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U.S. Department of Health and Human Services

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Enforcement Report for April 23, 2008

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.

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April 23 , 2008
08-17

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Sanford Limited Sustainable Seafood MSG4804073 Mussel Meat Perna canaliculus IQF 2 10 x 1kg Net weight 10.00Kg/22.05Lb, Recall # F-281-8
CODE
Lot #184366-1 From Pack House (PH) 177 with production date of any day during the time period of May 23 through November 21, 2007.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pacific American Fish Co Inc., Vernon, CA, by fax on November 29, 2007.
Manufacturer: Sanford Ltd Auckland, Auckland, New Zealand. Firm initiated recall is complete.
REASON
Product potentially contaminated with Listeria monocytogenes based on information received from foreign manufacturer.
VOLUME OF PRODUCT IN COMMERCE
944 cases
DISTRIBUTION
CA, HI, AZ, MO, CO, NV, TX, TN
___________________________________
PRODUCT
Mike's Melons brand Whole Cantaloupes. The product is sold in brown cardboard cartons containing either 9 or 12 melons, Recall # F-282-8
CODE
All products shipped from 3/1/08 through 3/20/08. The product is not coded
RECALLING FIRM/MANUFACTURER
Recalling Firm: T.M. Kovacevich International, Philadelphia, PA, by telephone on March 21 – 24, 2008 and by press release on March 25, 2008.
Manufacturer: Agropecuaria Montelibano, Valle, Honduras. Firm Initiated recall is ongoing.
REASON
Cantaloupes imported from a Honduran firm, have been associated with an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
8,720 cartons
DISTRIBUTION
FL, GA, NJ and MA
__________________________________
PRODUCT
a) Onion Crock brand Old Fashioned Potato Soup in 1, 4, and 8 lb. clear plastic pouches,
keep frozen. The 1 lb is labeled for retail sale. The 4 and 8 lb packs are sold only for
institutional use, Recall # F-283-8;
b) Onion Crock brand Minestrone Soup in 1, 4, and 8 lb clear plastic pouches, keep
frozen. The 1 lb is labeled for retail sale. The 4 and 8 lb packs are sold only for
institutional use. Recall # F-284-8
CODE
a) All lots with a use by date of on or before 07/21/2009;
b) All lots with a use by date of on or before 07/08/2009
RECALLING FIRM/MANUFACTURER
Onion Crock Of Michigan, Grand Rapids, MI, by press release and telephone on February 8, 2008. Firm initiated recall is complete.
REASON
Soup contains undeclared soy and wheat.
VOLUME OF PRODUCT IN COMMERCE
4,565 packages
DISTRIBUTION
MI

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
L’Oreal Paris Dream Blonde, Complete Bleach & Lightening System, Baby’s Breath Blonde 100 Ultra Lightening with UPC 0 71249 13925 7. SKU number 7A07111. Product comes in a carton containing a kit for one application. Recall # F-285-8
CODE
All lots of product.
RECALLING FIRM/MANUFACTURER
L'Oreal USA, Clark, NJ, by press release on January 18, 2008. Firm initiated recall is ongoing.
REASON
Product bears incorrect directions for use of bleach component which may lead to scalp irritation.
VOLUME OF PRODUCT IN COMMERCE
38,000
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
a) The finished product label stated in its entirety "Eye Drops Caution: Do Not Use
With Implants" in .22 oz bottle. This is a light amber colored liquid in a plastic
dropper bottle, Recall # D-197-2008;
b) The finished product label states in its entirety: "Eye/Ear Wash". It is light amber
colored liquid in a plastic dropper bottle, Recall # D-198-2008
CODE
No codes
RECALLING FIRM/MANUFACTURER
Nucel Lab Inc., Idaho Falls, ID, by letter on January 25, 2008 and by telephone on January 31, 2008. Firm initiated recall is ongoing.
REASON
Non Sterile
VOLUME OF PRODUCT IN COMMERCE
500 bottles
DISTRIBUTION
ID, IN

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Cefdinir for Oral Suspension, 3 gm, 250 mg/5mL after reconstitution, 60 mL when reconstituted, Rx only, NDC 0093-4137-64, Recall # D-199-2008
CODE
Lot 72225, exp. 03/31/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on March 27, 2008.
