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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 4, 2009
09-05
___________________________________
PRODUCT
5" Whole Grain Sub-Turkey Ham & Oven Roasted Turkey Breast, Product
#02384, Keep Frozen or Refrigerated at all times. Cafe Favorites. Bun, Reduced
Fat American Cheese, Oven Roasted Turkey Breast, Turkey Ham. Recall # F-079-9
CODE
Date code 08343201 thru 08343220
RECALLING FIRM/MANUFACTURER
W. A. Kretch, Inc., Elbow Lake, MN, by telephone and letter on January 2, 2009.
Firm initiated recall is ongoing.
REASON
Sandwiches are contaminated with Listeria monocytogenes based on FDA’s
analysis.
VOLUME OF PRODUCT IN COMMERCE
399 cases (84 subs per case)
DISTRIBUTION
FL, MA, MD, PA, Washington, D.C.
___________________________________
PRODUCT
a) Sunrise Farms brand Alfalfa Sprouts in 4 oz. containers with UPC code 099916120407.
Recall # F-080-9;
b) Sunrise Farms brand Spicy Sprouts in 4 oz. containers with UPC code 099916122401. The product is a mixture of alfalfa, clover, and radish sprouts. Recall # F-081-9;
c) Sunrise Farms brand Crunchy Sprouts in 4 oz. containers with UPC code 099916123415. The product is a mixture of alfalfa, clover, radish and wheat sprouts. Recall # F-082-9;
d) Sunrise Farms brand Onion Mix Sprouts in 4 oz. containers with UPC code
099916060062. The product is a mixture of alfalfa and onion sprouts. Recall
# F-083-9
CODE
Case codes: 0309, 0310, 0311. No code on individual package.
RECALLING FIRM/MANUFACTURER
Sunrise Farms, Inc., Neenah, WI, by press release, telephone, fax and e-mail
beginning December 22, 2008. Firm initiated recall is ongoing.
REASON
Products are contaminated with Salmonella based on the Wisconsin Department
of Agriculture’s analysis.
VOLUME OF PRODUCT IN COMMERCE
2,000 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Fish Cake Sushi, Net Wt. (14 oz). Perishable, Keep Refrigerated. Recall # F-084-9
CODE
DEC 19 2008 and DEC 22 2008
RECALLING FIRM/MANUFACTURER
KRC Food Trading, Inc., Los Angeles, CA, by telephone on December 22,
2008 and by press release on December 23, 2008. Firm initiated recall
is ongoing.
REASON
Product contains undeclared egg.
VOLUME OF PRODUCT IN COMMERCE
900 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Tofu Scrambled in a Pocket Sandwich, 4 oz. frozen product. Recall # F-085-9
CODE
Lot Codes: 10 H148A, 10 H148B, 10 H148C, 10 H148D
RECALLING FIRM/MANUFACTURER
Amy’s Kitchen, Inc., Santa Rosa, CA, by e-mail, telephone and press release
on November 7, 2008. Firm initiated recall is ongoing.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
3,764 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Michel & Charles LeBlanc Fisheries Ltd. 30 lb. Dry Pack ALEWIVES (GASPEREAUX)
Plant Reg. #2466 Product of CANADA. Salted alewives, un-eviscerated and dry
packed in 30 pound white plastic buckets with green lids. Manufacturing code
1938. Recall # F-086-9
CODE
Lot: 1938
RECALLING FIRM/MANUFACTURER
Recalling Firm: Labrador & Son Food Products, Inc., Hialeah
Gardens, FL, by letter on November 17, 2008.
Manufacturing Firm: Michel & Charles Leblanc Fisheries, Cape Pele, Canada.
Firm initiated recall is ongoing.
REASON
30 lb pails of salted Alewives (Gaspereau) contain uneviscerated fish in excess
of 5 inches in length. FDA does not allow this type of uneviscerated fish product
for sale in the U.S.
VOLUME OF PRODUCT IN COMMERCE
70 buckets
DISTRIBUTION
FL
___________________________________
PRODUCT
Dry Packed Alewives “Gaspareau”. Product of Canada, 30 lb. white
plastic pails with green lids. Recall # F-087-9
CODE
Lot: 1788
RECALLING FIRM/MANUFACTURER
Recalling Firm: Quirch Foods Co., Miami, FL, by letter on November 13, 2008
and December 12, 2008.
Manufacturer: Michel & Charles Leblanc Fisheries, Cape Pele, Canada. Firm
initiated recall is ongoing.
REASON
30 lb pails of salted Alewives (Gaspereau) contain uneviscerated fish in excess
of 5 inches in length. FDA does not allow this type of uneviscerated fish product
for sale in the U.S.
VOLUME OF PRODUCT IN COMMERCE
47 pails
DISTRIBUTION
FL
___________________________________
PRODUCT
Dry Packed Alewives “Gaspareau”. Product of Canada, 30 lb. white
plastic buckets with green lids. Recall # F-088-9
CODE
Lot: 1788
RECALLING FIRM/MANUFACTURER
Recalling Firm: Den Mar Exports, Miami, FL, by letter on December 9, 2008.
Manufacturer: Canjam Trading, Inc., Dartmouth, Canada. Firm initiated recall
is ongoing.
REASON
30 lb pails of salted Alewives (Gaspereau) contain uneviscerated fish in excess
of 5 inches in length. FDA does not allow this type of uneviscerated fish product
for sale in the U.S.
VOLUME OF PRODUCT IN COMMERCE
6 pails
DISTRIBUTION
Bahamas and FL
RECALLS
AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Propranolol Hydrochloride Extended Release Capsules, USP, 120 mg, 100 Capsules;
NDC 0228-2780-11; Rx only, Recall # D-173-2009
CODE
Lot: 071A81, Exp. 12/2009
RECALLING FIRM/MANUFACTURER
Actavis Elizabeth LLC, Elizabeth, NJ, by letters on December 15, 2008.
Firm initiated recall is ongoing.
REASON
Potency; failed stability specification for fill weight of capsules (too much
or too little active).
VOLUME OF PRODUCT IN COMMERCE
7,434 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Gabapentin Tablets, 600 mg, 100 Tablets, Rx Only, NDC 0185-0107-01, Catalog
number: 010701. Recall # D-176-2009;
b)Gabapentin Tablets 800 mg, 100 Tablets, Rx Only, NDC 0185-0113-01, Catalog
number 185011301. Recall# D-177-2009
CODE
a) Lot numbers: MK061367, MK061078, MK061079, MK061080, MK061081, MK061368,
MK061082, MK061407, MK061408, MK061409, MK061410, MK061511, MK061512, MK061513,
MK061514, MK061515, MK061642, MK070039, MK070040, MK070041, MK070042, MK070043,
MK071311, MK071530, MK071531, MK071532, MK071633, MK071534, MK071535, MK071536,
MK071537, MK071538, MK072721, MK072722, MK072723, MK072724, MK072725, MK072300,
MK072301, MK072302, MK072303 and MK072304;
b) Lot numbers: MK061424, MK061423, MK061083, MK061084, MK061516, MK061519,
MK061520, MK061518, MK061517 and MK062068
RECALLING FIRM/MANUFACTURER
Sandoz, Inc., Wilson, NC, by letter on August 8, 2008. Firm initiated recall
is ongoing.
REASON
Exceeds Impurity Specification (lactam).
VOLUME OF PRODUCT IN COMMERCE
369,464 units
DISTRIBUTION
AR, CA. CO, GA, IN, MA, MD, NJ, NY and OH
___________________________________
PRODUCT
Triadine" Povidone-Iodine, USP Prep Solution, 10% Topical Solution, Antiseptic/Germicide,
16 Fluid Ounces (473 ml), Cat. No. 10-8216, NDC 50730-8216-6. Recall # D-180-2009
CODE
Lot: 7M27
RECALLING FIRM/MANUFACTURER
H & P Industries, Inc., dba The Triad Group, Hartland, WI, by letter dated
March 27, 2007 and July 28, 2008. Firm initiated recall is ongoing.
REASON
Subpotent
VOLUME OF PRODUCT IN COMMERCE
1,020 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Q-Tussin CF (Dextromethorphan HBr, USP 10mg, Guaifenesin, USP, 100mg, Phenylephrine
HCl, USP, 5mg), 4 FL OZ (118mL), made in USA; NDC 0603-0862-54. Recall Number: D-174-2009
CODE
Lot number: L071G07A
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals, LLC dba Qualitest Pharmaceuticals, Huntsville, AL,
by letter on November 6, 2008. Firm initiated recall is ongoing.
