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U.S. Department of Health and Human Services

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Enforcement Report for February 7, 2007

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.

February 7, 2007
07-06

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS I

______________________________
PRODUCT
a) Good Karma Organic Rice Cream Mudd Pie Non-Dairy Frozen Dessert,
1 pint, packaged in 8 pack, blue packaging with dark brown lid band and a banner
that reads Mudd Pie. UPC code on product is 2946270102, Recall # F-111-7;
b) Good Karma Organic Rice Cream Mint Chocolate Chip Non-Dairy Frozen Dessert,
1 pint, packaged in an 8 and 24 count. Item in blue packaging with green lid band
and a banner that reads Mint Chocolate Chip. UPC code on product is 2946270106,
Recall # F-112-7;
c) Good Karma Organic Rice Cream Chocolate Peanut Butter Fudge Non-Dairy
Frozen Dessert, 1 pint, packed in an 8 and 24 count. Item comes in a blue package
with a light brown lid band and a banner that reads Chocolate Peanut Butter Fudge.
UPC code on product is 2946270105, Recall # F-113-7
CODE
a) Use by dates: 4/19/2007, 5/2/2007, 6/8/2007;
b) Best If Used By dates - 8 pack: 4/18/2007, 5/2/2007, 6/6/2007;
24-pk: 6/21/2007, 6/27/2007, 7/19/2007, 7/27/2007;
c) Best If Used By dates - 8 pack: 4/18/2007, 4/25/2007, 5/31/2007;
24-pk: 6/22/2007, 6/28/2007, 7/20/2007, 7/26/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Good Kama Foods Technologies, Inc., Glendale, CA, by press release on August 22, 2006 and by letters dated August 25, 2006.
Manufacturer: Schoep, Madison, WI. Firm initiated recall is ongoing.
REASON
The product may contain undeclared milk protein.
VOLUME OF PRODUCT IN COMMERCE
8 pack: 4390cs Mudd Pie, 3403cs Mint Chocolate chip, 3575cs Choc Peanut Butter Fudge. 24 pack: 3442cs Mint Choc chip, 3563cs Choc Peanut Butter Fudge
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Price's Orange Drink, 1 gallon jugs and Price's Orange Flavored Drink, 16 oz bottles, Recall # F-114-7
CODE
Best By "1-25-07"
RECALLING FIRM/MANUFACTURER
Prices Creameries, El Paso, TX, by press release, telephone and visit on November 3-4, 2006. Firm initiated recall is complete.
REASON
Product may contain undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
652/1 gallon containers and 464/16 fl. oz. containers
DISTRIBUTION
TX and NM

______________________________
PRODUCT
Lucia brand cantaloupes, 12 pieces of fruit per carton, Recall # F-116-7
CODE
RACA 02 ARRIVAL 000863
RECALLING FIRM/MANUFACTURER
Recalling Firm: Farmer, Rio Rico, AZ, by email on November 16, 2006.
Manufacturer: Agroproductos San Rafael S. A. de C. V., Ciudad Obregon, Mexico. Firm initiated recall is complete.
REASON
Sample analysis by the FDA found the product contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
672 cartons
DISTRIBUTION
NY, MI, CA

______________________________
PRODUCT
Reese's Shell Topping, Chocolate and Peanut Butter Flavor. The product is sold in 7.25 oz bottles with UPC number 346010. The product is shipped in cases containing 12 bottles, Recall # F-117-7
CODE
Lot number: 30MXB
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hershey Foods Corp., Hershey, PA., by telephone on November 11, 2006 and by press release on November 14, 2006.
Manufacturer: Hershey Canada, Inc., Smith Falls, Ontario, Canada. Firm initiated recall is complete.
REASON
The product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
9 cases and 7 bottles
DISTRIBUTION
MI

______________________________
PRODUCT
HDC brand, fresh perishable cantaloupes grown in Mexico, packed in cardboard cartons whose size was approximately 1 bushel in measurement. Packed 9 to 23 per case depending on the size of the melon., Recall # F-118-7
CODE
Product was not coded.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vandervoet & Associates, Inc, Rio Rico, AZ., by telephone on November 17, 20 and 21, 2006, and by letters on December 7 and 8, 2006.
Manufacturer: Giadela S.P.R. De R.L., Hermosillo, Sonora, Mexico. Firm initiated recall is ongoing.
REASON
Sample analysis by the FDA found the product contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
8,407 cartons
DISTRIBUTION
Nationwide and Canada

