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U.S. Department of Health and Human Services

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Enforcement Report for February 18, 2004

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 18, 2004
04-07

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Sun Dried Yellow Tomato, 12 oz, packaged in plastic
Overwrapped Styrofoam tray, 6 trays per case. UPC CODE
68891400248. Recall # F-094-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Coosemans Dc Inc, Washington, DC, by press release and letter on December 30, 2003, and recall notification on December 31, 2003. New York State initiated recall is complete.
REASON
Sun dried tomatoes contain sulfites which are undeclared on the label.
VOLUME OF PRODUCT IN COMMERCE
40 cases.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Atlantis Salmon Spread, a mixture of smoked salmon, cream
cheese and other ingredients packed into 8 oz and 24 oz
plastic containers. Recall # F-095-4.
CODE
Lot number 308-1, Expiration January 8, 2004 and
Lot number 324-1, Expiration January 24, 2004. Dates are stamped on the bottom of containers.
RECALLING FIRM/MANUFACTURER
Atlantis Seafood, Lantana, FL, by email on December 9, 2003. FDA initiated recall is complete.
REASON
The product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Lot number 308-1: 130 cases of 3-8 oz, 20 cases of 12-8 oz, 90 cases of 6-24 oz;
Lot number 324-1: 30 cases of 12-8 oz and 50 cases of 6-24 oz.
DISTRIBUTION
FL, GA, and DE.
______________________________
PRODUCT
Queijo Mineiro, a soft natural cheese, Brazil Specialty.
The product is sold in 1 lb packages. Recall # F-096-4.
CODE
All product through sell by date ll/3/04.
RECALLING FIRM/MANUFACTURER
Leraysville Cheese Factory, Leraysville, PA, by telephone on October 3, 2003, and by press release on October 7, 2003. FDA initiated recall is complete.
REASON
Soft Natural Cheese is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
4,758 units.
DISTRIBUTION
NJ and NY.

_______________________________
PRODUCT
Ground Sage packed in brown paper bags weighing approximately 50 lbs. each. Product was imported from Turkey. Recall # F-118-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Wm. E. Martin & Sons Co., Inc., Jamaica, NY, by telephone on August 22, 2003. FDA initiated recall is complete.
REASON
FDA's analysis revealed that the product was contaminated with Salmonella spp. Poly A group B.
VOLUME OF PRODUCT IN COMMERCE
2 bags.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Dried Green Raisins, Net Wt. 12.5 Kg (27.5 lb). Product was packaged in a plastic lined cardboard box. Kadouri International relabeled the product with stick-on labels and distributed the product as Pakistani Green Raisins' (Kishmish). Recall # F-119-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Global Commodities, Inc., College Point, NY, by letter dated July 17, 2003 and by press release on July 18 and 21, 2003, and by telephone, and letter on July 18, 2003. New York State initiated recall is complete.
REASON
The product contains undeclared sulfites based on NYSDAM sampling & analysis.
VOLUME OF PRODUCT IN COMMERCE
80 cartons.
DISTRIBUTION
NY, NJ, PA, and CT.