Manufacturer: Teva Pharmaceuticals USA, Inc., Fairfield, NJ. Firm initiated recall is ongoing.
REASON
Product failed assay specification on 10th day of reconstitution when tested at 9 months.
VOLUME OF PRODUCT IN COMMERCE
21,525 bottles
DISTRIBUTION
TN

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1072-08
CODE
Unit: LL84167 – Part 2
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by telephone on October 26, 2007. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus cereus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
RI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1086-08
CODE
Unit: 5004923
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Scarborough, ME, by letter on December 27, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets, Recall # B-1102-08
CODE
Unit: K28585
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on August 24, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell unit that contained a clot, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Source Plasma, Recall # B-1107-08
CODE
Unit: 377041904
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Anderson, IN, by facsimile on June 13, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had not had an annual physical performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1109-08
CODE
Units: 04FH02001 (part 3), 04FH02003 (part 3), 04FH02007 (part 3), 04FH02012 (part 3), 04FH02021 (part 3), 04FH02026 (part 3), 04FH02028 (part 3), 04FH02032 (part 3), 04GJ26797 (part 3), 04GJ26864 (part 3), 04GJ26870 (part 3), 04GJ26885 (part 3), 04GJ26923 (part 3), 04GJ26995 (part 3), 04GJ27194 (part 3)
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by facsimile and letter on August 28, 2005 and August 29, 2005. Firm initiated recall is complete.
REASON
Platelets, lacking appropriate quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
MA
___________________________________
PRODUCT
Source Plasma, Recall # B-1112-08
CODE
Unit: 377035715
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Anderson, IN, by facsimile on May 4, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had not had an annual physical performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1122-08
CODE
Unit: 0247162
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by electronic mail on August 15, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Red Blood Cells Deglycerolized, Recall # B-1126-08
CODE
Units: 5587095, 6456773
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone on November 8, 2007 and February 11, 2008. Firm initiated recall is complete.
REASON
Blood products, which may not have been prepared in accordance with specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1127-08
CODE
Unit: 72C287441 (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on June 25, 2007.
Manufacturer: LifeSouth Community Blood Centers, Inc., Huntsville, AL. Firm initiated recall is complete.
REASON
Blood products, with insufficient plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Source Plasma, Recall # B-1128-08
CODE
Units: 4260121910, 4260120669, 4260120273, 4260118970, 4260117783, 4260116796, 4260116368, 4260115486, 4260114711, 4260114320, 4260113171, 4260112855, 4260101319, 4260100753, 4260100158, 4260099740, 4260098989, 4260098455, 4260097718, 4260097439, 4260096788, 4260096382, 4260094914, 4260094362, 4260093627; 4260130253, 4260129805, 4260128270, 4260127956, 4260126242, 4260125759, 4260124557, 4260124163
RECALLING FIRM/MANUFACTURER
ZLB Plasma, Rock Island, IL, by fax on August 14, 2007. Firm initiated recall is complete.
REASON
Blood products, collected using an abbreviated screening process for which the donor was not eligible, were distributed
VOLUME OF PRODUCT IN COMMERCE
33 units
DISTRIBUTION
IL, IN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1130-08
CODE
Units: 032GF80084, 032GF80085, 032GF80086, 032GF80087, 032GF80088, 032GF80092, 032GF80095, and 032GF80096
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by telephone and facsimile on April 29, 2005 and April 30, 2005, and by letter dated May 3, 2005. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA, GA, IL, MA, ME, MI, PR, VA, WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1139-08
CODE
Units: 032GE67986, 032GE67989, 032GE68005, 032GF68996, 032GM21467, 032GM21471, 032GN15305, 032GN15347, 032GN15355, 032KC45903, 032KC45911, 032KR36365, 032KS19508, 032KV36280, 032KV36292, 032LX64875, 032LX64883, 032LX64983, 032LX64987, 032LX64990, 032LX65144
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by facsimile on March 3, 2005 and March 4, 2005. Firm initiated recall is complete.