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

______________________________
PRODUCT
Neophase Natural Sex Enhancer formula for MEN Herbal Supplement, Proprietary Blend 700mg of Ginsenoside, Rhodiola crenulata root, Lysium chinesis fruit, Curculigo rhizome root, Licorice root, Snow lotus flower, Cuscuta chinesis and Cordyceps sinensis, 4 Soft capsules per bottle, Recall # D-435-2007
CODE
All Codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: North American Distributor Group, LLC, San Francisco, CA, by e-mails and letters on July 17, 2006.
Manufacturer: Vigor Nutriceutical, Inc., Sun Prairie, WI. Firm initiated recall is complete.
REASON
Unapproved New Drug; product found to contain homosildenafil, an analogue of sildenafil.
VOLUME OF PRODUCT IN COMMERCE
396 bottles
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
a) Skin Effects Daily Anti-Aging Cream with SPF 15, (Octinoxate 7.5%, Oxybenzone 5%),
Net Wt. 2 oz (56g) jars, UPC 0-50428-07901-0, Recall # D-425-2007;
b) Skin Effects by Dr. Jeffrey Dover Advanced Brightening Complex, (Hydroquinone) 2%,
Net wt. 1oz (28.4g), UPC 0-50428-07899-0; Recall # D-426-2007;
c) Skin Effects by Dr. Jeffrey Dover Complete Lip Care System (Avobenzone 2% and
Octinoxate 7.5%), System includes; Lip Smoothing Scrub Net wt. .49 oz. (14g),
Peptide Treatment Serum Net wt. .08 oz. (2.4g) and Lip Balm SPF 15 Net wt. .08 oz. (2.3g),
UPC 0-500428-08677-3, Recall # D-427-2007;
d) Skin Effects by Dr. Jeffrey Dover Lightweight Moisturizing Souffle with SPF 30+,
(Avobenzone 3%, Octinoxate 7.5%, and Octisalate 5%), Net wt. 1 oz. (29g) jars,
UPC 0-50428-09340-5, Recall # D-428-2007;
e) Skin Effects by Dr. Jeffrey Dover Redness Control Daily UV Moisturizer SPF 30+,
(Octinoxate 7%, Oxybenzone 6% and Octisalate 5%), Net wt. 1 oz. (29g) jars,
UPC 0-50428-09341-2; Recall # D-429-2007;
f) Skin Effects by Dr. Jeffrey Dover Lightweight Moisturizing Souffle SPF 30+ for
Sensitive Skin, (Avobenzone 3%, Octinoxate 7.5%, and Octisalate 5%), Net wt. 1 oz.
(29g) jars, UPC 0-50428-09339-9, Recall # D-430-2007
CODE
a) Lot Number/EXP Date: FT5 EXP. 0507 F25 EXP 0507 F35 EXP 0607
GG5 EXP0507 GZ5 EXP0607 GY5 EXP0607 HL5 EXP 0607 A05 EXP0607
KD5 EXP0607 BG6 EXP0208 BI6 EXP0208 ED6 EXP0408 EZ6 EXP0408
HY6 EXP0408 JY6 EXP0708;
b) Lot Numbers/EXP Date: FT5 EXP 0607 FX5 EXP 0607 GS5 EXP 0607
GV5 EXP0607 HE5 EXP 0607 LA5 EXP 1107 LE5 EXP 1107 LB5 EXP 1107
LC5 EXP 1107 LF5 EXP1107;
c) Lot Numbers/Exp Date: LOT BG6 EXP 0108 LOT BJ6 EXP 0108 LOT BM6 EXP 0108;
d) Lot Numbers: FG6 EXP 0408 GL6 EXP 0408 J56 EXP1008;
e) Lot Numbers: 6E1 EXP 0508 42734-0 EXP 1008;
f) Lot Numbers; FI6 EXP 0408 GM6 EXP 0408 J66 EXP 1008
RECALLING FIRM/MANUFACTURER
Diversified Distribution, Woonsocket, RI, by telephone on November 7, 2006. Firm initiated recall is ongoing.
REASON
Labeling; Outer carton fails to include lot number and expiration.
VOLUME OF PRODUCT IN COMMERCE
129,298 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Assured Cough Drops Cherry (Menthol) 7.0 mg, Cough Suppressant and Oral Anesthetic, 50 individually wrapped drops per bag, 12 bags per case; UPC 6 39277 01822 9, Recall # D-432-2007
CODE
Lot numbers A6256, B6256, A6257, B6257
RECALLING FIRM/MANUFACTURER
Primrose Candy Co., Chicago, IL, by e-mail on December 16, 2006 and December 19, 2006. Firm initiated recall is ongoing.
REASON
Mislabeled; product interior wrapper incorrectly labeled as "Sugar Free"
VOLUME OF PRODUCT IN COMMERCE
338 cases
DISTRIBUTION
GA and WA