_______________________________
PRODUCT
Stop and Shop brand store-packaged assorted Party Cookies,
16 oz., packaged in a clear plastic container.
Recall # F-120-4.
CODE
All date codes on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Stop & Shop Companies, Inc., Quincy, MA, by e-mail on December 11, 2003. Firm initiated recall is complete.
REASON
Label of cookies bears a partial ingredient statement. Undeclared ingredients include cashews, pecan meal/pecans, Brazil nut meal, filberts, and sesame seeds.
VOLUME OF PRODUCT IN COMMERCE
6,761 units.
DISTRIBUTION
CT, MA, NH, NY, NJ, and RI.
 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
King Kullen Raspberry Seltzer 2 Liter bottles. The label
states that the product is sodium free and artificially
flavored. The product is shipped in cases that contain 8
bottles. Recall # F-121-4.
CODE
03072, 03167, and 03201.
RECALLING FIRM/MANUFACTURER
Cott Beverages Wyomissing Inc., Wyomissing, PA, by telephone and email and a recall notification dated August 13, 2003. Firm initiated recall is complete.
REASON
The product is contaminated with mold.
VOLUME OF PRODUCT IN COMMERCE
3,652 cases.
DISTRIBUTION
CT and NY.
 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Paremyd Ophthalmic Solution (hydroxyamphetamine
hydrobromide/tropicamide ophthalmic solution), 1%/0.25%,
Sterile, in 15mL low density polyethylene bottle, Rx only.
Recall # D-081-4.
CODE
Lot 3C19A, Exp. Date 02/05; Lot 3C28A, Exp. Date 02/05; Lot 2L86A, Exp. Date 10/04.
RECALLING FIRM/MANUFACTURER
Akorn Inc., Buffalo Grove, IL, by letter dated October 27, 2003. Firm initiated recall is ongoing.
REASON
Products degradation level exceeds specification (6 month stability).
VOLUME OF PRODUCT IN COMMERCE
26,439 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) CombiPatch Transdermal System, (estradiol/norethindrone
acetate transdermal system), 0.05/0.14mg per day, 3
patient packs of 8 systems, 8 systems per patient pack
(inner carton), and physician samples (4 x 2's) and
(1 x 2's). Recall # D-089-4;
b) CombiPatch Transdermal System, (estradiol/norethindrone
acetate transdermal system) 0.05/0.25mg per day, 3
patient packs of 8 systems, 8 systems per patient pack
(inner carton), and physician samples (4 x 2's) and (1
x 2's), Rx Only, Recall # D-090-4.
c) Vivelle-dot (estradiol transdermal system),
0.0375mg/day, cartons of 3 patient packs of 8 systems, 8
systems per patient pack (inner carton), Rx Only.
Recall # D-091-4;
d) Vivelle-dot (estradiol transdermal system), 0.05mg/day,
3 patient packs of 8 systems, 8 systems per patient pack
(inner carton), 5 patient packs of 2 systems, Individual
patient packs of 2, Rx Only. Recall # D-092-4;
e) Vivelle-Dot (estradiol transdermal system), 0.1mg/day, 3
patient packs of 8 systems, 8 systems per patient pack
(inner carton), Rx Only. Recall # D-093-4.
CODE
a) Lot Number/Expiration Date: 6018101 (November 2003);
6019101 (November 2003); 6077101 (January 2004); 6078101
(January 2004); 61091011 (May 2004); 61931011 (June
2004); 62271011 (August 2004); 62281011 (August 2004);
62731011 (August 2004); 61101011 (May 2004) (physician
samples);
b) Lot Number/Expiration Date: 60791011( February 2004);
60801011 (February 2004); 61081011 (February 2004)
(physician samples);
c) Lot Number/Expiration Date: 62591011 (August 2004);
d) Lot Number/Expiration Date: 65851011 (September 2004);
65861011 (September 2004); 65861021 (September 2004);
Lot 65141012 (August 2004) (physician samples);
e) Lot Number/Expiration Date: 62631011 (August 2004).
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals, Corp., Suffern, NY, by letter on November 13, 2003, and December 2, 2003. Firm initiated recall is ongoing.
REASON
OOS for estradiol and norethindrone acetate potency and impurities due to packaging components. (Stability failure).
VOLUME OF PRODUCT IN COMMERCE
723,639.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
BiCNU (carmustine for injection), Formerly known as (sterile carmustine [BCNU], 100 mg and Diluent, Rx only. Recall # D-108-4.
CODE
Lot Number LKM11, Exp. Date October 31, 2004.
RECALLING FIRM/MANUFACTURER
Bristol Myers Squibb Co. C.P.O., Mount Vernon, IN, by letter on December 24, 2003. Firm initiated recall is ongoing.
REASON
Subpotent: (24 month stability testing).
VOLUME OF PRODUCT IN COMMERCE
21,770.
DISTRIBUTION
Nationwide, Dominican Republic, Ecuador, Lebanon, Peru, and the Phillippines.
 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
BOCA PHARMACAL, INC FE C Tab Plus, (Carbonyl Iron 100 mg, Vitamin C (Ascorbic Acid) 250 mg, Vitamin B-12 (Cyanocobalamin) 25 mcg, Folic Acid 1 mg), Rx only. Recall # D-109-4.
CODE
Lot Number: 18317, Expiration Date: (10/2005).
RECALLING FIRM/MANUFACTURER
Gemini Pharmaceuticals, Inc., Commack, NY, by telephone on January 22, 2004 and letter on January 27, 2004. Firm initiated recall is ongoing.
REASON
Mislabeling: Tablets lack the identifying debossment (ID# "G-3") on one side.
VOLUME OF PRODUCT IN COMMERCE
5,000 bottles.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0647-4.
CODE
Unit 042J46996.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone on October 21, 2003, and by letter dated October 22, 2003. 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
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0648-4;
b) Platelets, Leukocytes Reduced. Recall # B-0649-4.
CODE
a) and b) Unit 042X73012.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone on November 6, 2003, and by letter dated November 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0675-4;
b) Platelets, Leukocytes Reduced. Recall # B-0676-4.
CODE
a), and b) Unit number 33GL21535.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone on November 5, 2003, and by letter on November 6, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CT, PA, and CA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0692-4;
b) Recovered Plasma. Recall # B-0693-4.
CODE
a) and b) Unit GH24820.
RECALLING FIRM/MANUFACTURER
Inova Heath System, Blood Donor Services, Annandale, VA, by letter dated November 5, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0694-4;
b) Recovered Plasma, Recall # B-0695-4.
CODE
a) and b) Units (2 units) T36877, C52923.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by letter dated October 14, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0696-4;
b) Platelets. Recall # B-0697-4;
c) Fresh Frozen Plasma. Recall # B-0698-4.
CODE
a), b), and c) Unit number T47785.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by letter dated September 12, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose sexual partner had resided in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-0702-4.
CODE
Unit numbers 5476105A and 5476105B.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Eastern Maine Medical Center,
Bangor, ME, by telephone on July 11, 2003. Firm initiated recall is complete.
REASON
Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
ME.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0703-4;
b) Fresh Frozen Plasma. Recall # B-0704-4.
CODE
a) and b) Unit numbers 5476258.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Eastern Maine Medical Center,
Bangor, ME, by telephone and letter on October 2, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of Crohn's disease and medication with the drug Asacol, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
ME.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0705-4;
b) Fresh Frozen Plasma, Recall # B-0706-4.
CODE
a) and b) Unit number 9161629.
RECALLING FIRM/MANUFACTURER
Vermont Blood Center, Williston, VT, by telephone on May 30, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VT.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0708-4.
CODE
Unit number R52197 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on September 10, 2003. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0709-4;
b) Platelets. Recall # B-0710-4.
CODE
a) and b) Unit number R59006.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by letter on August 18, 2003, and by facsimile on August 20, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Units.
DISTRIBUTION
VA.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0677-4.
CODE
Unit number 33GL21535.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone on November 5, 2003, and by letter on November 6, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT, PA, and CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0678-4.
CODE
Units 153960907 (2 units), 153961336, 153960904, 153961335, 153960698, 153960696 (2 units), 153960908, and 153960697.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by letter dated February 14, 2003. Firm initiated recall is complete.
REASON
Blood products, which were stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0679-4;
b) Recovered Plasma, Recall # B-0680-4.
CODE
a) and b) Unit 33GS34695.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone and by letter on November 21, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA, and CT.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0681-4;
b) Platelets Leukocytes Removed, Recall # B-0682-4;
c) Recovered Plasma, Recall # B-0683-4.
CODE
a), b) and c) Unit 33GE59239.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone and by letter on December 1, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA, CA, and CT.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0684-4;
b) Platelets Leukocytes Removed, Recall # B-0685-4;
c) Recovered Plasma, Recall # B-0686-4.
CODE
a), b) and c) Unit 33GE14908.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on November 26, 2003, and by letter dated December 1, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA, CA, and CT.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0687-4;
b) Platelets Leukocytes Removed, Recall # B-0688-4;
c) Recovered Plasma, Recall # B-0689-4.
CODE
a), b) and c) Unit 33GT31503.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone and by letter dated December 1, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA, and CT.

