410 V50411 V50413 V50414 V50415 V50416 V50417 V50422 V50423 V50424 V50425 V50427 V50428 V50429 V50430 V50432 V50435 V50436 V50437 V50438 V50439 V50440 V50442 V50444 V50446 V50447 V50453 V50454 V50459 V50461 V50463 V50464 V50467 V50470 V50471 V50473 V50475 V50477 V50478 V50480 V50483 V50485 V50486 V50487 V50491 V50492 V50493 V50498 V50501 V50502 V50503 V50504 V50505 V50506 V50507 V50508 V50509 V50510 V50511 V50513 V50514 V50515 V50516 V50517 V50518 V50519 V50520 V50521 V50522 V50523 V50524 V50526 V50527 V50529 V50531 V50533 V50534 V50536 V50539 V50540 V50541 V50542 V50543 V50544 V50545 V50546 V50547 V50549 V50551 V50552 V50555 V50556 V50557 V50558 V50559 V50560 V50562 V50565 V50566 V50568 V50569 V50570 V50571 V50572 V50574 V50575 V50576 V50577 V50578 V50579 V50580 V50582 V50583 V50584 V50586 V50587 V50588 V50589 V50590 V50591 V50592 V50593 V50594 V50595 V50596 V50597 V50598 V50599 V50601 V50602 V50603 V50604 V50605 V50606 V50607 V50608 V50609 V50612 V50613 V50614 V50615 V50616 V50619 V50620 V50621 V50623 V50625 V50626 V50628 V50630 V50634 V50635 V50636 V50637 V50640 V50641 V50642 V50645 V50647 V50650 V50652 V50653 V50655 V50656 V50657 V50658 V50659 V50661 V50662 V50663 V50664 V50665 V50666 V50667 V50669 V50670 V50671 V50672 V50673 V50676 V50679 V50680 V50682 V50683 V50685 V50686 V50687 V50688 V50689 V50690 V50691 V50692 V50693 V50694 V50697 V50700 V50701 V50703 V50704 V50705 V50707 V50708 V50709 V50710 V50712 V50713 V50714 V50715 V50716 V50717 V50719 V50720 V50722 V50723 V50724 V50725 V50727 V50728 V50729 V50732 V50733 V50734 V50735 V50736 V50737 V50738 V50739 V50743 V50744 V50746 V50748 V50749 V50750 V50752 V50754 V50756 V50757 V50758 V50759 V50761 V50762 V50763 V50764 V50765 V50766 V50768 V50770 V50771 V50772 V50773 V50774 V50775 V50776 V50777 V50778 V50780 V50783 V50784 V50785 V50786 V50787 V50788 V50792 V50793 V50794 V50795 V50796 V50797 V50798 V50800 V50801 V50802 V50803 V50804 V50805 V50807 V50808 V50809 V50810 V50811 V50812 V50814 V50815 V50816 V50817 V50818 V50820 V50821 V50822 V50823 V50824 V50825 V50826 V50827 V50828 V50829 V50830 V50831 V50833 V50834 V50836 V50837 V50838 V50839 V50840 V50841 V50842 V50843 V50844 V50845 V50847 V50849 V50850 V50851 V50852 V50854 V50856 V50857 V50859 V50860 V50861 V50862 V50863 V50864 V50865 V50867 V50868 V50869 V50870 V50871 V50872 V50873 V50874 V50875 V50876 V50878 V50879 V50880 V50881 V50882 V50883 V50884 V50885 V50887 V50888 V50889 V50890 V50891 V50892 V50893 V50895 V50896 V50897 V50898 V50899 V50900 V50901 V50903 V50904 V50906 V50907 V50908 V50910 V50911 V50912 V50913 V50914 V50917 V50918 V50919 V50921 V50922 V50923 V50925 V50926 V50927 V50929 V50930 V50932 V50933 V50934 V50935 V50936 V50938 V50939 V50940 V50941 V50942 V50943 V50944 V50945 V50946 V50947 V50949 V50950 V50951 V50954 V50956 V50957 V50958 V50959 V50960 V50961 V50962 V50963 V50964 V50967 V50968 V50970 V50972 V50974 V50975 V50976 V50978 V50981 V50982 V50983 V50984 V50985 V50986 V50991 V50992 V50994 V50995 V50996 V50997 V50998 V50999 V51000 V51001 V51003 V51004 V51005 V51006 V51008 V51009 V51010 V51011 V51012 V51013 V51014 V51015 V51016 V51017 V51018 V51019 V51020 V51021 V51022 V51023 V51024 V51027 V51029 V51030 V51031 V51032 