REASON
Subpotent; Phenylephrine HCl at 12 months
VOLUME OF PRODUCT IN COMMERCE
5,807 units
DISTRIBUTION
AL
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
__________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0308-09
CODE
Unit: 72F156227
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc, Gainesville, FL, by facsimile on April
1, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
__________________________
PRODUCT
Red Blood Cells, Apheresis, Leukocytes Reduced, Recall # B-0402-09
CODE
Units: 019GR58154 (split product)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN,
by telephone and fax on August 7, 2007. Firm initiated recall is complete.
REASON
Blood products, collected in an apheresis kit which was not used within the
specified time period after loading, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
a) Recovered Plasma, Recall # B-0403-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0404-09
CODE
a) and b) Units: 9204591
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Lake Charles, LA, by fax on October 1, 2008 and by
electronic mail on December 20, 2007. 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
TX, Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0405-09
CODE
Unit: 72F681998
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on June 9,
2008. Firm initiated recall is complete.
REASON
Blood product, leukoreduced after the post collection time limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Removed, Recall # B-0428-09
CODE
Units: 4727989, 4727982A, 4727982B (split product)
RECALLING FIRM/MANUFACTURER
Northwest Florida Blood Center 1, Pensacola, FL, by letter dated January 5,
2005. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced but which did not meet the requirements
for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0429-09
CODE
Units: 9321667 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on May 18, 2007. Firm
initiated recall is complete.
REASON
Blood products, labeled leukoreduced but which did not meet the requirements
for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0430-09
CODE
Unit: 72F680154
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on May 16,
2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0431-09
CODE
Unit: 72F177002
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on May 6,
2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0440-09;
b) Fresh Frozen Plasma, Recall # B-0441-09
CODE
a) and b) Units: 9079163
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on June 11, 2008 and by follow-up
letter on June 25, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets, Recall # B-0442-09
CODE
Unit: 4308104
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by fax on June 4, 2008 and by follow-up letter
on June 23, 2008. 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
TX
___________________________________
PRODUCT
Platelets, Recall # B-0446-09
CODE
Unit: 4265438
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on June 10, 2008 and by follow-up
letter on June 24, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malaria endemic
area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0447-09
CODE
Unit: 9066803
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on April 15, 2008 and by letter
on April 21, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malaria endemic
area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0448-09;
b) Platelets, Recall # B-0449-09
CODE
a) and b) Unit: 7988371
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on November 7, 2007 and by letter
on November 30, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malaria
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0451-09
CODE
Unit: 72E03934X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by telephone on October
21, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0452-09
CODE
Units: W051708200353 Part 1; W051708200353 Part 2; W051708200533 Part 1; W051708200533
Part 2; W051708200533 Part 3; W051708200704
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by facsimile on July 11, 2008. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor taking the medication Finasteride, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
RI, PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0455-09
CODE
Unit: 9067929
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on February 19, 2008. 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
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0456-09
CODE
Unit: FQ96443
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on November 8,
2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic
for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0457-09;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0458-09
CODE
a) Unit: LC86197;
b) Unit: LC90092
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on October 16,
2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic
for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ, WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0459-09
CODE
Unit: 4286315
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on August 6, 2008. Firm initiated
recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated
as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0460-09
CODE
Unit: 7978363
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on September 20, 2007 and by letter
on October 12, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Source Plasma, Recall # B-0179-09
CODE
Units: 174021950; 174057571
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Fort Worth, TX, by fax on October 11, 2007.
Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-0436-09
CODE
Unit: KZ036300
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by e-mail on May 8, 2008. 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
Austria
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0437-09;
b) Fresh Frozen Plasma, Recall # B-0438-09
CODE
a) and b) Units: W036908608173
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by telephone on August 20, 2008 and
by letters dated September 17, and November 17, 2008. Firm initiated recall
is complete.
REASON
Blood products, collected from a donor whose temperature was not determined,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD, DE
___________________________________
PRODUCT
Source Plasma, Recall # B-0443-09
CODE
Unit: 174056893
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Fort Worth, TX, by fax on March 12, 2007.
Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0450-09
CODE
Unit: 2139137
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by telephone on February 12, 2008.
Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with gram positive Actinomycetes,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0453-09
CODE
Unit: 6641593
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on May 2, 2008 and September 17, 2008.
Firm initiated recall is complete.
REASON
Blood product, which may have been exposed to unacceptable temperatures during
storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0454-09
CODE
Units: 6226592; 6226593; 6226594; 1625143
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on July 10, 2008.
Firm initiated recall is complete.
REASON
Blood products, which were labeled with an incorrect expiration date, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
a) Medtronic SynchroMed EL Programmable Pump, Model 8626-10. 10 mL Reservoir.
The contents [STERILE] of the inner package have been sterilized by ethylene
oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part
of the SynchroMed EL Infusion System designed to contain and administer parenteral
drugs to a specific site. The implantable components of the SynchroMed EL Infusion
System include the pump with or without a side catheter access port, catheters,
and catheter accessories. The SynchroMed EL lnfusion System is indicated for
use when patient therapy requires the chronic infusion of drugs or fluids.
The EL Infusion System with a 10 reservoir volume is indicated for use in the
smaller patient who has insufficient body mass to support the larger SynchroMed
EL pump or in patients who choose a smaller, lower profile pump when presented
with the choice, when patient therapy requires the chronic infusion of drugs
or fluids. Recall # Z-0583-2009;
b) Medtronic SynchroMed EL Programmable Pump, Model 8626L-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0584-2009;
c) Medtronic SynchroMed EL Programmable Pump, Model 8626-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0585-2009;
d) Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0586-2009;
e) Medtronic SynchroMed EL Programmable Pump, Model 8627-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0587-2009;
f) Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0588-2009;
g) Medtronic SynchroMed EL Programmable Pump, Model 8627-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0589-2009;
h) Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0590-2009;
i) Medtronic SynchroMed II Programmable Pump, Model 8637-20. 20 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed II programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the follosing drugs or fluids: -chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free morphine sulfate sterile solution. - chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of serve chronic pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. -chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen Injection). -Chronic intravascular infusion of floxuridine, (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency. Recall # Z-0591-2009;
j) Medtronic SynchroMed II Programmable Pump, Model 8637-40. 40 mL Reservoir.
The contents [STERILE] of the inner package have been sterilized by ethylene
oxide gas. The implantable Medtronic SynchroMed II programmable Pump is part
of the SynchroMed II Infusion System designed to contain and administer prescribed
drugs to a specific site. The implantable components of the SynchroMed II Infusion
System include the pump, catheter, and catheter accessories. The SynchroMed
II Programmable Pump is indicated when patient therapy requires the chronic
infusion of the follosing drugs or fluids: -chronic intraspinal (epidural and
intrathecal) infusion of preservative-free morphine sulfate sterile solution
in the treatment of chronic intractable pain. Preservative-free sterile saline,
USP, can be used to achieve the physician-prescribed concentration of preservative-free
morphine sulfate sterile solution. - Chronic intrathecal infusion of preservative-free
ziconotide sterile solution for the management of serve chronic pain. Preservative-free
sterile saline, USP, can be used to achieve the physician-prescribed concentration
of preservative-free ziconotide sterile solution after the initial fill of
the pump with this drug. – Chronic intrathecal infusion of Lioresal Intrathecal
(baclofen injection) in the management of severe spasticity. Preservative-free
sterile saline, USP, can be used to achieve the physician-prescribed concentration
of Lioresal Intrathecal (baclofen Injection). - Chronic intravascular infusion
of floxuridine, (FUDR) or methotrexate for the treatment of primary or metastatic
cancer. Bacteriostatic water or preservative-free sterile saline, USP, can
be used to achieve the physician-prescribed concentration of chemotherapy drugs
or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated)
may be used during an interruption in chemotherapy to maintain pump and catheter
patency. Recall # Z-0592-2009
CODE
All SynchroMed EL and SynchroMed II pumps
RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN, by letter beginning August 25, 2008.
Firm initiated recall is ongoing.
REASON
Medtronic issued a letter to healthcare professionals providing important safety
information regarding MRI (magnetic resonance imaging) effects on SynchroMed
EL and SynchroMed II implantable infusion pumps. As stated in product labeling,
the magnetic field of an MRI will temporarily stop the rotor of the pump motor
and suspend drug infusion for the duration of MRI exposure for all SynchroMed
pumps. The pump should resume normal operation when removed from the MRI magnetic
field, however new information has been identified related to the following MRI
effects: 1) There is the potential for a delay in the return of proper drug infusion
after an MRI (this affects all SynchroMed pumps) and 2) There is the potential
for a delay in the logging of motor stall events after an MRI (this only affects
SynchroMed II pumps).