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0690-4.
CODE
Unit 33FF07515.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on November 10, 2003, and by letters dated November 26, and December 30, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0691-4.
CODE
Unit number: FC44228.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by facsimile on October 23, 2003. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the donor reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0699-4.
CODE
Unit numbers: J15585/1, J15587/1, J15589/1, J15593/1,
J15609/1, J15614/1, J15621/1, J15625/1, J15627/1, J15629/1,
J15630/1, J15631/1, J15641/1, J15647/1, J15651/1, J15656/1,
J15660/1, J15661/1, J15666/1, J15688/1, J15698/1, J15710/1,
J15713/1, J15714/1, J15716/1, J15720/1, J15721/1, J15722/1,
J15723/1, J15724/1, J15725/1, J15726/1, J15728/1, J15729/1,
J15757/1, J15780/1, J15787/1, J15793/1, J15799/1, J15800/1,
J15804/1, J15807/1, J15828/1, J15831/1, J15832/1, J15833/1,
J15838/1, J15840/1, J15842/1, J15850/1, J15852/1, J15862/1,
J15863/1, J15867/1, J15869/1, J15868/1, J15870/1, J15872/1,
J15875/1, J15876/1, J15879/1, J15880/1, J15881/1, J15903/1,
J15907/1, J15916/1, J15918/1, J15921/1, J15927/1, J15930/1,
J15938/1, J15939/1, J15940/1, J15944/1, J15948/1, J15951/1,
J15955/1, J15960/1, J15962/1, J15956/1, J15959/1, J15963/1,
J15965/1, J15968/1, and J15970/1.
RECALLING FIRM/MANUFACTURER
Johnston Memorial Hospital, Abingdon, VA, by letters, dated May 14, 2003 and June 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
85 Units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Source Plasma, Recall # B-0707-4.
CODE
Unit number 53-DDPMWH-A.
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Melrose Park, IL, by facsimile on October 22, 2003. 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
TN.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
AG-920RA Multi-gas unit analyzer. Recall # Z-0506-04.
CODE
Serial numbers 00001 to 00020, 00022, 00023, 00024, 00029.
RECALLING FIRM/MANUFACTURER
Nihon Kohden America Inc., Foothill Ranch, CA, by letter, on December 5, 2003. Firm initiated recall is complete.
REASON
Manufacturing error results in screw affecting electromagnetic interferences.
VOLUME OF PRODUCT IN COMMERCE
24.
DISTRIBUTION
CA, OK, and NV.