______________________________
PRODUCT
Ciprofloxacin Injection, USP 1200mg (10mg/mL), 120mL vial, Pharmacy Bulk Package, Not For Direct Infusion, Rx only, Recall # D-433-2007
CODE
Lot 1161864, expiration date 10/08.
RECALLING FIRM/MANUFACTURER
Ben Venue Laboratories, Inc., Bedford, OH, by letter dated January 18, 2007. Firm initiated recall is ongoing.
REASON
Mislabeled; carton and vial label incorrectly states 12 g per 120 mL sterile 1% solution, but should correctly state 1.2 g per 120 mL sterile 1% solution.
VOLUME OF PRODUCT IN COMMERCE
903 vials
DISTRIBUTION
Nationwide
__________________________
PRODUCT
a) Bacitraycin Plus with Moisturizing Aloe First Aid Ointment,
(Bacitracin, 500 units), 1.0 oz. (28 g) tube, Recall # D-436-2007;
b) Bacitraycin Plus with Moisturizing Aloe Maximum Strength First Aid Ointment,
(Bacitracin, 500 units, Pramoxine HCl 10mg), 1.0 oz. (28 g) tube, Recall # D-437-2007
CODE
a) Lot Numbers: 60126E1208, 60127E1208, 60130 E1208;
b) Lot numbers 60314E0108, 60315E0108
RECALLING FIRM/MANUFACTURER
Sheffied Laboratories, Div., of Faria Limited LLC, New London, CT., by telephone, letter, facsimile, or e-mail on December 28, 2006. Firm initiated recall is ongoing.
REASON
Product stability may not be assured to expiration.
VOLUME OF PRODUCT IN COMMERCE
102,288 tubes
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0042-07
CODE
Unit: 2342929
RECALLING FIRM/MANUFACTURER
Medic Inc. Knoxville, TN, by telephone on March 20, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0043-07
CODE
Units: 2124631 and 2222404
RECALLING FIRM/MANUFACTURER
Medic Inc. Knoxville, TN, by facsimile on January 3, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0047-07;
b) Platelets, Recall # B-0048-07
CODE
a) Units: L61331 and L56722;
b) Units: L61331 and L61335
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on February 16, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA and TN