VOLUME OF PRODUCT IN COMMERCE
Approx 76,253
DISTRIBUTION
Nationwide and countries of Algeria, Aruba, Austria, Belarus, Belgium, Croatia,
Cyprus Czech Republic, Denmark, Egypt, Finland, France, French Polynesia, Germany,
Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy , Jordan
Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway,
Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino,
Saudi Arabia, Serbia and Montenegro, Slovakia, Slovenia, Sough Africa, Spain,
Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican
City State, New Caledonia, Brazil, Dominican Republic, Mexico, Hong Kong, Singapore,
Canada, Australia and Japan
___________________________________
PRODUCT
Liko AB Uno Lifts, Powered (non-AC) Patient Lift: a) Uno 100 EM/EE; b) Uno 101.
Uno 100 and 102 are battery powered mobile lifts, designed to be used in most
of the common lifting situations, for example transfers between bed and wheelchair,
to and from the toilet and bathtub or for lifting to and from the floor. Recall
# Z-0605-2009
CODE
a) Serial numbers: 7090001 through 7096200;
b) Serial numbers: 10001 through 1000. Production Dates: Manufactured prior to
June 26, 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Liko North America Inc., Franklin, MA,
by letter dated December 5, 2008.
Manufacturer: Liko AB, Lulea, Sweden. Firm initiated the recall
is ongoing.
REASON
Actuator of the lift has potential to separate when the upper arm is fully extended.
VOLUME OF PRODUCT IN COMMERCE
24,070 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product
is intended for draining the pericardial sac or the cardiac chambers. Recall
# Z-0609-2009
CODE
Lot number: 2006100305
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Cardiovascular Revascularization & Surgical Therap,
Brooklyn Park, MN, by letter dated October 1, 2008.
Manufacturer: Atek Medical Manufacturing, Grand Rapids, MI. Firm initiated
recall is ongoing.
REASON
Separates: Six complaints were received from two locations. In all cases the
sump tip assembly separated from the tubing during device removal and had to
be retrieved from the patient. There were no adverse events affecting these patients.
VOLUME OF PRODUCT IN COMMERCE
560 units
DISTRIBUTION
NC, PA, IA, WI, IN, VA, IL, KY, and TX, and countries of Australia, France, Hong
Kong, Netherlands, and Poland.
___________________________________
PRODUCT
a) CAD SCIENCES LLC 3 TP TheraMapTM Software, for oncology treatment planning,
assessment and monitoring of the patient response. Recall # Z-0653-2009;
b) CAD SCIENCES LLC 3 TP PrecisionPointTM Software, for biopsy guidance. Recall
# Z-0654-2009;
CODE
All software versions
RECALLING FIRM/MANUFACTURER
iCAD, Inc., Nashua, NH, by telephone and letter on December 5, 2008.
Firm initiated recall is ongoing.
REASON
Software modules not approved for this indication.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook Probe.
Product Code EPS01. Recall # Z-0655-2009;
b) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe. Product Code EPS02. Recall # Z-0656-2009;
c) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Right Angle Probe. Product Code EPS03. Recall # Z-0657-2009;
d) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Curved Dissector Probe. Product Code EPS04. Recall # Z-0658-2009;
e) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe. Product Code EPS05. Recall # Z-0659-2009;
f) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Spatula Probe. Product Code EPS06. Recall # Z-0660-2009;
g) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Right Angle Probe. Product Code EPS07. Recall # Z-0661-2009;
h) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Curved Dissector Probe. Product Code EPS08. Recall # Z-0662-2009;
i) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Needle
Probe. Product Code EPS09. Recall # Z-0663-2009;
CODE
a) Lot # E4K594, Exp Date 2012-12; Lot # E4K67R, Exp Date 2012-12; Lot # E4K93J,
Exp Date 2012-12; Lot # E4KC5J, Exp Date 2013-01; Lot # E4KF21, Exp Date 2013-01;
Lot # E4KK1M, Exp Date 2013-02; Lot # E4KK7Z, Exp Date 2013-02; Lot # E4KL9T,
Exp Date 2013-02; Lot # E4KM4A, Exp Date 2013-02; Lot # E4KP38, Exp Date 2013-02;
Lot # E4KT81, Exp Date 2013-03; Lot # E4KU2X, Exp Date 2013-03; Lot # E4KX2D,
Exp Date 2013-03; Lot # E4L01C, Exp Date 2013-04; Lot # E4L02M, Exp Date 2013-04;
Lot # E4L21T, Exp Date 2013-04; Lot # E4L66N, Exp Date 2013-04; Lot # E4L738,
Exp Date 2013-05; Lot # E4L82C, Exp Date 2013-05; Lot # E4LA6P, Exp Date 2013-05;
Lot # E4LC88, Exp Date 2013-05; Lot # E4LE62, Exp Date 2013-05; Lot # E4LG4C,
Exp Date 2013-06; Lot # E4LJ8W, Exp Date 2013-06; Lot # E4LK99, Exp Date 2013-06;
Lot # E4LM57, Exp Date 2013-06; Lot # E4LP5G, Exp Date 2013-07; Lot # E4LU30,
Exp Date 2013-07; Lot # E4LV48, Exp Date 2013-07; Lot # E4LX91, Exp Date 2013-07;
Lot # E4M068, Exp Date 2013-08; Lot # E4M12K, Exp Date 2013-08; Lot # E4M23T,
Exp Date 2013-08; Lot # E4M33W, Exp Date 2013-08; Lot # E4M387, Exp Date 2013-08;
Lot # E4M43R, Exp Date 2013-08; Lot # E4M54H, Exp Date 2013-08; Lot # E4M75K,
Exp Date 2013-09; Lot # E4M973, Exp Date 2013-09; and Lot # E4MA8R, Exp Date
2013-09;
b) Lot # E4K181, Exp. Date 2012-12; Lot # E4K58C, Exp. Date 2012-12; Lot # E4KC5X, Exp. Date 2013-01; Lot # E4KD1P, Exp. Date 2013-01; Lot # E4KF2N, Exp. Date 2013-01; Lot # E4KG70, Exp. Date 2013-01; Lot # E4KK22, Exp. Date 2013-02; Lot # E4KP2F, Exp. Date 2013-02; Lot # E4KV17, Exp. Date 2013-03; Lot # E4KY1A, Exp. Date 2013-03; Lot # E4KY70, Exp. Date 2013-03; Lot # E4L03H, Exp. Date 2013-04; Lot # E4L519, Exp. Date 2013-04; Lot # E4L73Z, Exp. Date 2013-05; Lot # E4L916, Exp. Date 2013-05; Lot # E4LC3K, Exp. Date 2013-05; Lot # E4LD8L, Exp. Date 2013-05; Lot # E4LF60, Exp. Date 2013-05; Lot # E4LG4D, Exp. Date 2013-06; Lot # E4LL7P, Exp. Date 2013-06; Lot # E4LT6E, Exp. Date 2013-07; Lot # E4LX4H, Exp. Date 2013-07; Lot # E4M045, Exp. Date 2013-08; Lot # E4M12L, Exp. Date 2013-08; Lot # E4M27N, Exp. Date 2013-08; Lot # E4M466, Exp. Date 2013-08; Lot # E4M535, Exp. Date 2013-08; Lot # E4M54F, Exp. Date 2013-08; Lot # E4M69H, Exp. Date 2013-09; Lot # E4M838, Exp. Date 2013-09; Lot # E4MA4M, Exp. Date 2013-09; and Lot # E4MC3A, Exp. Date 2013-09;