_______________________________
PRODUCT
CryoValve, Pulmonary Valve & Conduit. Recall # Z-0516-04.
CODE
Donor number: 71237, Serial number: 8214013, Model number: PV00.
RECALLING FIRM/MANUFACTURER
Cryolife Inc., Kennesaw, GA, by telephone on November 11, 2003, and by letter sent December 10, 2003. Firm initiated recall is ongoing.
REASON
The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) LAERDAL Silicone Resuscitator (LSR), Adult size,
containing Intake/Reservoir Valve. Sold as Part Nos:
870050-Adult Basic w/o Mask in Carton; 870051-Adult
Complete in Carton; 870052-Adult Standard with Adult
Mask 4-5+ in Carton; 870053-Adult Complete in Compact
Case; 870055-Adult Complete in Display Case; 875500-
b) Adult Update Kit. Recall # Z-0517-04;
LAERDAL Silicone Resuscitator (LSR), Pediatric Size,
containing an Intake/Reservoir Valve. Sold as Part Nos:
860050-Pediatric Basic w/o Mask in Carton; 860051-
Pediatric Complete in Carton; 860052-Standard Child
w/Child Mask 3-4 in Carton; 860053-Pediatric Complete in
Compact Case; 860055-Pediatric Complete in Display Case;
860056-Standard Term-Baby w/Infant Mask 0-1 in Carton;
865500-Pediatric Upgrade Kit. Recall # Z-0518-04;
c) LAERDAL Silicone Resuscitator (LSR), Preterm Size,
containing an Intake/Reservoir Valve. Sold as Part Nos:
850050-Preterm Basic w/o Mask in Carton; 850051-Preterm
Complete in Carton; 850053-Preterm Complete in Compact
Case; 850055-Preterm Complete in Display Case; 855500-
Preterm Update Kit. Recall # Z-0519-04;
d) Intake/Reservoir Valve (Part No. 875400), used in all
sizes of Laerdal Silicone Resuscitators.
Recall # Z-0520-04.
CODE
a) All product shipped after 1/29/2003 is affected. The
following lot numbers are the lot numbers for adult,
pediatric and preterm size LSR: 0403, 0703, 0803, 0903,
1003, 1103, 1203, 1303, 1403, 1503, 1603, 1703, 1803,
1903, 2003, 2103, 2203, 2303, 2503, 2703, 2903, 3103,
3203, 3303, 3503, 3603, 3703, 3803, 3903, 4003, 4103,
4203, 4303, 4403, 4503, 4603, 4703, 4803, 4903. NOTE:
customers were NOT provided with lot numbers. They were
instructed to visually examine the Intake/Reservoir
valve in order to determine if they have affected
product.
b) All product shipped after 1/29/2003 is affected. The
following lot numbers are the lot numbers for adult,
pediatric and preterm size LSR: 0403, 0703, 0803, 0903,
1003, 1103, 1203, 1303, 1403, 1503, 1603, 1703, 1803,
1903, 2003, 2103, 2203, 2303, 2503, 2703, 2903, 3103,
3203, 3303, 3503, 3603, 3703, 3803, 3903, 4003, 4103,
4203, 4303, 4403, 4503, 4603, 4703, 4803, 4903. NOTE:
customers were NOT provided with lot numbers. They were
instructed to visually examine the Intake/Reservoir
valve in order to determine if they have affected
product.
c) All product shipped after 1/29/2003 is affected. The
following lot numbers are the lot numbers for adult,
pediatric and preterm size LSR: 0403, 0703, 0803, 0903,
1003, 1103, 1203, 1303, 1403, 1503, 1603, 1703, 1803,
1903, 2003, 2103, 2203, 2303, 2503, 2703, 2903, 3103,
3203, 3303, 3503, 3603, 3703, 3803, 3903, 4003, 4103,
4203, 4303, 4403, 4503, 4603, 4703, 4803, 4903. NOTE:
customers were NOT provided with lot numbers. They were
instructed to visually examine the Intake/Reservoir
valve in order to determine if they have affected
product.
d) Lot numbers were not provided. All product shipped after
1/29/2003 is affected. Customers need to visually
examine the Intake/Reservoir valve in order to determine
if they have affected product.
RECALLING FIRM/MANUFACTURER
Laerdal Medical Corporation, Wappingers Falls, NY, by letters on January 14, 2004. Firm initiated recall is ongoing.
REASON
Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.
VOLUME OF PRODUCT IN COMMERCE
5,421 pieces.
DISTRIBUTION
Nationwide, and Internationally.