______________________________
PRODUCT
Dupaco Blood / Fluid Warming Set, Product Number: D25480, Recall # B-0360-07
CODE
Lot Numbers: 030603, 030603A, 030145 and 050244
RECALLING FIRM/MANUFACTURER
Dupaco, Inc., Oceanside, CA, by letter beginning October 11, 2006. Firm initiated recall is on going.
REASON
Blood / Fluid Warming Sets, that may leak, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Source Plasma, Recall # B-0447-07
CODE
Units: 32474756, 32471915, 32411027, 32407785, 32405316, 32403671
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile dated January 30, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose eligibility to donate was not completely assessed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0558-07
CODE
Unit: 8032887
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on August 31, 2005. Firm initiated recall is complete.
REASON
Blood product, collected using automated equipment that was not validated for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0614-07
CODE
Unit: 5619526 (part 1)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 29, 2006. Firm initiated recall is complete.
REASON
Blood product, which was identified as being contaminated by the BacT/ALERT system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0658-07
CODE
Units: 5670127 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone and facsimile on June 6, 2006. Firm initiated recall is complete.
REASON
Platelets, which were incorrectly labeled as leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0679-07;
b) Red Blood Cells, Rejuvenated, Washed, Recall # B-0680-07;
c) Red Blood Cells, Deglycerolized, Recall # B-0681-07;
d) Platelets, Recall # B-0682-07;
e) Platelets, Irradiated, Recall # B-0683-07;
f) Cryoprecipitate, AHF, Recall # B-0684-07;
g) Cryoprecipitate, Pooled, Recall # B-0685-07;
h) Plasma Cryoprecipitated Reduced, Recall # B-0686-07;
i) Fresh Frozen Plasma, Recall # B-0687-07
CODE
a) Units: 18GF42971, 18GF42973, 18GF42974, 18GF42975, 18GF42977, 18GF42979, 18GF42987, 18GG56741, 18GG56754, 18GG56760, 18GG56762, 18GG56767, 18GF42926, 18GF42929, 18GF42930, 18GF42935, 18GF42938, 18GF42945, 18GF42948, 18GF42950, 18GF42951, 18GF42953, 18GG56672, 18GG56676, 18GG56704, 18GG56713, 18GF42880, 18GF42884, 18GF42904, 18GF42906, 18GF42845, 18GF42849, 18GF42867, 18GF42794, 18GF42796, 18GF42821, 18GF42767, 18GF42771, 18GF42776, 18GF42779, 18GF42782, 18GF42788, 18GF42789, 18GG56528, 18GG56534, 18GG56535, 18GG56552, 18GG56555, 18GG56559, 18GG56564, 18GG56410, 18GG56422, 18GG56437, 18GG56440, 18GG56450, 18GF42682, 18GF42684, 18GF42689, 18GK28136, 18GK28137, 18GK28140, 18GK28141, 18GK28148, 18GK28154, 18GK28106, 18GK28108, 18GK28111, 18GK28116, 18GK28126, 18GK28045, 18GK28047, 18GK28048, 18GK28050, 18GK28064, 18GK28067, 18GK28071, 18GK28084, 18GK28086, 18GK28088, 18GK28089, 18GK28091, 18GK27962, 18GK27971, 18GK27972, 18GK27973, 18GK27975, 18GK27929, 18GK27941, 18GK27943, 18GK27948, 18GK56232, 18GG56233, 18GG56234, 18GG56238, 18GG56250, 18GG56253, 18GG56264, 18GG56265, 18GF42481, 18GF42492, 18GK27744, 18GK27750, 18GK27752, 18GK27753, 18GK27764, 18GK27711, 18GK27714, 18GK27715, 18GK27717, 18GK27718, 18GK27721, 18GK27723, 18GK27727, 18GK27728, 18GK27730, 18GG56014, 18GG56015, 18GG56022, 18GK27507, 18GK27513, 18GK27485, 18GK27486, 18GK27492, 18GK27474, 18GK27481, 18GK27484, 18GK27470, 18GH89842, 18GH89837, 18GH89839, 18GH89830, 18GH89833, 18GG55868, 18GG55852, 18GG55853, 18GG55862, 18GG55832, 18GG55848, 18GG55827, 18GG55829, 18GH89540, 18GH89535, 18GH89536, 18GH89529, 18GH89531, 18GH89532, 18GH89520, 18GH89522, 18GH89512, 18GH89515, 18GH89517, 18GH89510, , 18GK27236, 18GK27238, 18GK27240, 18GK27219, 18GK27221, 18GK27214, 18GK27133, 18GK27135, 18GK27104, 18GK27099, 18GK27100, 18GF41961, 18GF41956, 18GF41958, 18GF41960, 18GF41949, 18GF41950, 18GF41954, 18GF41946, 18GF41948, 18GF41929, 18GF41931, 18GG55334, 18GG55336, 18GG55348, 18GG55323, 18GG55331, 18GG55281, 18GG55283, 18GG55285, 18GG55292, 18GG55306, 18GK26710, 18GK26714, 18GK26719, 18GK26720, 18GK26731, 18GK26733, 18GK26739, 18GK26742, 18GK26743, 18GG55172, 18GG55189, 18GG55084, 18GG55090, 18GG55091, 18GG55099, 18GG55100, 18GG55103, 18GG55112, 18GG55114, 18GH88692, 18GH88695, 18GH88697, 18GH88707, 18GH88711, 18GH88713, 18GH88725, 18GH88727, 18GH88728, 18GH88730, 18GH88731, 18GH88733, 18GF41436, 18GF41449, 18GF41451, 18GH88653, 18GH88668, 18GH88673, 18GH88612, 18GH88619, 18GK26231, 18GK26233, 18GK26235, 18GK26239, 18GK26247, 18GK26249, 18GK26207, 18GF41245, 18GF41248, 18GF41260, 18GF41261, , 18GF41269, 18GF41271, 18GF41193, 18GF41196, 18GF41207, 18GF41178, 18GF41180, 18GH88080, 18GH88100, 18GH88127, 18GH88133, 18GH88136, 18GK25984, 18GK25986, 18GK25987, 18GK25991, , 18GK26004, 18GK26010, 18GH88005, 18GH87989, 18GH87986, 18GH87980, 18GG54273, 18GG54271, , 18GG54248, , 18GG54244, 18GH87840, 18GH87843, 18GH87848, 18GH87860, 18GH87865, 18GH87868, 18GH87870, 18GH87892, 18GF40937, 18GF40935, 18GF40933, 18GF40930, 18GK27762, 18GF40928. 18GF42865, 18GF42878, 18GF42781, 18GF42686, 18GF42687, 18GK28104, 18GK28149, 18GK28153, 18GK28072, 18GK27984, 18GG56251, 18GG56268, 18GG56270, 18GG56262, 18GG55864, 18GG55866, 18GG55831, 18GG55825, 18GH89534, 18GK27241, 18GK27243, 18GK27232, 18GK27102, 18GK27120, 18GF41939, 18GG55325, 18GK26730, 18GG55173, 18GG55085, 18GH88708, 18GH88710, 18GF41438, 18GF41452, 18GH88648, 18GH88650, 18GH88662, 18GH88664, 18GH88610, 18GH88624, 18GH88639, 18GK26232, 18GK26236, 18GK26237, 18GK26240, 18GK26248, 18GK26208, 18GK26219, 18GK26220, 18GK26224, 18GK26225, 18GF41246, 18GF41254, 18GF41268, 18GH88138, 18GK26002, 18GK26003, 18GH88001, 18GH87863, 18GG54270, 18GG54267, 18GG54251, 18GG54246, 18GH87972, 18GH87969, 18GH87966, 18GG54280, 18GG54278, and 18GH87986;
b) Unit: 18GG56264;
c) Unit: 18GG54248;
d) Units: 18GG56410, 18GK27962, 18GH88080, 18GH88100 and 18GH88102.
18GG56232, 18GG56233, 18GG56234, 18GG56240, 18GG56253;
e) Unit: 18GG56437;
f) Units: 18GK28111, 18GH89512, 18GH89515, 18GH87980, 18GH87860, 18GH87865,
18GK28118, 18GK28047, 18GG55848, 18GH89517, 18GH88102, 18GH87989,
18GH87972, 18GH87969, 18GH87966, 18GH87840, 18GH87843, and 18GH87863;
g) Unit: 18GK28050;
h) Units: 18GK28118, 18GH87989, 18GH87848;
i) 18GK28064, 18GG56232, 18GG56234, 18GG56236, 18GG56240, 18GG56015,
18GG56018, 18GG55323, 18GH88127, 18GH88001, 18GG54271, 18GG54270,
18GG54268, 18GH87870, and 18GG54273;
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on March 19, 2003 and March 20, 2003, by facsimile on March 28, 2003 and letter on April 2, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
390 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0690-07;
b) Plasma, Frozen, Recall # B-0691-07;
c) Recovered Plasma, Recall # B-0692-07
CODE
a) Units: 1602268, 1602070, 1601870;
b) Units: 1602268, 1602070;
c) Unit: 1601870
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated February 13, 2006. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor who was previously deferred for testing positive for Hepatitis C, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
OH and Austria