REASON
Blood products, in which the sample tubes for viral marker testing were not maintained at an appropriate temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
GA, IL, WI
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1140-08
CODE
Unit: 307465992
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on April 4, 2005.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, which failed Red Blood Cell QC testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1152-08;
b) Fresh Frozen Plasma, Recall # B-1153-08;
c) Platelets Leukocytes Reduced, Recall # B-1154-08
CODE
a), b) and c) Unit: 22FS54005
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on November 14, 2007 and by follow-up letter dated November 14, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding a history of multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ, PA, VA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1156-08;
b) Platelets Leukocytes Reduced, Recall # B-1157-08
CODE
a) and b) Unit: 22GS28387
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on November 28, 2007, electronic notification on November 29, 2007, or by letter dated November 30, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1158-08;
b) Cryoprecipitated AHF, Recall # B-1159-08
CODE
a) and b) Unit: 22KR50724
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on December 5, 2007 and by letter dated December 17, 2007. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor who tested repeat reactive for the antibody to hepatitis B core antigen (HBc) on two occasions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Human Corneas, Recall # B-0938-08
CODE
Units: FJ20070121, FJ20070122
RECALLING FIRM/MANUFACTURER
The National Eye Bank Center, Memphis, TN, by telephone on January 12, 2007 and emails. Firm initiated recall is complete.
REASON
Human Corneal tissues, possibly recovered from a donor who tested repeatedly reactive for antibodies to the hepatitis C virus and mislabeled, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
MD, Damascus, Syria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0941-08
CODE
Unit: 71S471696
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile dated July 6, 2006. Firm initiated recall is complete.
REASON
Blood product, manufactured from Whole Blood that lacked the assurance of storage at the correct temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1032-08
CODE
Unit: 5999333
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on July 10, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled as negative for the Fyb antigen, but was collected from a donor who subsequently tested positive for Fyb antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Source Plasma, Recall # B-1053-08
CODE
Unit: 04PWIG2172
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on December 20, 2004.
Manufacturer: BioLife Plasma Services, Stevens Point, WI. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after the donor provided information concerning a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Leukocytes Reduced, Recall # B-1063-08
CODE
Unit: 033GL72126
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on April 27, 2007 and by letter dated May 4, 2007. Firm initiated recall is complete.
REASON
Blood product, prepared from a unit of Whole Blood which may have exceeded the acceptable collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CT
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1131-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1132-08;
c) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1133-08;
d) Platelets Leukocytes Reduced, Recall # B-1134-08;
e) Fresh Frozen Plasma, Recall # B-1135-08
CODE
a) 032KT68659 032KT68661 032KT68664 032KT68667 032KT68668 032KT68671
032KT68675 032KT68677 032KT68678 032KT68679 032KT68680 032KT68681
032KT68682 032KT68683 032KT68684 032KT68686 032KT68687 032KT68689
032KT68698 032KT68703 032KT68708;
b) Units: 032FC68122, 032FC68128, 032FC68130, 032FC68131, 032FC68132,
032FC68133, 032FC68137, 032GC29916, 032GC29917, 032GC29922, 032GC29925,
032GC29926, 032GC29927, 032GC29928, 032GC29930, 032GC29931,
032GC29932, 032GC29933, 032KL19586, 032KL19594, 032KL19597, 032KL19598,
032KL19601, 032KL19606, 032KR38619, 032KR38620, 032KR38621, 032KR38622,
032KR38623, 032KR38625, 032KR38629, 032KR38632, 032KR38634,
032KR38635, 032KR38636, 032KR38640, 032KR38645, 032KR38646,
032KR38647, 032KR38651, 032KR38655, 032KR38657, 032KR38660,
032KR38662, 032KR38664, 032KR38665, 032KR38667, 032KR38669,
032KR38670, 032KV38764, 032KV38768, 032KV38773, 032KV38776,
032KV38778, 032KX13610, 032KX13611, 032KX13612, 032KX13613,
032KX13614, 032KX13616, 032KX13619, 032KX13625, 032KX13626,
032KX13628, 032KX13631, 032KX13633, 032KX13635, 032KX13636,
032KX13637, 032KX13641, 032KX13643, 032KX13647, 032KX13650,
032KX13653, 032LX67413, 032LX67414, 032LX67417, 032LX67421,
032LX67422, 032LX67424, 032LX67425, 032LX67427, 032LX67430,
032LX67432, 032LX67433, 032LX67434, 032LX67435, 032LX67436,
032LX67437, 032LX67438, 032LX67439, 032LX67440, 032LX67444,
032LX67445, 032LX67446, 032LX67448, 032LX67449, 032LX67452,
032LX67454, 032LX67455, 032LX67456, and 032LX67458;
c) Units: 032KT68643, 032KT68645, 032KT68646, 032KT68647, 032KT68648,
032KT68649 (split unit), 032KT68650, 032KT68651, 032KX13596 (split unit),
032KX13597, 032KX13598 (split unit), 032KX13600, 032LX67394 (split unit),
032LX67395 (split unit), 032LX67396, 032LX67397, 032LX67398 (split unit),
032LX67399 (split unit), 032LX67400 (split unit), 032LX67404 (split unit),
032LX67405 (split unit), 032LX67406 (split unit), and 032LX67408 (split unit).