c) Lot # E4K182, Exp. Date 2012-12; Lot # E4K59R, Exp. Date 2012-12; Lot # E4K67T, Exp. Date 2012-12; Lot # E4K81D, Exp. Date 2012-12; Lot # E4K938, Exp. Date 2012-12; Lot # D4JL20, Exp. Date 2012-09; Lot # D4JL21, Exp. Date 2012-09; Lot # D4JL22, Exp. Date 2012-09; Lot # E4KC1M, Exp. Date 2013-01; Lot # E4KF20, Exp. Date 2013-01; Lot # E4KK23, Exp. Date 2013-02; Lot # E4KK6V, Exp. Date 2013-02; Lot # E4KL0N, Exp. Date 2013-02; Lot # E4KR6Y, Exp. Date 2013-03; Lot # E4KV1X, Exp. Date 2013-03; Lot # E4KX2Z, Exp. Date 2013-03; Lot # E4KY5H, Exp. Date 2013-03; Lot # E4L18A, Exp. Date 2013-04; Lot # E4L404, Exp. Date 2013-04; Lot # E4L66M, Exp. Date 2013-04; Lot # E4L69A, Exp. Date 2013-05; Lot # E4L871, Exp. Date 2013-05; Lot # E4LA7Z, Exp. Date 2013-05; Lot # E4LD0T, Exp. Date 2013-05; Lot # E4LF5F, Exp. Date 2013-05; Lot # E4LJ46, Exp. Date 2013-06; Lot # E4LJ4F, Exp. Date 2013-06; Lot # E4LK9C, Exp. Date 2013-06; Lot # E4LN16, Exp. Date 2013-06; Lot # E4LP57, Exp. Date 2013-07; Lot # E4LR66, Exp. Date 2013-07; Lot # E4LT3Y, Exp. Date 2013-07; Lot # E4LU2Z, Exp. Date 2013-07; Lot # E4LV56, Exp. Date 2013-07; Lot # E4M00W, Exp. Date 2013-08; Lot # E4M01X, Exp. Date 2013-08; Lot # E4M120, Exp. Date 2013-08; Lot # E4M20L, Exp. Date 2013-08; Lot # E4M23R, Exp. Date 2013-08; Lot # E4M31A, Exp. Date 2013-08; Lot # E4M376, Exp. Date 2013-08; Lot # E4M39C, Exp. Date 2013-08; Lot # E4M572, Exp. Date 2013-08; Lot # E4M57U, Exp. Date 2013-08; Lot # E4M62M, Exp. Date 2013-08; Lot # E4M914, Exp. Date 2013-09; Lot # E4MA2R, Exp. Date 2013-09; and Lot # E4MD45, Exp. Date 2013-09;
d) Lot # E4KC2J, Exp. Date 2013-01; Lot # E4KG8M, Exp. Date 2013-01; Lot # E4KP8H, Exp. Date 2013-02; Lot # E4KV0T, Exp. Date 2013-03; Lot # E4L030, Exp. Date 2013-04; Lot # E4L892, Exp. Date 2013-05; Lot # E4LD0R, Exp. Date 2013-05; Lot # E4LK7V, Exp. Date 2013-06; Lot # E4LX1D, Exp. Date 2013-07; Lot # E4M072, Exp. Date 2013-08; Lot # E4M28F, Exp. Date 2013-08; Lot # E4M91D, Exp. Date 2013-09; and Lot # E4MA2P, Exp. Date 2013-09;
e) Lot # E4K72Z, Exp. Date 2012-12; Lot # E4K92E, Exp. Date 2012-12; Lot # E4KE29, Exp. Date 2013-01; Lot # E4KH2L, Exp. Date 2013-01; Lot # E4KP2E, Exp. Date 2013-02; Lot # E4KU5K, Exp. Date 2013-03; Lot # E4KX1Y, Exp. Date 2013-03; Lot # E4L03G, Exp. Date 2013-04; Lot # E4L69Y, Exp. Date 2013-05; Lot # E4LA5X, Exp. Date 2013-05; Lot # E4LE64, Exp. Date 2013-05; Lot # E4LF6H, Exp. Date 2013-05; Lot # E4LN1K, Exp. Date 2013-06; Lot # E4LR3W, Exp. Date 2013-07; Lot # E4LU50, Exp. Date 2013-07; Lot # E4M00X, Exp. Date 2013-08; Lot # E4M24N, Exp. Date 2013-08; Lot # E4M506, Exp. Date 2013-08; Lot # E4M62L, Exp. Date 2013-08; Lot # E4M79W, Exp. Date 2013-09; and Lot # E4MA4P, Exp. Date 2013-09;
f) Lot # E4K730, Exp. Date 2012-12; Lot # E4K937, Exp. Date 2012-12; Lot # E4KE28, Exp. Date 2013-01; Lot # E4KF4E, Exp. Date 2013-01; Lot # E4KK3D, Exp. Date 2013-02; Lot # E4KK9Z, Exp. Date 2013-02; Lot # E4KT18, Exp. Date 2013-03; Lot # E4KU5A, Exp. Date 2013-03; Lot # E4KW7W, Exp. Date 2013-03; Lot # E4KY71, Exp. Date 2013-03; Lot # E4KZ5L, Exp. Date 2013-03; Lot # E4KZ9G, Exp. Date 2013-04; Lot # E4L189, Exp. Date 2013-04; Lot # E4L41U, Exp. Date 2013-04; Lot # E4L53G, Exp. Date 2013-04; Lot # E4L54M, Exp. Date 2013-04; Lot # E4L891, Exp. Date 2013-05; Lot # E4LA6F, Exp. Date 2013-05; Lot # E4LD1N, Exp. Date 2013-05; Lot # E4LF86, Exp. Date 2013-05; Lot # E4LJ4C, Exp. Date 2013-06; Lot # E4LN1J, Exp. Date 2013-06; Lot # E4LT6C, Exp. Date 2013-07; Lot # E4LU3P, Exp. Date 2013-07; Lot # E4M20H, Exp. Date 2013-08; Lot # E4M338, Exp. Date 2013-08; Lot # E4M457, Exp. Date 2013-08; Lot # E4M54G, Exp. Date 2013-08; Lot # E4M634, Exp. Date 2013-08; and Lot # E4MA4N, Exp. Date 2013-09;
g) Lot # E4KC1V, Exp Date 2013-01; Lot # E4KJ1J, Exp Date 2013-02; Lot # E4KM09, Exp Date 2013-02; Lot # E4KV1N, Exp Date 2013-03; Lot # E4KZ5M, Exp Date 2013-03; Lot # E4L464, Exp Date 2013-04; Lot # E4L664, Exp Date 2013-04; Lot # E4LA0W, Exp Date 2013-05; Lot # E4LC3M, Exp Date 2013-05; Lot # E4LE63, Exp Date 2013-05; Lot # E4LJ89, Exp Date 2013-06; Lot # E4LK9K, Exp Date 2013-06; Lot # E4LR3Y, Exp Date 2013-07; Lot # E4LX68, Exp Date 2013-07; Lot # E4LX88, Exp Date 2013-07; Lot # E4M071, Exp Date 2013-08; Lot # E4M43P, Exp Date 2013-08; Lot # E4M83K, Exp Date 2013-09; and Lot # E4M98Y, Exp Date 2013-09;
h) Lot # E4KF22, Exp. Date 2013-01; Lot # E4L088, Exp. Date 2013-04; Lot # E4LR3X, Exp. Date 2013-07; and Lot # E4MD46, Exp. Date 2013-09;
i) Lot # E4KC2H, Exp. Date 2013-01; Lot # E4KJ1H, Exp. Date 2013-02; Lot #
E4KR73, Exp. Date 2013-03; Lot # E4KW8R, Exp. Date 2013-03; Lot # E4L465, Exp.
Date 2013-04; Lot # E4LA5T, Exp. Date 2013-05; Lot # E4LD9H, Exp. Date 2013-05;
Lot # E4LF6M, Exp. Date 2013-05; Lot # E4LK7U, Exp. Date 2013-06; Lot # E4LU3N,
Exp. Date 2013-07; Lot # E4M33D, Exp. Date 2013-08; Lot # E4M69J, Exp. Date
2013-09; and Lot # E4M83N, Exp. Date 2013-09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letters on December
9, 2008.
Manufacturer: Ethicon Endo-Surgery, Inc. S.A. de C.V. Planta II, Ciudad
Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
Nickel exposure: The stainless steel tips on the affected product were degrading,
causing a small amount of nickel to be released, which may lead to health risks
in some patients, particularly those with a known or suspected nickel allergy
or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel
in the affected product could elicit a reaction in those patients with nickel
sensitivity or could sensitize certain patients to nickel exposure in the future.