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0702-07
CODE
Units: W001305200533-AO
RECALLING FIRM/MANUFACTURER
Department of the Air Force – BB/HT, Lackland Air Force Base, TX, by telephone on October 30, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Propionibacterium acnes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
Source Plasma, Recall # B-0704-07
CODE
Units: 04STXA5508, 04STXA4472, 04STXA4244, 04STXA3661, 04STXA3394
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., San Antonio, TX, by facsimile transmission dated August 10, 2005, Firm initiated recall is complete.
REASON
Source Plasma, collected from a previously deferred donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA

______________________________
PRODUCT
Human Cornea for Transplantation, Recall # B-0705-07
CODE
Tissue: 05-0091-100
RECALLING FIRM/MANUFACTURER
Oklahoma Lions Eye Bank, Oklahoma City, OK, by telephone on January 17, 2006 and by letter dated January 25, 2006. Firm initiated recall is complete.
REASON
Human Cornea, recovered from a septic donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
GA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0707-07
CODE
N47930 (split unit)
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by facsimile on October 9, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Plavix, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0708-07
CODE
Unit: 038FX11057
RECALLING FIRM/MANUFACTURER
American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on October 2, 2006. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect radiation indicator, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0711-07
CODE
Unit: 3100673
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on October 9, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with coagulase negative Staphylococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0044-07
CODE
Unit: 033GV85448
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by telephone on August 25, 2006 and a follow-up letter on August 26, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an incorrect documented body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CT

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0046-07
CODE
Units: T13861, E59495, M35647, E58729, and E61076
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford, Il, by telephone on August 29, 2006. Firm initiated recall is complete.
REASON
Blood products, which were not frozen within the appropriate time frame following collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
IL and IA

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0610-07;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-0611-07
CODE
a) Unit: 5219870;
b) Unit: 4997227
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on November 23, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY and AZ