V51034 V51036 V51037 V51038 V51039 V51040 V51043 V51044 V51045 V51046 V51047 V51048 V51049 V51050 V51051 V51052 V51053 V51054 V51055 V51056 V51058 V51059 V51060 V51062 V51063 V51064 V51065 V51067 V51068 V51069 V51070 V51071 V51073 V51074 V51075 V51076 V51077 V51079 V51080 V51081 V51082 V51083 V51084 V51085 V51086 V51088 V51089 V51090 V51091 V51092 V51093 V51094 V51095 V51096 V51097 V51100 V51101 V51102 V51103 V51105 V51106 V51107 V51108 V51110 V51111 V51112 V51113 V51114 V51115 V51116 V51118 V51119 V51120 V51121 V51122 V51123 V51125 V51126 V51127 V51128 V51129 V51130 V51131 V51132 V51134 V51135 V51137 V51138 V51139 V51140 V51141 V51142 V51143 V51145 V51146 V51148 V51149 V51150 V51152 V51154 V51155 V51157 V51158 V51159 V51160 V51161 V51162 V51163 V51164 V51166 V51167 V51168 V51170 V51171 V51173 V51176 V51177 V51180 V51182 V51184 V51195 V51199 V51202 V51204 V51209 V51212 V51214 V51215 V51217 V51219 V51222 V51223 V51224 V51225 V51226 V51227 V51228 V51230 V51231 V51232 V51233 V51234 V51236 V51237 V51238 V51239 V51240 V51242 V51244 V51246 V51247 V51248 V51249 V51250 V51251 V51256 V51260 V51261 V51270 V51271 V51274 V51280 V51281 V51282 V51285 V51288 V51289 V51290 V51296 V51297 V51300 V51301 V51303 V51304 V51305 V51306 V51307 V51308 V51309 V51310 V51311 V51312 V51313 V51314 V51315 V51316 V51317 V51320 V51322 V51323 V51324 V51325 V51326 V51334 V51337 V51338 V51339 V51340 V51342 V51343 V51344 V51346 V51349 V51350 V51354 V51356 V51357 V51358 V51359 V51360 V51361 V51362 V51363 V51364 V51365 V51367 V51368 V51369 V51370 V51372 V51373 V51375 V51376 V51377 V51378 V51380 V51381 V51382 V51383 V51384 V51385 V51387 V51392 V51396 V51398 V51399 V51400 V51404 V51405 V51407 V51411 V51412 V51413 V51415 V51416 V51422 V51424 V51426 V51428 V51429 V51430 V51431 V51432 V51433 V51435 V51436 V51440 V51441 V51443 V51444 V51445 V51446 V51447 V51448 V51450 V51451 V51452 V51453 V51454 V51455 V51458 V51459 V51460 V51461 V51462 V51463 V51464 V51466 V51467 V51468 V51469 V51471 V51473 V51474 V51475 V51476 V51477 V51478 V51480 V51481 V51484 V51485 V51487 V51490 V51491 V51493 V51494 V51495 V51497 V51751 V51752 V51753 V51754 V51755 V51756 V51759 V51760 V51762 V51764 V51766 V51767 V51768 V51771 V51772 V51774 V51775 V51777 V51778 V51779 V51782 V51783 V51785 V51786 V51788 V51794 V51795 V51796 V51797 V51800 V51801 V51802 V51803 V51804 V51805 V51806 V51807 V51808 V51809 V51810 V51811 V51812 V51815 V51816 V51817 V51818 V51819 V51820 V51822 V51823 V51824 V51826 V51827 V51829 V51830 V51831 V51832 V51833 V51835 V51839 V51842 V51845 V51847 V51849 V51850 V51851 V51852 V51854 V51856 V51857 V51858 V51859 V51861 V51862 V51863 V51864 V51865 V51867 V51868 V51870 V51872 V51874 V51875 V51876 V51877 V51879 V51880 V51881 V51883 V51884 V51886 V51891 V51893 V51894 V51895 V51896 V51897 V51901 V51902 V51903 V51904 V51905 V51906 V51907 V51909 V51910 V51911 V51912 V51914 V51915 V51916 V51917 V51918 V51919 V51921 V51923 V51925 V51926 V51927 V51928 V51929 V51931 V51932 V51933 V51934 V51935 V51936 V51938 V51939 V51940 V51942 V51943 V51944 V51948 V51952 V51953 V51958 V51961 V51963 V51973 V51974 V51978 V51985 V51986 V51987 V51988 V51991 V51994 V51995 V51997 V51999 V52000 V52002 V52003 V52004 V52005 V52006 