_______________________________
PRODUCT
Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029. Recall # Z-523-04.
CODE
Lot Number: 160760 Expiration Date: 2006-12.
RECALLING FIRM/MANUFACTURER
Medtronic, Inc., Danvers, MA, by telephone and email on January 14, 2004. Firm initiated recall is ongoing.
REASON
Catheter distal tip may separate.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
NC, and WA.

_______________________________
PRODUCT
a) Stryker brand Adel Maternity bed, model 4700, with night
light. Recall # Z-0524-04;
b) Stryker brand Firstcare Ultra Maternity bed, model 5010,
with night light. Recall # Z-0525-04;
c) Stryker brand Firstcare Ultra Maternity bed and Stryker
brand Adel Maternity bed, 220 volt, model 5012, with
night light. Recall # Z-0526-04.
CODE
a) All beds manufactured between August 1, 2000 and
December 23, 2003;
b) and c) All beds manufactured between January 1, 1997 and
December 23, 2003.
RECALLING FIRM/MANUFACTURER
Stryker Medical, Kalamazoo, MI, by letters dated January 21, 2003. Firm initiated recall is ongoing.
REASON
A potential shock hazard exists if the night light is damaged.
VOLUME OF PRODUCT IN COMMERCE
2,396.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Synergraft CryoValve, Aortic Valve & Conduit SG.
Donor #60525, Model #SGAV00. Recall # Z-0528-04;
b) CryoValve, Pulmonary Valve & Conduit. Donor #69666,
Model #PV00. Recall #Z-0529-04;
c) CryoValve, Aortic Valve & Conduit. Donor #69666,
Model #AV00. Recall # Z-0530-04.
CODE
a) Serial # 7759189;
b) Serial # 8008568;
c) Serial # 8008559.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on January 16, 2004. Firm initiated recall is ongoing.
REASON
Microorganisms were detected in associated tissue.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA, MI, and OK.