d) Units: 032KL19587, 032KL19588, 032KL19589, 032KL19591, 032KL19592,
032KL19593, 032KL19598, 032KL19600, 032KR38623, 032KR38626, 032KR38627,
032KR38628, 032KR38630, 032KR38631, 032KR38634, 032KR38635,
032KR38638, 032KR38644, 032KR38649, 032KR38650, 032KR38652,
032KR38659, 032KR38663, 032KR38666, 032KR38667, 032KR38671, and
032KR38672;
e) Units: 032KL19595, 032KL19603, 032KR38624, 032KR38656, and 032KR38657
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by telephone and facsimile on April 29, 2005 and April 30, 2005, and by letter dated May 3, 2005. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
190 units
DISTRIBUTION
CA, GA, IL, MA, ME, MI, PR, VA, WI
___________________________________
PRODUCT
a) Fresh Frozen Plasma (Apheresis), Recall # B-1142-08;
b) Platelets, Pheresis Leukocytes Reduced, Irradiated, Recall # B-1143-08
CODE
a) Unit: N72420;
b) Units: N72420 (2 units)
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on October 19, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a bone graft within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI
___________________________________
PRODUCT
a) Recovered Plasma, Recall# B-1144-08;
b) Red Blood Cells, Recall # B-1145-08
CODE
a) and b) Unit: Q80218
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by facsimile or electronic notification on October 9, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a bone graft within six months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1146-08;
b) Platelets, Recall # B-1147-08;
c) Fresh Frozen Plasma, Recall # B-1148-08
CODE
a), b) and c) Unit: F90924
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on November 16, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a skin graft within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1149-08;
b) Platelets, Recall # B-1150-08;
c) Fresh Frozen Plasma, Recall # B-1151-08
CODE
a), b) and c) Unit: F49028
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on December 7, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received a tendon transplant within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1155-08
CODE
Unit: 22GS28387
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on November 28, 2007, electronic notification on November 29, 2007, or by letter dated November 30, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Recall # Z-0575-2008
CODE
All software version 2.0, used with Calibrator Lots 86280 and 86290
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Hercules, CA, by letter dated November 1, 2007, by telephone on November 13, 2007, followed up by facsimile and e-mail. Firm initiated recall is ongoing.
REASON
Incorrect values: An error was found in the BioPlex 2200 Software, Version 2.0 that results in assignment values being utilized for the BioPlex assay Calibrator Set that may be slightly different from those printed on the Value Assignment Data Sheet. Some values may be identical between the lot assignment combinations with the ANA Screen with MDSS kit.
VOLUME OF PRODUCT IN COMMERCE
85 units of calibrator lot 86280 and 16 units of calibrator lot 86290
DISTRIBUTION
Nationwide, Canada, France, and Germany
___________________________________
PRODUCT
Stryker GMRS Proximal Femoral Surgical Protocol; Global Modular Replacement System Proximal Femoral Resection for Large Segmental Replacements, Femur Prosthesis Surgical Literature, Recall # Z-0668-2008
CODE
Literature number: LSPK41; 10 surgical protocols per package.
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp, Mahwah, NJ, by letters on December 21, 2007 and January 7, 2008. Firm initiated recall is ongoing.
REASON
The GMRS Proximal Femoral Surgical Protocol states " The GMRS Proximal Femoral components are fully compatabile with all Stryker V40 femoral heads." This statement is incorrect and conflicts with the Alumina Head label and packaging insert.