______________________________
PRODUCT
a) Red Blood Cells, (for further manufacture-non-injectable), Recall # B-0688-07;
b) Recovered Plasma, Recall # B-0689-07
CODE
a) Unit: 18GK27222;
b) Units: 18GG56718, 18GG56734, 18GG56736, 18GG56739, 18GG56741, 18GG56743, 18GG56757, 18GG56760, 18GG56762, 18GF42926, 18GF42929, 18GF42930, 18GF42931, 18GF42935, 18GF42938, 18GF42944, 18GF42945, 18GF42947, 18GF42948, 18GF42950, 18GF42951, 18GF42953, 18GG56657, 18GG56661, 18GG56663, 18GG56665, 18GG56668, 18GG56672, 18GG56676, 18GG56684, 18GG56687, 18GG56704, 18GG56707, 18GG56708, 18GG56711, 18GG56713, 18GF42880, 18GF42881, 18GF42883, 18GF42884, 18GF42904, 18GF42906, 18GF42845, 18GF42847, 18GF42849, 18GF42865, 18GF42867, 18GF42878, 18GF42879, 18GF42794, 18GF42796, 18GF42809, 18GF42821, 18GF42767, 18GF42769, 18GF42771, 18GF42776, 18GF42778, 18GF42779, 18GF42781, 18GF42782, 18GF42783, 18GF42787, 18GF42788, 18GF42789, 18GG56528, 18GG56534, 18GG56535, 18GG56552, 18GG56555, 18GG56559, 18GG56564, 18GG56410, 18GG56422, 18GG56440, 18GG56450, 18GG56451, 18GF42682, 18GF42684, 18GF42686, 18GF42687, 18GF42689, 18GK28136, 18GK28137, 18GK28140, 18GK28141, 18GK28148, 18GK28149, 18GK28153, 18GK28154, 18GK28104, 18GK28106, 18GK28108, 18GK28110, 18GK28111, 18GK28116, 18GK28126, 18GK28045, 18GK28047, 18GK28048, 18GK28050, 18GK28067, 18GK28069, 18GK28071, 18GK28072, 18GK28083, 18GK28084, 18GK28086, 18GK28088, 18GK28089, 18GK28091, 18GK27961, 18GK27962, 18GK27971, 18GK27972, 18GK27973, 18GK27975, 18GK27984, 18GK27929, 18GK27941, 18GK27943, 18GK27948, 18GG56233, 18GG56238, 18GG56250, 18GG56251, 18GG56253, 18GG56262, 18GG56264, 18GG56265, 18GG56268, 18GG56270, 18GF42481, 18GF42492, 18GF42493, 18GK27744, 18GK27750, 18GK27752, 18GK27753, 18GK27761, 18GK27762, 18GK27764, 18GK27711, 18GK27714, 18GK27715, 18GK27717, 18GK27718, 18GK27721, 18GK27723, 18GK27727, 18GK27728, 18GK27730, 18GG56014, 18GG56022, 18GK27497, 18GK27499, 18GK27507, 18GK27513, 18GK27485, 18GK27486, 18GK27492, 18GK27474, 18GK27481, 18GK27484, 18GK27470, 18GH89842, 18GH89843, 18GH89837, 18GH89839, 18GH89830, 18GH89833, 18GG55864, 18GG55866, 18GG55868, 18GG55852, 18GG55853, 18GG55862, 18GG55832, 18GG55848, 18GG55850, 18GG55827, 18GG55829, 18GG55831, 18GG55825, 18GH89540, 18GH89534, 18GH89535, 18GH89536, 18GH89529, 18GH89531, 18GH89532, 18GH89520, 18GH89522, 18GH89512, 18GH89515, 18GH89517, 18GK27241, 18GK27243, 18GK27236, 18GK27238, 18GK27240, 18GK27222, 18GK27224, 18GK27232, 18GK27219, 18GK27221, 18GK27214, 18GK27133, 18GK27135, 18GK27137, 18GK27102, 18GK27104, 18GK27120, 18GK27099, 18GK27100, 18GF41961, 18GF41956, 18GF41958, 18GF41960, 18GF41949, 18GF41950, 18GF41954, 18GF41939, 18GF41946, 18GF41948, 18GF41929, 18GF41931, 18GG55334, 18GG55336, 18GG55348, 18GG55325, 18GG55331, 18GG55283, 18GG55285, 18GG55292, 18GG55306, 18GK26710, 18GK26712, 18GK26714, 18GK26719, 18GK26720, 18GK26730, 18GK26731, 18GK26733, 18GK26739, 18GK26742, 18GK26743, 18GG55172, 18GG55173, 18GG55189, 18GG55084, 18GG55085, 18GG55090, 18GG55091, 18GG55099, 18GG55100, 18GG55103, 18GG55112, 18GG55114, 18GH88692, 18GH88695, 18GH88697, 18GH88707, 18GH88708, 18GH88710, 18GH88711, 18GH88713, 18GH88725, 18GH88727, 18GH88728, 18GH88730, 18GH88731, 18GH88733, 18GF41436, 18GF41438, 18GF41449, 18GF41451, 18GF41452, 18GH88650, 18GH88651, 18GH88653, 18GH88662, 18GH88664, 18GH88668, 18GH88673, 18GH88610, 18GH88612, 18GH88619, 18GH88624, 18GH88639, 18GK26231, 18GK26232, 18GK26233, 18GK26235, 18GK26237, 18GK26239, 18GK26240, 18GK26247, 18GK26248, 18GK26249, 18GK26207, 18GK26208, 18GK26219, 18GK26220, 18GK26224, 18GK26225, 18GF41245, 18GF41246, 18GF41248, 18GF41254, 18GF41260, 18GF41261, 18GF41268, 18GF41269, 18GF41271, 18GF41193, 18GF41196, 18GF41207, 18GF41178, 18GF41179, 18GF41180, 18GH88080, 18GH88100, 18GH88102, 18GH88133, 18GH88136, 18GH88138, 18GK25986, 18GK25987, 18GK25991, 18GK26002, 18GK26003, 18GK26004, 18GK26010, 18GH88005, 18GH87986, 18GH87980, 18GH87972, 18GH87969, 18GH87966, 18GG54280, 18GG54278, 18GG54267, 18GG54253, 18GG54251, 18GG54248, 18GG54246, 18GG54244, 18GH87840, 8GH87843,18GH87860, 18GH87863, 18GH87865, 18GH87868,18GH87892, 18GF40937, 18GF40935, 18GF40933, 18GF40930 and 18GF40928
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on March 20, 2003, by facsimile on March 28, 2003 and by letter on April 2, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
359 units
DISTRIBUTION
NB and Switzerland

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0693-07
CODE
Units: 030GE46801, 030GE46802, 030GE46804, 030GE46805, 030GE46806, 030GE46807, 030GE46808, 030GE46809, 030GE46810, 030GE46811, 030GE46812, 030GE46813, 030GE46814, 030GE46816, 030GE46817, 030GE46818, 030GE46819, 030GE46820, 030GE46821, 030GE46822, 030GE46823, 030GE46824, 030GE46825, 030GE46826, 030GE46827
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by letter dated October 3, 2006. Firm initiated recall is complete.
REASON
Blood products, collected on trip scales for which documentation of the daily quality control testing was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
MD, NY, PA, VA, and D.C.

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0701-07
CODE
Units: 5487341 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on October 17, 2005. Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced, but had an unacceptable white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK

______________________________
PRODUCT
Fluvirin (Influenza Virus Vaccine), Purified Surface Antigen Vaccine 2006-2007 Formulation Sterile suspension 5mL; NDC Number: 66521-109-10, Recall # B-0703-07
CODE
Lot Numbers: 71209 and 71210 (exp. 6/30/07)
RECALLING FIRM/MANUFACTURER
Chiron Vaccines, Liverpool, UK, by facsimile dated October 20, 2006. Firm initiated recall is complete.
REASON
Influenza Vaccine, lacking assurance of proper storage temperatures during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
48, 385 vials
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0712-07
CODE
Unit: 3100768
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on November 9, 2006 and by letter dated December 22, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