VOLUME OF PRODUCT IN COMMERCE
109,374 instruments
DISTRIBUTION
Nationwide and countries of Argentina, Australia, Austria, Belgium, Brazil,
Canada, China, Colombia, Dominican Republic, Egypt, England, Equator, Germany,
Greece, India, Indonesia, Israel, Italy, Japan, Korea, Malaysia, Mexico, Pakistan,
Panama, Poland, Republic OF Yemen, Russia, Singapore, South Africa, Spain,
Switzerland, Taiwan, Thailand, Trinidad Turkey United Arab Emirates, Uruguay,
and Venezuela
___________________________________
PRODUCT
Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part
number: SC1439-1000. Recall # Z-0664-2009
CODE
Lot number: 17877-071707 exp. 7/2017
RECALLING FIRM/MANUFACTURER
Stelkast Co., McMurray, PA, by telephone on October 7, 2008. Firm initiated
recall is complete.
REASON
Sterility may be compromised due to breach in packaging.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
TX, WV
___________________________________
PRODUCT
a) Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation.
Recall # Z-0665-2009;
b) Medtronic Maximo II VR D284VRC, for ventricular pacing and defibrillation. Recall # Z-0666-2009;
c) Maximo II CRT D284TRK, for ventricular pacing and defibrillation. Recall
# Z-0667-2009;
CODE
a) Lot Serial Number: PZM600131S PZM600054S PZM600616S PZM600617S PZM600620S
PZM600615S PZM600523S PZM600111S PZM600213S PZM600502S PZM600595S PZM600600S
PZM600277S PZM600078S PZM600581S PZM600582S PZM600597S PZM600602S PZM600530S
PZM600108S PZM600495S PZM600497S PZM600498S PZM600500S PZM600501S PZM600151S
PZM600152S PZM600153S PZM600446S PZM600447S PZM600448S PZM600264S PZM600278S
PZM600469S PZM600094S PZM600401S PZM600052S PZM600053S PZM600517S PZM600621S
PZM600622S PZM600233S PZM600539S PZM600129S PZM600130S PZM600132S PZM600160S
PZM600162S PZM600207S PZM600208S PZM600138S PZM600140S PZM600145S PZM600146S
PZM600148S PZM600156S PZM600198S PZM600056S PZM600092S PZM600104S PZM600105S
PZM600147S PZM600168S PZM600252S PZM600051S PZM600199S PZM600057S PZM600273S
PZM600075S PZM600232S PZM600472S PZM600049S PZM600203S PZM600276S PZM600071S
PZM600143S PZM600098S PZM600110S PZM600167S PZM600101S PZM600109S PZM600126S
PZM600150S PZM600491S PZM600492S PZM600080S PZM600081S PZM600281S PZM600282S
PZM600283S PZM600284S PZM600285S PZM600286S PZM600287S PZM600288S PZM600289S
PZM600290S PZM600184S PZM600192S PZM600245S PZM600180S PZM600262S PZM600526S
PZM600643S PZM600473S PZM600186S PZM600189S PZM600243S PZM600266S PZM600247S
PZM600254S PZM600556S PZM600557S PZM600558S PZM600559S PZM600560S PZM600561S
PZM600562S PZM600563S PZM600584S PZM600586S PZM600112S PZM600544S PZM600599S
PZM600486S PZM600405S PZM600406S PZM600407S PZM600408S PZM600409S PZM600410S
PZM600411S PZM600412S PZM600413S PZM600414S PZM600415S PZM600416S PZM600417S
PZM600418S PZM600419S PZM600420S PZM600421S PZM600422S PZM600423S PZM600424S
PZM600425S PZM600426S PZM600427S PZM600428S PZM600429S PZM600430S PZM600431S
PZM600432S PZM600433S PZM600434S PZM600435S PZM600436S PZM600437S PZM600438S
PZM600439S PZM600440S PZM600441S PZM600442S PZM600443S PZM600444S PZM600445S
PZM600059S PZM600060S PZM600061S PZM600062S PZM600063S PZM600064S PZM600065S
PZM600066S PZM600135S PZM600136S PZM600137S PZM600116S PZM600117S PZM600118S
PZM600119S PZM600120S PZM600121S PZM600122S PZM600123S PZM600124S PZM600125S
PZM600079S PZM600206S PZM600578S PZM600215S PZM600216S PZM600217S PZM600218S
PZM600219S PZM600220S PZM600221S PZM600222S PZM600223S PZM600224S PZM600265S
PZM600083S PZM600470S PZM600528S PZM600533S PZM600640S PZM600577S PZM600076S
PZM600594S PZM600241S PZM600242S PZM600272S PZM600274S PZM600573S PZM600574S
PZM600576S PZM600161S PZM600163S PZM600234S PZM600133S PZM600134S PZM600193S
PZM600194S PZM600090S PZM600509S PZM600072S PZM600142S PZM600173S PZM600623S
PZM600624S PZM600482S PZM600196S PZM600197S PZM600535S PZM600536S PZM600067S
PZM600068S PZM600077S PZM600490S PZM600190S PZM600611S PZM600612S PZM600084S
PZM600087S PZM600088S PZM600089S PZM600231S PZM600201S PZM600202S PZM600141S
PZM600471S PZM600546S PZM600235S PZM600236S PZM600048S PZM600128S PZM600550S
PZM600551S PZM600073S PZM600085S PZM600055S PZM600158S PZM600251S PZM600165S
PZM600280S PZM600070S PZM600170S PZM600204S PZM600097S PZM600545S PZM600058S
PZM600166S PZM600587S PZM600512S PZM600513S PZM600291S PZM600292S PZM600293S
PZM600107S PZM600510S PZM600050S PZM600149S PZM600102S PZM600238S PZM600240S
PZM600598S PZM600601S PZM600086S PZM600091S PZM600596S PZM600099S PZM600100S
PZM600093S PZM600155S PZM600157S PZM600159S PZM600253S PZM600171S PZM600590S
PZM600493S PZM600074S PZM600209S PZM600580S PZM600494S PZM600069S PZM600200S
PZM600144S PZM600154S PZM600047S PZM600095S PZM600275S PZM600547S PZM600225S
PZM600113S PZM600613S PZM600614S PZM600542S PZM600237S PZM600402S PZM600403S
PZM600404S PZM600514S PZM600515S PZM600258S PZM600259S PZM600487S PZM600248S
PZM600279S PZM600508S PZM600256S PZM600257S PZM600608S PZM600609S PZM600488S
PZM600489S PZM600261S PZM600263S PZM600641S PZM600642S PZM600270S PZM600516S
PZM600589S PZM600592S PZM600255S PZM600249S PZM600169S PZM600172S PZM600174S
PZM600175S PZM600176S PZM600177S PZM600178S PZM600179S PZM600181S PZM600182S
PZM600183S PZM600187S PZM600191S PZM600246S PZM600474S PZM600644S PZM600507S
PZM600543S PZM600250S PZM600244S PZM600534S PZM600548S PZM600549S PZM600537S
PZM600538S PZM600552S PZM600553S PZM600185S PZM600188S PZM600521S PZM600522S
PZM600271S PZM600527S PZM600607S PZM600627S PZM600555S PZM600646S PZM600294S
PZM600295S PZM600511S PZM600713S PZM600714S PZM600260S PZM600524S PZM600525S
PZM600554S PZM600268S PZM600269S PZM600475S PZM600476S PZM600477S PZM600214S
PZM600541S PZM600210S PZM600212S PZM600520S PZM600540S PZM600114S PZM600115S
PZM600226S PZM600229S PZM600230S PZM600483S PZM600484S PZM600485S PZM600529S
PZM600205S PZM600572S PZM600575S PZM600267S PZM600106S PZM600164S PZM600103S
and PZM600645S;