VOLUME OF PRODUCT IN COMMERCE
5,869,
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR.,
15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long.
Accepts devices up to 7.0 French, sterile; Catalog Number: C-PLI-7.0-35.
Recall # Z-0892-2008;
b) Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR.,
15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needles: 18 ga., 7.0 cm long.
Accepts devices up to 7.0 French, sterile; Catalog Number: C-PLI-7.0-35-X-1,
Recall # Z-0893-2008;
c) Peel-Away Introducer set, Catheter introducer, sterile; Catalog Number:
C-PLI-7.0-38-CPC-072491, Recall # Z-0894-2008;
d) Minipuncture Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath:
7.0 FR., 9 CM long, Wire: .025" DIA., 30 CM long, 3 MM J needle: 20XT GA., 4.0
cm long. Accepts devices up to 7.0 French, sterile; Catalog Number: C-PLIP-7.0-25-
E-MNP, Recall # Z-0895-2008;
e) Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer,
9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long.
Accepts devices up to 7.0 French, sterile; Catalog Number: C-PLIP-7.0-35,
Recall # Z-0896-2008;
f) Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR.,
15.5 CM long, Wire: .035" DIA., 50 CM long. Accepts devices up to 7.0 French,
sterile; Catalog Number: C-PLV-7.0-35, Recall # Z-0897-2008;
g) Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR.,
15.5 CM long, Wire: .038" DIA., 50 CM long, straight. Accepts devices up to 7.0
French, sterile; Catalog Number: C-PLV-7.0-38, Recall # Z-0898-2008;
h) Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter
introducer, Accepts devices up to 7.0 French., sterile; Catalog Number: PLVW-7.0-35,
Recall # Z-0899-2008;
i) Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer,
Accepts devices up to 7.0 French, sterile; Catalog Number: PLVW-7.0-38,
Recall # Z-0900-2008;
j) Cook TPN Double Lumen Catheter set; Catheter introducer, includes 6.0 French,
65 CM Silicone Catheter, 7.0 FR. Peel-Away Introducer Set, Wire Guide: .035" DIA.,
30 CM long, Needle: 19UT Gage, 7 cm long, sterile; Catalog Number: C-TPNS-6.0D-
65, Recall # Z-0901-2008;
k) Cook TPN Single Lumen Catheter set; Catheter introducer, includes 6.5 French,
90 CM Silicone Catheter, 7.0 FR. Peel-Away Introducer Set, Wire Guide: .035" DIA.,
30 CM long, Needle: 18 Gage, 7 cm long, sterile; Catalog Number: C-TPNS-6.5-90-
REDO, Recall # Z-0902-2008;
l) Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5
CM long, Wire: .038" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long.
Accepts devices up to 7.0 French, sterile; Catalog Number: C-PLI-7.0-38,
Recall # Z-0903-2008;
m) Catalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product
is not distributed in the U.S. and is sent to foreign affiliates who then apply additional
labeling prior to sale in their countries, Recall # Z-0904-2008
CODE
a) Lot Numbers: F2143720, F2143731, F2144828, F2147203, F2147788 and F2148621;
b) Lot Numbers: F2121224 and F2143768;
c) Lot Number: F2118728;
d) Lot Number: F2114652;
e) Lot Numbers: F2114474 and F2120414;
f) Lot Number: F2143777;
g) Lot Numbers: F2121943, F2123535, F2127628, F2129263, F2130503, F2131307 and
F2136881;
h) Lot Numbers: 1917513, 1923689 and 1927607;
i) Lot Number: F2119096;
j) Lot Numbers: F2114684;
k) Lot Number:1926703;
l) Lot Numbers: 1923714, 1923715, 1923718, 1923719, 1923721, 1923722, 1923723,
1928888, 1928889, 1928891, 1928892, 1928893, 1928894, 1928895, 1928896,
1928897, 1935086, 1935087, 1935089, 1935090, 1935095, 1958841, 1958843,
1958844, 1958847, 1958848, 1958849, 1958850, 1958851 and 1972150;
m) Lot Number: F2121485
RECALLING FIRM/MANUFACTURER
Cook, Inc., Bloomington, IN, by letters on December 7, 2007 and December 18, 2007. Firm initiated recall is complete.