______________________________
PRODUCT
Source Plasma, Recall # 0713-07
CODE
Unit: 05KTNA7772
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corp., Knoxville, TN, by facsimile on January 18, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0714-07
CODE
Units: 05KTNA4082, 05KTNA3313, 05KTNA3140, 05KTNA2869, 05KTNA2784, 05KTNA2607, 05KTNA2518, 05KTNA2335, 05KTNA2223, 05KTNA2102, 05KTNA1998, 05KTNA1679, 05KTNA0894, 05KTNA0763, 05KTNA0520, 05KTNA0181, 05KTNA0072, 04KTNA1414, 04KTNA1297, 04KTNA0995, 04KTNA0890, 04KTNA0671, 04KTNA0583, 04KTNA0340, 04KTNA0284, 04KTNA0060, 20670528, 19818573, 19817941, 19815411, 19814872, 19812779, 19811147, 19810249, 19808635, 19807508, 19805634, 19804712, 19803050, 19801919, 19258850, 19257907, 19256221, 19255187, 19253206, 19252247, 19010519, 19009124, 19006765, 19005478, 19003924, 19002750, 18960228, 18959222, 18956924, 18955880, 18954630, 18953190, 18951486, 09980303, 09976832, 09975750, 09973787, 09972834, 09970915, 10290309, 10288627, 10287248, 10285589, 10284018, 10282847, 10281581, 08899453, 08898678, 08892942, 08892003
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corp., Knoxville, TN, by facsimile on August 10, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
76 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0715-07
CODE
Units: 04KTNA0750, 04KTNA0341, 04KTNA0174, 04KTNA0084, 19818580, 19815381, 19812809, 19810218, 19808604, 19807904, 19801575, 19257914, 19256207, 19255170, 19253268, 19252278
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corp., Knoxville, TN, by facsimile on August 10, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0716-07
CODE
Units: 06905392, 06904463, 05030095, 05028467, 05027248, 04826729, 04825715, 04824015
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corp., Knoxville, TN, by facsimile on August 9, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA

______________________________
PRODUCT
Source Plasma, Recall # B-0717-07
CODE
Units: 04KTNA0750, 04KTNA0341, 04KTNA0174, 04KTNA0084, 19818580, 19815381, 19812809, 19810218, 19808604, 19807904, 19801575, 19257914, 19256207, 19255170, 19253268, 19252278
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corp., Knoxville, TN, by facsimile on August 9, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0718-07
CODE
Units: 04878049, 04873815, 04873136, 04827412
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corp., Knoxville, TN, by facsimile on August 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0719-07
CODE
Units: 06879419, 06877125, 06876173, 06874209, 06873400
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corp., Knoxville, TN, by facsimile on August 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0720-07
CODE
Units: 05KTNA0844, 05KTNA0525, 05KTNA0180, 04KTNA1359, 04KTNA1166
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corp., Knoxville, TN, by facsimile on August 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0721-07
CODE
Units: 06877552, 06876432, 06872649, 06850197, 06849498, 06847807, 06845162
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corp., Knoxville, TN, by facsimile on August 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0722-07
CODE
Units: 05021871, 04879954, 04879398, 04876991, 04876618, 04875055, 04874454, 04872931, 04871507
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corp., Knoxville, TN, by facsimile on August 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0723-07
CODE
Units: 04824039, 04822592, 04820871, 05699964, 05698363, 05697625, 05695669, 05694747, 05693924
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corp., Knoxville, TN, by facsimile on August 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0724-07
CODE
Units: 05KTNA3723, 05KTNA3610, 05KTNA3310, 05KTNA3136, 05KTNA3093, 05KTNA2866, 05KTNA2514, 05KTNA2331, 05KTNA1962, 05KTNA1445, 05KTNA1260, 05KTNA1124
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corp., Knoxville, TN, by facsimile on August 9, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CA

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0725-07;
b) Fresh Frozen Plasma, Recall # B-0726-07
CODE
a) and b) Unit: 06LN47825
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by telephone on February 2, 2005, by follow-up letter dated February 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose vital signs were not properly determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