b) Lot Serial No PZN600430S PZN600431S PZN600436S PZN600428S PZN600422S PZN600385S PZN600317S PZN600383S PZN600308S PZN600418S PZN600388S PZN600409S PZN600410S PZN600250S PZN600391S PZN600392S PZN600374S PZN600375S PZN600116S PZN600333S PZN600334S PZN600335S PZN600336S PZN600337S PZN600145S PZN600146S PZN600147S PZN600148S PZN600348S PZN600349S PZN600057S PZN600058S PZN600351S PZN600352S PZN600247S PZN600248S PZN600328S PZN600462S PZN600419S PZN600199S PZN600200S PZN600129S PZN600130S PZN600131S PZN600132S PZN600134S PZN600151S PZN600152S PZN600153S PZN600154S PZN600167S PZN600181S PZN600182S PZN600201S PZN600208S PZN600209S PZN600210S PZN600211S PZN600212S PZN600213S PZN600214S PZN600249S PZN600325S PZN600326S PZN600327S PZN600329S PZN600330S PZN600362S PZN600381S PZN600463S PZN600464S PZN600082S PZN600083S PZN600084S PZN600085S PZN600086S PZN600071S PZN600088S PZN600149S PZN600138S PZN600079S PZN600429S PZN600442S PZN600101S PZN600135S PZN600140S PZN600183S PZN600111S PZN600067S PZN600361S PZN600074S PZN600055S PZN600107S PZN600143S PZN600170S PZN600171S PZN600266S PZN600169S PZN600341S PZN600254S PZN600255S PZN600256S PZN600257S PZN600258S PZN600259S PZN600260S PZN600261S PZN600262S PZN600263S PZN600197S PZN600237S PZN600239S PZN600219S PZN600246S PZN600236S PZN600203S PZN600227S PZN600252S PZN600164S PZN600202S PZN600396S PZN600397S PZN600398S PZN600399S PZN600400S PZN600401S PZN600402S PZN600403S PZN600404S PZN600405S PZN600425S PZN600426S PZN600427S PZN600196S PZN600318S PZN600195S PZN600354S PZN600316S PZN600127S PZN600123S PZN600313S PZN600312S PZN600268S PZN600269S PZN600270S PZN600271S PZN600272S PZN600273S PZN600274S PZN600275S PZN600276S PZN600277S PZN600278S PZN600060S PZN600061S PZN600062S PZN600063S PZN600064S PZN600574S PZN600136S PZN600137S PZN600359S PZN600547S PZN600251S PZN600370S PZN600372S PZN600114S PZN600117S PZN600184S PZN600185S PZN600186S PZN600187S PZN600188S PZN600189S PZN600190S PZN600191S PZN600307S PZN600103S PZN600379S PZN600380S PZN600087S PZN600407S PZN600408S PZN600180S PZN600363S PZN600364S PZN600365S PZN600366S PZN600414S PZN600415S PZN600465S PZN600466S PZN600467S PZN600133S PZN600166S PZN600100S PZN600075S PZN600340S PZN600115S PZN600434S PZN600435S PZN600320S PZN600168S PZN600068S PZN600069S PZN600324S PZN600078S PZN600423S PZN600094S PZN600420S PZN600097S PZN600098S PZN600099S PZN600122S PZN600090S PZN600091S PZN600175S PZN600176S PZN600141S PZN600303S PZN600304S PZN600389S PZN600206S PZN600207S PZN600049S PZN600050S PZN600053S PZN600054S PZN600128S PZN600424S PZN600073S PZN600095S PZN600076S PZN600077S PZN600059S PZN600080S PZN600139S PZN600155S PZN600302S PZN600350S PZN600105S PZN600106S PZN600215S PZN600216S PZN600546S PZN600144S PZN600118S PZN600119S PZN600120S PZN600052S PZN600437S PZN600438S PZN600439S PZN600112S PZN600113S PZN600440S PZN600441S PZN600096S PZN600241S PZN600109S PZN600110S PZN600102S PZN600065S PZN600072S PZN600331S PZN600066S PZN600081S PZN600413S PZN600421S PZN600332S PZN600070S PZN600172S PZN600173S PZN600142S PZN600433S PZN600048S PZN600108S PZN600104S PZN600056S PZN600125S PZN600386S PZN600051S PZN600265S PZN600217S PZN600267S PZN600345S PZN600346S PZN600231S PZN600232S PZN600321S PZN600223S PZN600339S PZN600229S PZN600230S PZN600305S PZN600306S PZN600322S PZN600323S PZN600235S PZN600369S PZN600245S PZN600347S PZN600406S PZN600228S PZN600432S PZN600156S PZN600157S PZN600158S PZN600159S PZN600161S PZN600163S PZN600165S PZN600218S PZN600220S PZN600221S PZN600222S PZN600198S PZN600360S PZN600238S PZN600338S PZN600240S PZN600224S PZN600226S PZN600367S PZN600390S PZN600377S PZN600378S PZN600393S PZN600394S PZN600160S PZN600162S PZN600355S PZN600356S PZN600357S PZN600358S PZN600204S PZN600205S PZN600371S PZN600395S PZN600469S PZN600387S PZN600264S PZN600342S PZN600628S PZN600629S PZN600233S PZN600368S PZN600243S PZN600244S PZN600353S PZN600382S PZN600314S PZN600315S PZN600319S PZN600384S PZN600416S PZN600192S PZN600193S PZN600311S PZN600417S PZN600443S PZN600194S PZN600309S PZN600310S PZN600124S PZN600126S PZN600289S PZN600344S PZN600343S PZN600373S PZN600178S PZN600179S PZN600242S PZN600376S PZN600089S and PZN600449S;
c) Lot Serial No PZP600096S PZP600610S PZP600608S PZP600546S PZP600149S PZP600569S
PZP600587S PZP600589S PZP600612S PZP600450S PZP600557S PZP600193S PZP600558S
PZP600559S PZP600531S PZP600533S PZP600534S PZP600535S PZP600536S PZP600199S
PZP600215S PZP600473S PZP600474S PZP600475S PZP600476S PZP600477S PZP600478S
PZP600479S PZP600480S PZP600607S PZP600513S PZP600514S PZP600515S PZP600516S
PZP600530S PZP600092S PZP600093S PZP600562S PZP600571S PZP600609S PZP600596S
PZP600166S PZP600467S PZP600529S PZP600638S PZP600134S PZP600135S PZP600172S
PZP600133S PZP600509S PZP600128S PZP600196S PZP600103S PZP600111S PZP600140S
PZP600142S PZP600169S PZP600527S PZP600611S PZP600636S PZP600656S PZP600614S
PZP600090S PZP600141S PZP600195S PZP600137S PZP600089S PZP600112S PZP600178S
PZP600127S PZP600173S PZP600211S PZP600213S PZP600511S PZP600524S PZP600577S
PZP600542S PZP600091S PZP600154S PZP600174S PZP600466S PZP600177S PZP600454S
PZP600455S PZP600456S PZP600457S PZP600458S PZP600459S PZP600462S PZP600463S
PZP600464S PZP600465S PZP600543S PZP600552S PZP600434S PZP600510S PZP600438S
PZP600439S PZP600584S PZP600221S PZP600521S PZP600180S PZP600544S PZP600604S
PZP600605S PZP600606S PZP600436S PZP600517S PZP600588S PZP600113S PZP600114S
PZP600115S PZP600116S PZP600117S PZP600118S PZP600119S PZP600120S PZP600121S
PZP600122S PZP600097S PZP600098S PZP600099S PZP600100S PZP600101S PZP600163S
PZP600164S PZP600165S PZP600448S PZP600197S PZP600200S PZP600202S PZP600203S
PZP600204S PZP600205S PZP600206S PZP600207S PZP600208S PZP600209S PZP600210S
PZP600136S PZP600550S PZP600637S PZP600568S PZP600109S PZP600586S PZP600159S
PZP600198S PZP600160S PZP600176S PZP600161S PZP600581S PZP600582S PZP600132S
PZP600108S PZP600168S PZP600170S PZP600214S PZP600512S PZP600526S PZP600545S
PZP600191S PZP600192S PZP600566S PZP600567S PZP600110S PZP600528S PZP600634S
PZP600155S PZP600126S PZP600129S PZP600130S PZP600131S PZP600148S PZP600123S
PZP600124S PZP600171S PZP600508S PZP600158S PZP600105S PZP600153S PZP600095S
PZP600094S PZP600167S PZP600212S PZP600547S PZP600538S PZP600216S PZP600217S
PZP600435S PZP600162S PZP600641S PZP600146S PZP600532S PZP600592S PZP600593S
PZP600594S PZP600595S PZP600143S PZP600144S PZP600555S PZP600556S PZP600618S
PZP600620S PZP600506S PZP600507S PZP600657S PZP600560S PZP600561S PZP600646S
PZP600649S PZP600654S PZP600107S PZP600104S PZP600147S PZP600615S PZP600617S
PZP600537S PZP600598S PZP600102S PZP600194S PZP600583S PZP600157S PZP600175S
PZP600087S PZP600088S PZP600444S PZP600575S PZP600576S PZP600151S PZP600106S
PZP600525S PZP600471S PZP600472S PZP600599S PZP600231S PZP600232S PZP600520S
PZP600226S PZP600453S PZP600541S PZP600229S PZP600230S PZP600522S PZP600523S
PZP600432S PZP600433S PZP600623S PZP600624S PZP600223S PZP600585S PZP600228S
PZP600653S PZP600225S PZP600179S PZP600182S PZP600183S PZP600184S PZP600185S
PZP600186S PZP600188S PZP600190S PZP600218S PZP600219S PZP600222S PZP600452S
PZP600629S PZP600632S PZP600437S PZP600539S PZP600224S PZP600573S PZP600574S
PZP600564S PZP600565S PZP600578S PZP600579S PZP600481S PZP600482S PZP600483S
PZP600484S PZP600442S PZP600621S PZP600622S PZP600580S PZP600551S PZP600644S
PZP600645S PZP600468S PZP600469S PZP600470S PZP600540S PZP600655S PZP600572S
PZP600625S PZP600553S PZP600554S PZP600440S PZP600626S PZP600628S PZP600630S
PZP600631S PZP600150S PZP600152S PZP600548S PZP600549S PZP600570S PZP600633S
PZP600518S PZP600597S PZP600145S PZP600563S PZP600139S and PZP600643S
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Mounds View, MN,
by letter dated July 30, 2008.