V52007 V52008 V52009 V52011 V52012 V52015 V52016 V52018 V52019 V52021 V52022 V52025 V52026 V52027 V52030 V52032 V52033 V52035 V52037 V52038 V52039 V52041 V52042 V52045 V52046 V52047 V52048 V52051 V52053 V52054 V52056 V52057 V52058 V52059 V52060 V52061 V52062 V52064 V52066 V52067 V52068 V52069 V52072 V52073 V52074 V52075 V52076 V52080 V52081 V52082 V52083 V52084 V52085 V52089 V52090 V52092 V52095 V52098 V52100 V52101 V52103 V52104 V52105 V52106 V52110 V52111 V52112 V52113 V52114 V52115 V52116 V52117 V52118 V52119 V52121 V52122 V52123 V52124 V52125 V52131 V52133 V52135 V52137 V52138 V52139 V52143 V52144 V52145 V52147 V52148 V52149 V52151 V52153 V52154 V52155 V52157 V52159 V52161 V52162 V52163 V52165 V52166 V52169 V52171 V52172 V52174 V52175 V52178 V52182 V52184 V52186 V52187 V52190 V52191 V52195 V52196 V52197 V52201 V52202 V52203 V52206 V52212 V52213 V52214 V52218 V52220 V52222 V52224 V52228 V52229 V52230 V52231 V52232 V52233 V52234 V52236 V52238 V52241 V52242 V52243 V52244 V52247 V52249 V52250 V52251 V52252 V52253 V52256 V52259 V52260 V52261 V52262 V52266 V52267 V52268 V52270 V52271 V52273 V52275 V52276 V52279 V52280 V52281 V52283 V52284 V52285 V52288 V52291 V52292 V52293 V52295 V52296 V52297 V52299 V52301 V52302 V52303 V52304 V52305 V52306 V52307 V52308 V52309 V52312 V52313 V52314 V52316 V52318 V52319 V52320 V52321 V52322 V52323 V52324 V52325 V52327 V52328 V52333 V52334 V52335 V52338 V52340 V52341 V52342 V52343 V52344 V52347 V52348 V52349 V52350 V52353 V52356 V52357 V52358 V52359 V52360 V52361 V52362 V52364 V52365 V52366 V52367 V52368 V52369 V52370 V52371 V52373 V52375 V52376 V52377 V52378 V52379 V52381 V52382 V52383 V52384 V52385 V52388 V52389 V52390 V52391 V52393 V52394 V52395 V52397 V52398 V52399 V52401 V52403 V52404 V52406 V52407 V52408 V52409 V52411 V52412 V52413 V52415 V52417 V52418 V52419 V52420 V52421 V52422 V52423 V52424 V52426 V52427 V52428 V52429 V52430 V52431 V52432 V52433 V52434 V52435 V52437 V52438 V52439 V52440 V52441 V52442 V52443 V52444 V52445 V52446 V52447 V52448 V52450 V52452 V52453 V52454 V52455 V52456 V52457 V52458 V52460 V52461 V52462 V52463 V52464 V52466 V52467 V52468 V52469 V52470 V52472 V52473 V52474 V52475 V52476 V52477 V52478 V52479 V52480 V52481 V52482 V52483 V52484 V52486 V52487 V52488 V52490 V52491 V52492 V52502 V52506 V52533 V52534 V52547 V52548 V52550 V52551 V52554 V52556 V52557 V52558 V52559 V52562 V52569 V52570 V52575 V52576 V52577 V52578 V52579 V52587 V52588 V52590 V52591 V52592 V52594 V52597 V52603 V52604 V52607 V52619 V52620 V52621 V52632 V52635 V52637 V52640 V52646 V52791 V52795 V52797 V52798 V52799 V52800 V52802 V52806 V52807 V52808 V52814 V52818 V52823 V52824 V52825 V52826 V52827 V52832 V52833 V52836 V52837 V52838
RECALLING FIRM/MANUFACTURER
International Technidyne Corp., Edison, NJ, by letter, on December 6, 2006. Firm initiated recall is ongoing.
REASON
Incorrect Test Results-ProTime ITC's Microcoagulation System: Professional Instrument may report incorrect test results when more than 50 tests are in the memory and the technician uses the AUTO Send or PRINT RESULTS feature.
VOLUME OF PRODUCT IN COMMERCE
1,538 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR JANUARY 17, 2007

###

rule