___________________________________
PRODUCT
a) Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle.
To attach mesh to the abdominal wall. Reference Number 0113036 or
9113036 (refurbished), Recall # Z-0374-2007;
b) Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle.
To attach mesh to the abdominal wall. Reference Number 0113037 or 9113037
(refurbished), Recall # Z-0375-2007
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Cranston, RI, by letter on December 27, 2006.
Manufacturer: Bard Shannon Limited, Humacao, PR. Firm initiated recall is ongoing.
REASON
Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing.
VOLUME OF PRODUCT IN COMMERCE
4,787 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog number 801046, Recall # Z-0381-2007
CODE
Serial numbers: 0119, 0123, 0124, 0128, 0135, 0136, 0139, 0140, 0146, 0147, 0148, 0151, 0152, 0157, 0171, 0196, 0197, 0214, 0232, 0241, 0271, 0305, 0310, 0315, 0316, 0318, 0323, 0345, 0346, 0372, 0375, 0376, 0377, 0378 and 0380
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone, fax, email or by visit between November 8, 2006 and November 13, 2006. Firm initiated recall is complete.
REASON
Following installation of software version 1.30 in October 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and caused the pump to stop during clinical use and a ''connect motor'' message to be displayed.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
a) ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter –
Reference Number 23242, Recall # Z-0390-2007;
b) ACS DUOSTAT® Rotating Hemostatic Valve, 0.096 inch, for use with a
dilatation catheter - Reference Number 23244, Recall # Z-0391-2007
CODE
a) 6090751, 6090752, 6091151, 6091152;
b) 6090551
RECALLING FIRM/MANUFACTURER
Abbott Vascular-Cardiac Therapies dba Guidant Corp., Temecula, CA, by letter on December 5, 2006. Firm initiated recall is ongoing.
REASON
Specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch.
VOLUME OF PRODUCT IN COMMERCE
3,153 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the
prevention of recurrent pulmonary embolism. Catalog Number RF-320J,
Recall # Z-0393-2007;
b) Recovery G2 Filter System - Jugular/Subclavian Delivery Kit, for use in
the prevention of recurrent pulmonary embolism. Catalog Number RF-220J
***For Canada & Australia only***, Recall # Z-0394-2007
CODE
Lot numbers: GFPK4733, GFPK4734, GFPL4229, GFPL4230, GFPL4231,
GFQA1497, GFQA1498, GFQA1499, GFQA1500, GFQA1501, GFQA1502,
GFQA1503, GFQA1504, GFQA1505, GFQA1506, GFQA2794, GFQA2795,
GFQA2796, GFQA2797, GFQA2798, GFQA2994, GFQA2995, GFQA2996,
GFQA2997, GFQA2998, GFQA2999, GFQB1909, GFQB1910, GFQB1911,
GFQB1912, GFQB1913, GFQB1914, GFQB1915, GFQB1916, GFQC1489,
GFQC1490, GFQC1491, GFQC3088, GFQC3089, GFQC3090, GFQD0153,
GFQD0154, GFQD0155, GFQD0156, GFQD0157, GFQD0158, GFQD0159,
GFQD0160, GFQD2046, GFQD2047, GFQD2048, GFQD3730, GFQD3731,
GFQD3732, GFQD3733, GFQD3734, GFQD3735, GFQD3736, GFQD3737,
GFQE4635, GFQE4636, GFQF0398, GFQF0399, GFQF0626, GFQF0627,
GFQF3344, GFQF3345, GFQF3346, GFQF3348, GFQF3349, GFQF3350,
GFQF4295, GFQF4298, GFQF4299, GFQF4300, GFQG2804, GFQG3632,
GFQG3633, GFQG4404, GFQH1231, GFQH1232, GFQH1233, GFQH1234,
GFQH1235, GFQH3834, GFQH3835, GFQH3836, GFQI0220, GFQI0221,
GFQI0222, GFQI0223, GFQI0224, GFQI0225, GFQI0226, GFQI0227,
GFQI0228, GFQI3991, GFQI3993 & GFQI3996;
b) Lot numbers: GFPK3279, GFPK3280, GFPK3281 & GFPK3282
RECALLING FIRM/MANUFACTURER
Bard Peripheral Vascular, Inc., Tempe, AZ, by letters on December 20, 2006. Firm initiated recall is ongoing.
REASON
This action is being taken because BPV has recently received three complaints for the device that involve reports of introducer sheath tip damage. The damage may result in loss of tip integrity.
VOLUME OF PRODUCT IN COMMERCE
5,885 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Boston Scientific brand iLab™ Ultrasound Imaging System, for intravascular use; Model Number(s): iLab120lNS, iLab2401NS, Recall # Z-0395-2007
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Boston Scientific Target, Fremont, CA, by letter on December 1, 2006. Firm initiated recall is ongoing.
REASON
The product fails to comply with applicable electronic product performance standard, in that the electromagnetic energy is in excess of the labeled conformance standards for radiated emissions.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
Nationwide and Portugal

___________________________________
PRODUCT
Portrait® PSR3 System, an electro-surgical device used in dermatological applications, Recall # Z-0397-2007
CODE
Software versions prior to Version V2.0A
RECALLING FIRM/MANUFACTURER
Rhytec, Inc., Waltham, MA, by letter dated October 2, 2006. Firm initiated recall is ongoing.
REASON
Inadequate Directions for Use: Software Upgrade to set maximum pulse rate to 2.5 Hz.
VOLUME OF PRODUCT IN COMMERCE
234 units
DISTRIBUTION
Canada, Australia, Brazil, and Korea

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

___________________________________
PRODUCT
ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120, Recall # Z-0389-2007
CODE
Lot: 1772812
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, by letter on December 6, 2006. Firm initiated recall is complete.
REASON
Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL, PA

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________
PRODUCT
Bulk Darling's 85% Blood Meal, Flash Dried, distributed in totes and in 1-ton bags (for one customer only), Recall # V-012-2007
CODE
Blood meal distributed between 9/7/2006-2/3/2007.
RECALLING FIRM/MANUFACTURER
Darling National LLC, Omaha, NB, by telephone on January 12, 2007. Firm initiated recall is ongoing.
REASON
Some of the exempt bovine blood meal was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and the labeling did not bear the cautionary BSE statement that it should not be fed to ruminants.
VOLUME OF PRODUCT IN COMMERCE
1,366,128 lbs.
DISTRIBUTION
WI, TX, NE, TN, CO, and MN

END OF ENFORCEMENT REPORT FOR FEBRUARY 7, 2007

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