Manufacturer: Medtronic Puerto Rico Operations Company, Juncos, PR.
Firm initiated recall is ongoing.
REASON
Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management
algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The
Capture management algorithm monitors daily pacing thresholds and may increase
or decrease pacing amplitudes in response to patients' needs. Although the
algorithm is operating correctly, it is not accessible to the clinician for
reprogramming.
VOLUME OF PRODUCT IN COMMERCE
1,108 units
DISTRIBUTION
Countries of Austria, Denmark, Finland, Germany, Italy, Spain,
Sweden, UK, Greece, Hong Kong, India, Jordan and Saudi Arabia
___________________________________
PRODUCT
Stratus CS Acute Care Troponin I TestPak, Catalog number: CCTNI, in vitro diagnostic,
Recall # Z-0668-2009
CODE
Lot numbers: 238070002 exp 2008-09-06, 238077002 exp 2008-09-13, 238084002
exp 2008-09-20, 238091002 exp 2008-09-27, 238105002 exp 2008-10-11, 238112002
exp 2008-10-18, 238119002 exp 2008-10-25, 238126002 exp 2008-11-01, 238133002
exp 2008-11-08, and 238140002 exp 2008-11-15
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE, by letter dated June 23, 2008. Firm initiated
recall is complete.
REASON
Incorrect result: Potential for false elevation of CTnl results.
VOLUME OF PRODUCT IN COMMERCE
5,868 cartons
DISTRIBUTION
Nationwide and countries of Singapore, Saudi Arabia, Japan, Germany, Canada,
Bahrain, Australia, Korea, and India
___________________________________
PRODUCT
Hardy Diagnostic McFarland Standard 0.5; in vitro diagnostic, glass vial, one
vial per box. Model number: Hardy = MS05. Recall # Z-0669-2009
CODE
Lot number: 08182; Expiration date: 10/28/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trek Diagnostic Systems, Cleveland, OH, by letter on September
22, 2008.
Manufacturer: Hardy Diagnostics, Santa Maria, CA. Firm initiated recall is
ongoing.
REASON
Incorrect result: The absorbance has changed as the standards have aged; the
standards’ turbidity has become denser. The recalled lot is now reading
0.15 ABS @ 625 nm. TREK’S internal specification and the manufacturer’s
(Hardy Diagnostics) specification is 0.08 – 0.10 ABS @ 625 nm. CLSI specifies
0.08 – 0.13 ABS @ 625 nm.
VOLUME OF PRODUCT IN COMMERCE
4 vials
DISTRIBUTION
OH, IL
___________________________________
PRODUCT
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); The
Centricity PACS Workstation is intended for use as a primary diagnostic and
analysis tool for diagnostic images by trained healthcare professionals. It
is also intended for use as a clinical review workstation throughout the healthcare
facility. The workstation interface provides the user with a means to display,
manipulate, archive, print, and export images when connected with the Centricity
PACS infrastructure. Recall # Z-0836-2009
CODE
Software versions PACS 1.0CSR5/2.0CSR1 and all service packs
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated December
12, 2008. Firm initiated recall is ongoing.
REASON
There is a potential patient safety issue involving the use of the F12 keyboard
Approve & Complete function. The issue may cause erroneous information
to be added to a report when trying to approve and complete it.
VOLUME OF PRODUCT IN COMMERCE
138 units
DISTRIBUTION
Nationwide and countries of Canada, China, Denmark, Germany, Hong Kong, India,
Ireland, Italy, Japan, Korea, Lebanon, Mexico, Netherlands, Saudi Arabia, Spain,
Taiwan and United Kingdom
___________________________________
PRODUCT
a) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/18 cm, sterile;
Ref EUSCFS-060018-10-13; GPN REF G18116. Ureteral stent. Recall # Z-0839-2009;
b) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/20 cm, sterile; Ref EUSCFS-060020-10-13; GPN REF G18117. Ureteral stent. Recall # Z-0840-2009;
c) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/22 cm, sterile; Ref EUSCFS-060022-10-13; GPN REF G18118. Ureteral stent. Recall # Z-0841-2009;
d) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/24 cm, sterile; Ref EUSCFS-060024-10-13; GPN REF G18132. Ureteral stent. Recall # Z-0842-2009;
e) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile; Ref EUSCFS-060026-10-13; GPN REF G18119. Ureteral stent. Recall # Z-0843-2009;
f) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/28 cm, sterile; Ref EUSCFS-060028-10-13; GPN REF G18120. Ureteral stent. Recall # Z-0844-2009;
g) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/30 cm, sterile; Ref EUSCFS-060030-10-13; GPN REF G18121. Ureteral stent. Recall # Z-0845-2009;
h) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/18 cm, sterile; Ref EUSCFS-070018-14-13; GPN REF G18641. Ureteral stent. Recall # Z-0846-2009;
i) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/20 cm, sterile; Ref EUSCFS-070020-14-13; GPN REF G18123. Ureteral stent. Recall # Z-0847-2009;
j) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/22 cm, sterile;
Ref EUSCFS-070022-14-13; GPN REF G18133. Ureteral stent. Recall # Z-0848-2009;
k) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/24 cm, sterile;
Ref EUSCFS-070024-14-13; GPN REF G18125. Ureteral stent. Recall # Z-0849-2009;
l) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile; Ref EUSCFS-070026-14-13; GPN REF G18127. Ureteral stent. Recall # Z-0850-2009;
m) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/28 cm, sterile; Ref EUSCFS-070028-14-13; GPN REF G18134. Ureteral stent. Recall # Z-0851-2009;
n) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/30 cm, sterile; Ref EUSCFS-070030-14-13; GPN REF G18130. Ureteral stent. Recall # Z-0852-2009;
o) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile;
Ref EUSCFS-060026-10-13; GPN REF G18131. Ureteral stent. Recall # Z-0853-2009
CODE
a) Lot number: UF1560100;
b) Lot numbers: UF1565087, UF1401313, and UF1418996;
c) Lot numbers: UF1422329, UF1418997, UF1577105, UF1588937, UF1569283, UF1548852, UF1526279, UF1395329, UF1406376, UF1410869, UF1413150 and UF1385573;
d) Lot numbers: U1528861, U1542982, U1402436, U1361233, U1551529, U1391927, U1364946, U1347423, U1328716, U1416939, U1356437, U1525569, U1391927, U1328716, U1377093 and U1532644;
e) Lot numbers: U1368875, U1532226, U1541632, U1402438, U1356439, U1380409, U1418931, U1538110, U1362570, U1408480, U1411865, U1426173, U1527133, U1357612, U1416045, U1421059, UF1383702, UF1391074, U1426173 and U1525571;
f) Lot numbers: U1358169, U1346509, U1423782, U1342391, U1530194, U1532646, U1354142, U1412596, U1535132 and U1401255;
g) Lot number: UF1424956;
h) Lot number: UF1578018;
i) Lot number: UF1418998;
j) Lot numbers: UF1591697, UF1537682, UF1562307, UF1420730, UF1404622, UF1402891,
UF1531085, UF1526725, UF1396538, UF1406357, UF1533678, UF1542186, UF1570187,
UF1575838, UF1586147, UF1581083, UF1555888 and UF1389149;
k) Lot numbers: U1396476, U1352478, U1584786, U1342393, U1537634, U1530196, U1347425, U1398599, U1425757, U1391929, U1404166, U1360397, U1584786, U1412598, U1363042, U1391929, U1347425, UF1386555 and UF1387624;
l) Lot numbers: U1415656, U1392361, U1343299, U1416941, U1371126, U1363042, U1409768, U1405040, U1546157, U1414495, U1347427, U1551531, U1571113, U1533048, U1525573, U1535611 and U1409768S;
m) Lot numbers: UF1394511, UF1546568, UF1548011, UF1550302, UF1558381, UF1562308, UF1560070, UF1531086, UF1409854, UF1390546, UF1412673, UF1388726, UF1545756, UF1549848, UF1580601, UF1588492, UF1537146, UF1564616, UF1581084, UF1389605, UF1402894 and UF1404646;
n) Lot number: UF1406358;
o) Lot numbers: UF1537358 and UF1362608
RECALLING FIRM/MANUFACTURER
Vance Products, Inc., Spencer, IN, by letter dated July 31, 2008. Firm initiated
recall is ongoing.