_______________________________
PRODUCT
a) Esaote brand Archimed 4220 ECG System; part 9704220000.
Recall # Z-0532-04;
b) Esaote brand Formula for Archimed ECG System; part
9704220000. Recall # Z-0533-04;
c) Esaote brand ArchiWin Colour ECG System; part
9704325000. Recall # Z-0534-04;
d) Esaote brand Formul@ ECG System; part 9704220000.
Recall #Z-0535-04.
CODE
a) Serial numbers: 110, 124, 125, 128, 131, 137, 189, 258,
325, 513, 514, 521, 522, 523, 525, 696, 877, 835, 836,
837, 1089, 1090, 1091, 1096, 1138, 1419, 1466 and 1467;
b) Serial numbers: 103, 106, 107, 108, 129, 135, 136, 197,
205, 242, 270, 348, 361, 373, 420, 441, 462, 464, 520
and 522;
c) Serial number 149;
d) Serial numbers 157 and 158.
RECALLING FIRM/MANUFACTURER
Esaote Biomedica S.P.A., Indianapolis, IN, by letter dated December 23, 2003. Firm initiated recall is ongoing.
REASON
If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient.
VOLUME OF PRODUCT IN COMMERCE
51.
DISTRIBUTION
CA, FL, IN, KY, Brazil, Colombia and Japan.

_______________________________
PRODUCT
Pump Tube, Suction Pump Drain Tube; An accessory to the suction pump designed for use with the Richard Wolf Ultrasound Lithotriptor used to disintegrate kidney stones, urinary bladder stones and ureter stones. Recall # Z-0537-04.
CODE
Part number 8170.121. There is no lot number or production code.
RECALLING FIRM/MANUFACTURER
Richard Wolf Medical Instruments Corp., Vernon Hills, IL, by telephone on February 2, 2004. Firm initiated recall is ongoing.
REASON
If the drain tube is assembled incorrectly, the suction pump will not operate as intended.
VOLUME OF PRODUCT IN COMMERCE
2 tubing sets.
DISTRIBUTION
TX, and NE.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
a) Magnetom Trio System. Nuclear Magnetic Resonance Imaging
Diagnostic Device. Recall # Z-0521-04.
b) Magnetom Allegra System. Nuclear Magnetic Resonance
Imaging Diagnostic Device. Recall # Z-0522-04.
CODE
a) Model #7387074 - Serial #'s: 20501 through 20508, 20510
through 20524, and 20550 through 20570. Model #7106441 -
Serial # 20500.
b) Model #7106433 - Serial #'s 20101 through 20113.
Model #7387736 - Serial #'s 20405, 20406, 20411, 20412,
and 20419.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by visit beginning December 18, 2003. Firm initiated recall is ongoing.
REASON
Tissue roll can become magnetic.
VOLUME OF PRODUCT IN COMMERCE
32 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version BIA. Recall # Z-0527-04.
CODE
S/Ns: 100 thru 105, and 107 thru 116.
RECALLING FIRM/MANUFACTURER
GVI Technology Partners, Twinsburg, OH, by letter on January 16, 2004. Firm initiated recall is ongoing.
REASON
Due to limitations in the operating software, the acquired scan may not be processed properly.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
PA, OH, FL, and SC.

_______________________________
PRODUCT
Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software. Recall #Z-0531-04.
CODE
All software versions 5.0A and 5.0B.
RECALLING FIRM/MANUFACTURER
Medtronic MiniMed, Northridge, CA, by Product Performance Update labeling in new shipments, starting on January 28, 2004. Firm initiated recall is ongoing.
REASON
A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software.
VOLUME OF PRODUCT IN COMMERCE
Undisclosed.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Four Shooter Saeed Multi-Band Ligator. Reorder/Catalog number MBL-4XL. Recall # Z-0536-04.
CODE
Lot W1842922.
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc., Winston Salem, NC, by letter on January 19, 2004. Firm initiated recall is ongoing.
REASON
Product label lacks the symbols specifying the meaning of the manufacturing and expiration date.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.

END OF ENFORCEMENT REPORT FOR February 18, 2004

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