REASON
Packaging Problem: The peel-away sheath does not peel uniformly or completely.
VOLUME OF PRODUCT IN COMMERCE
1,881 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) BD 5 ml Syringe Luer Lok Tip Bulk Sterile Convenience Pak. Latex Free . Sterile.
Reorder Number: 309703, Recall # Z-0914-2008;
b) BD 10 ml Syringe Luer Lok Tip, Reorder #3039605, Recall # Z-0915-2008
CODE
a) Lot numbers: 7123237, 7156175, 7156177, 7212946, 7212948, 7239565, 7239566,
7271878;
b) Lot numbers: 7061015, 7061014, 7092726, 7094789, 7094790, 7123223, 7123225,
7150947, 7150949, 7184442, 7184443, 7184446, 7212935, 7239568, 7239570,
7239569, 7271873
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter on January 7, 2008 and January 11, 2008.
Manufacturer: Becton Dickinson Medical Systems, Canaan, CT. Firm initiated recall is ongoing.
REASON
Defective Seal; The convenience trays may have open seals, which can adversely impact tray sterility.
VOLUME OF PRODUCT IN COMMERCE
4,480,660 total packs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Stryker Round Fluted Bur (6.0mm) Extra-Long for use with TPS Universal Drill
Extra Long "R" Attachment, sterile, REF 5160-10-60, Recall # Z-0988-2008;
b) Stryker Round Fluted Bur (7.6 mm) Extra Long for use with TPS Universal Drill
Extra Long "R" Attachment, sterile, REF 5160-10-75, Recall # Z-0989-2008;
c) Stryker Round Fluted Bur (9.1 mm) Extra Long for use with TPS Universal Drill
Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI;
REF 5160-10-90, Recall # Z-0990-2008;
d) Stryker 4.7 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill
Extra Long "R" Attachment, sterile, REF 5160-20-47, Recall # Z-0991-2008;
e) Stryker 6.0 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill
Extra Long "R" Attachment, sterile, REF 5160-20-60, Recall # Z-0992-2008;
f) Stryker 10.5 x 10.7 mm Fluted Drum, Extra Long, sterile, REF 5160-20-105,
Recall # Z-0993-2008;
g) Stryker 12.3 x 10.7 mm Fluted Drum, Extra Long, sterile, REF 5160-20-123,
Recall # Z-0994-2008;
h) Stryker 7.5 x 7.9 mm Fluted Drum, Extra Long, sterile, REF 5160-20-775,
Recall # Z-0995-2008;
i) Stryker 6.1 x 8.0 mm Acorn Bur, Extra long, sterile, REF 5160-30-60,
Recall # Z-0996-2008;
j) Stryker 7.5 x 9.5 mm Acorn Bur, Extra long, sterile, REF 5160-30-75,
Recall # Z-0997-2008;
k) Stryker 9.1 x 11.4 mm Acorn Bur, Extra Long, REF 5160-30-90, Recall # Z-0998-
2008;
l) Stryker 3.1 mm x 19.1 mm Straight Router, Extra Long, sterile, REF 5160-70-31,
Recall # Z-0999-2008;
m) Stryker Tapered Router Extra Long (2.3mm x 22.0mm) for use with extra long "R"
Attachments, sterile, REF 5160-71-223, Recall # Z-1000-2008;
n) Stryker 2.0 mm x 3.8 mm Neuro Drill, Extra Long, sterile, REF 5160-107-30,
Recall # Z-1001-2008;
o) Stryker 3.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-30,
Recall # Z-1002-2008;
p) Stryker 4.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-40, Recall #
Z-1003-2008;
q) Stryker 5.0mm Round Fluted Bur,Super Long, sterile, REF 5190-10-50, Recall #
Z-1004-2008;
r) Stryker 6.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-60, Recall #
Z-1005-2008;
s) Stryker 7.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-70, Recall #
Z-1006-2008;
t) Stryker 8.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-80, Recall #
Z-1007-2008;