REASON
The bond may break where the two materials meet, resulting in separation of
the stent.
VOLUME OF PRODUCT IN COMMERCE
1,739 sets
DISTRIBUTION
Nationwide, Australia, Canada, Colombia, Hong Kong, India, Ireland, Israel,
Japan, Malaysia, Mexico, South Korea, Taiwan, Venezuela and Viet Nam
___________________________________
PRODUCT
Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only;
Catalog number: R6357A (12 mm), Catalog number: R6397A (16 mm). Recall # Z-0854-2009
CODE
Lot number: 326081; and Lot number: 327081
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letters on October
22, 2008 and January 5, 2009.
Manufacturer: Instrumed International, Inc., Schaumburg, IL. Firm initiated
recall is ongoing.
REASON
A packaging error had occurred where 16 mm screws were packaged and labeled
as 12 mm screws and vice versa.
VOLUME OF PRODUCT IN COMMERCE
351 - 12 mm screws
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and
Transducer Protectors, with Access Flow Reversing Connector (Twister) Product
Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection
site, viral-retentive transducer protectors, & priming set & Twister
device. Recall # Z-859-2009;
b) CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and
Transducer Protectors, with Access Flow Reversing Connector (Twister) Product
Code: 03-2794-0 Bonded CombiSets - includes priming set w/ needleless access
port & Y-injection site bonded to arterial line, viral-retentive transducers
and Twister device, Recall # Z-860-2009
CODE
a) Lot number: 8LR902;
b) Lot numbers: 8ER273, 8HR038, 8JR021, 8KR013, 8LR013, 8ER283, 8HR066, 8JR075,
8KR032, 8LR020, 8HR114, 8JR136, 8KR060, 8LR048, 8HR125, 8JR142, 8KR113, 8LR074,
8HR189, 8JR167, 8KR131, 8LR123, 8HR207, 8JR193, 8KR159, 8LR209, 8HR225, 8JR209,
8KR170, 8LR909, 8HR241, 8JR222, 8KR200, 8HR266, 8JR266, 8KR210, 8HR285, 8KR228,
8KR250, and 8KR271
RECALLING FIRM/MANUFACTURER
Fresenius Medical Care North America, Waltham, MA, by e-mail and telephone
on November 25, 3008, and by letters on November 26, 2008, December 2, 2008
and December 3, 2008. Firm initiated recall is ongoing.
REASON
Port may crack and separate resulting in potential blood exposure/blood loss
for the patient.
VOLUME OF PRODUCT IN COMMERCE
351,800 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional
- Articular surface, Size Blue, 14 MM Height, nonsterile; REF 5971-50-14. Used
during total knee arthroplasty surgery to determine the required thickness
of the tibial bearing surface to be implanted. Reusable, non-implantable. Recall
# Z-0885-2009;
b) Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional
- Articular surface, Size Blue, 12 MM Height, nonsterile; REF 5971-50-12. Used
during total knee arthroplasty surgery to determine the required thickness
of the tibial bearing surface to be implanted. Reusable, non-implantable. Recall
# Z-0886-2009
CODE
a) Lot numbers: 60969810 and 60969811;
b) Lot numbers: 61007188, 60987590, 60969807, 60976981 and 60976982
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated December 12, 2008 and by e-mail on
December 15, 2008. Firm initiated recall is ongoing.
REASON
Some 12 mm thick devices may have been etched and packaged as 14 mm thick,
and vice versa.
VOLUME OF PRODUCT IN COMMERCE
131 devices
DISTRIBUTION
Nationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United
Kingdom
___________________________________
PRODUCT
a) Expressaire, Disposable Tourniquet Cuff 34", 1 line (18), sterile;
Cuff type A70107010. Each cuff is marked ExpressAire by Sammons Preston and
A70107010. The tourniquet cuff is placed on a patient's thigh during an operation
procedure of the lower leg. The cuff is not operational until it is attached
to an air pump supply that is owned by the care giving facility (hospital).
Recall # Z-0907-2009;
b) Expressaire, Disposable Tourniquet Cuff 34", 2 line (18), sterile;
Cuff type A70107011. Each cuff is marked ExpressAire by Sammons Preston and
A70107011. The tourniquet cuff is placed on a patient's thigh during an operation
procedure of the lower leg. The cuff is not operational until it is attached
to an air pump supply that is owned by the care giving facility (hospital).
Recall # Z-0908-2009
CODE
a) Lot numbers: SO590, SO1205, and SO1300;
b) Lot numbers: SO1106, SO2202, SO2227, and SO2232
RECALLING FIRM/MANUFACTURER
Virtus, Inc., Batesville, IN, by letter dated November 24, 2008. Firm initiated
recall is ongoing.
REASON
The inflation tube may come loose at the connection to the cuff during use.
VOLUME OF PRODUCT IN COMMERCE
5,958 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Somatom Definition AS, Model number: 8098027. Computed tomography x-ray system.
Recall 3 Z-0929-2009
CODE
Serial numbers: 64064, 64065, 64067, 64068, 64071, 64074, 64077, 64078, 64081,
64085, 64087, 64091, 64097, 64103, 64104, 64105, 64111, 64112, 64113, 64114,
64115, 64117, 64118, 64122, 64123, 64138, 64140, 64142, 64145, 64154, 64164,
64166, 64168, 64169, 64170, 64171, 64172, 64177, 64179, 64180, and 64181
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter
dated November 25, 2008.
Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated
recall is ongoing.
REASON
Possible improper installation of tilt transport lock/tilt limiter.
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL
SURGERY, Original OBWEGESER Instruments. NOTE: None distributed domestically.
Cranio-maxillofacial manual instrumentation to be used to aid in the treatment
and care of patients, as determined appropriate, by a trained medical professional.
The Obwegeser Ramus Clamps are self-retaining clamps, used on the ascending
ramus of the mandible with an extension on one of the blades (shields) to aid
in retracting the soft tissue of the cheek. Recall # Z-0906-2009
CODE
Lot Number: 050801
RECALLING FIRM/MANUFACTURER
Biomet Microfixation, Inc., Jacksonville, FL, by e-mail on May 21, 2008. Firm
initiated recall is complete.
REASON
The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly
etched as the left part number 01-7997.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Ireland, Japan
___________________________________
PRODUCT
AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm.
AMS InteXen LP is a sterile non-perforated processed porcine collagen dermal
matrix. Sterile EO. The AMS collagen dermal matric is intended for use in the
treatment of hernias where connective tissue has ruptured or for implantation
to reinforce soft tissues where weakness exists in the urological, gynecological,
or gastroenterological anatomy. Recall # Z-0932-2009
CODE
Lot/serial numbers: 567398002, 567398003
RECALLING FIRM/MANUFACTURER
American Medical Systems, Inc., Minnetonka, MN, by telephone on December 5,
2008. Firm initiated recall is ongoing.
REASON
The product size shown on the carton labeling does not match the size on the
product inside.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Bard 3D Max Mesh, Left large , Sterile Pre-formed Knitted Polypropylene Product
Code: 0151531. Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene
mesh indicated for use in the repair of hernias and chest wall defects. It
is designated in two orientations - "Right" and "Left" for
use to the right or left side of the human body. There is a blue monofilament
Medial marker "M" and a small arrow stitched into each orientation
to designate the right or left medial edge of the product. Recall # Z-0935-2009
CODE
Lot number: 43JQD016
RECALLING FIRM/MANUFACTURER
Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, by letter
dated December 25, 2008.
Manufacturer: Bard Shannon Limited, Humacao, PR. Firm initiated recall
is ongoing.
REASON
Mislabeled; Product labeled as left large, may contain a Right Large.
VOLUME OF PRODUCT IN COMMERCE
232 units
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR FEBRUARY 4, 2009
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