u) Stryker 9.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-90, Recall #
Z-1008-2008;
v) Stryker 10.0 mm Round Fluted Bur, Super Long, sterile, REF 5190-10-100, Recall #
Z-1009-2008;
w) Stryker 4.0mm XX Coarse Round Diamond Bur, Super Long, sterile, REF 5190-13-
140, Recall # Z-1010-2008;
x) Stryker 5.0 mm XX Coarse Round Diamond Bur, Super Long, sterile, REF 5190-13-
150, Recall # Z-1011-2008;
y) Stryker 6mm XX Coarse Round Diamond Bur, Super Long, sterile, REF 5190-13-160,
Recall # Z-1012-2008;
z) Stryker Instruments 7.0mm XX Coarse Round Diamond Bur, Super Long, sterile,
REF 5190-13-170, Recall # Z-1013-2008;
aa) Stryker Instruments 8.omm XX Coarse Round Diamond Bur, Super Long, sterile,
REF 5190-13-180, Recall # Z-1014-2008;
bb) Stryker 6.0 mm Barrel Bur, sterile, REF 5190-17-60, Recall # Z-1015-2008;
cc) Stryker 4.7mm x 7.9mm Fluted Drum, Super Long, sterile, REF 5190-20-47,
Recall # Z-1016-2008;
dd) Stryker 6.0mm x 7.9 mm Bur, Super Long, sterile, REF 5190-20-60, Recall # Z-
1017-2008;
ee) Stryker 10.5mm x 10.7mm Fluted Drum, Super Long, sterile, REF 5190-20-105,
Recall # Z-1018-2008;
ff) Stryker 12.3mm x 10.7mm Fluted Drum, Super Long, sterile, REF 5190-20-123,
Recall # Z-1019-2008;
gg) Stryker 7.8mm x 7.9mm Fluted Drum, Super Long, sterile, REF 5190-20-775,
Recall # Z-1020-2008;
hh) Stryker 9.1mm x 7.9mm Fluted Drum, Super Long, sterile, REF 5190-20-991,
Recall # Z-1021-2008;
ii) Stryker 7.5mm x 7.9mm XX Coarse Diamond Drum, Super Long, sterile, REF 5190-
21-775, Recall # Z-1022-2008;
jj) Stryker 9.1mm x 7.9mm XX Coarse Diamond Drum, Super Long, sterile, REF 5190-
21-991, Recall # Z-1023-2008;
kk) Stryker 6.0mm x 8.0mm Acorn Bur, sterile, REF 5190-30-60, Recall # Z-1024-2008;
ll) Stryker 7.5mm x 9.5mm Acorn Bur, sterile, REF 5190-30-75, Recall # Z-1025-2008;
mm) Stryker 9.0mm x 11.4mm Acorn Bur, sterile, REF 5190-30-90, Recall # Z-1026-
2008;
nn) Stryker 3.1mm x 19.1mm Straight Router, sterile, REF 5190-70-31,
Recall # Z-1027-2008;
oo) Stryker 3.0mm x 34.9mm Straight Router, sterile, REF 5190-70-230, Recall # Z-
1028-2008;
pp) Stryker 32.mm x 18.3mm Heliocoidal Rasp Super Long, for use with "RX"
attachments, sterile, REF 5190-80-30, Recall # Z-1029-2008;
qq) Stryker 3.0mm x 3.8mm Precision Neuro Drill Extended Long for use with Long
"AM" attachments, sterile, REF 5230-107-530S1, Recall # Z-1030-2008;
rr) Stryker 5.0mm Round Fluted Bur, Extra Long, for use with TPS Universal Drill Extra
Long "R" attachment, sterile, REF 5260-10-50, Recall # Z-1031-2008;
ss) Stryker Instruments 6.5mm Round Fluted Bur Extra Long for use with TPS Universal
Drill Extra Long "R" attachment, sterile, REF 5260-10-65, Recall # Z-1032-2008;
tt) Stryker Instruments 7.0mm Round Fluted Bur Extra Long, for use with TPS Universal
Drill Extra Long "R" attachment, sterile, REF 5260-10-70, Recall # Z-1033-2008;
uu) Stryker Instruments Minor modification product, 550-19-20 W/ 304.8mm length,
sterile, product of Ireland, REF 5500019020S3, Recall # Z-1034-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments, Division of Stryker Corporation, Portage, MI, by letter dated January 10, 2008.
Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
10,588
DISTRIBUTION
Nationwide and Internationally
 

END OF ENFORCEMENT REPORT FOR APRIL 23, 2008
 

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