Enforcement Report

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

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December 13, 2006
06-50

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

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PRODUCT
Wegmans Italian Classics Lemon & Caper Sauce, 11 OZ. 311g, UPC barcode 0 77890 55112 7, Recall # F-076-7
CODE
Use by date 11/05/07. The use by date is located on the shoulder of the jar.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wegmans Food Markets, Rochester,NY, by a press release and e-mail on 11/14/06
Manufacturer: LiDestri Foods, FairportNY. Firm initiated recall is ongoing.
REASON
The product contains glass fragments.
VOLUME OF PRODUCT IN COMMERCE
1,893 cases (12 count per case)
DISTRIBUTION
MD, NJ, NY, PA, and VA

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
Nystatin Topical Powder, USP, 100,000 units per gram, Rx Only, 30 grams bottles, NDC 67767-112-16, Recall # D-406-7
CODE
Lot 5C503
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coastal Pharmaceuticals, Inc, GreenvilleNC, by email on August 3, 2006 and by letter on August 9, 2006.
Manufacturer: Metrics Inc, Greenville,NC. Firm initiated recall is ongoing.
REASON
Subpotent (12 month stability)
VOLUME OF PRODUCT IN COMMERCE
2,693 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall B-0372-7;
b) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall B-0373-7;
c) Fresh Frozen Plasma, Recall B-0374-7
CODE
a) Units: 26730-7953, 26730-7964, 26731-8556, 26731-2251, 26731-2272, 26731-2288,
26731-2290, 26731-2327, 26731-2393, 26731-2400, 26731-2408, 26731-2413,
26731-2419, 26731-2425, 26731-2451, 26731-2462, 26731-2514, 26731-2529,
26731-2538, 26731-2603, 26731-2610, 26731-2626, 26731-2661, 26731-2671,
26731-2797, 26731-2804, 26731-2808, 26731-2811, 26731-2818, 26731-2828,
26731-2841, 26731-2845, 26731-2847, 26731-2848, 26731-2903, 26731-2948,
26731-2954, 26731-2957, 26731-2984, 26731-2988, 26731-2997, 26731-2998,
26731-3062, 26731-3063, 26731-3071, 26731-3075, 26731-3137, 26731-3138,
26731-3153, 26731-3159, 26731-3166, 26731-3173, 26731-3186, 26731-3292,
26731-3368, 26731-3371, 26731-3381, 26731-3432, 26731-3602, 26731-3603,
26731-3610, 26731-3621, 26731-3675, 26731-3685, 26731-3689, 26731-3701,
26731-3708, 26731-3735, 26731-3766, 26731-3769, 26731-3841, 26731-3842,
26731-3846, 26731-3857, 26731-3873, 26731-3893, 26731-3918, 26731-3977,
26731-3988, 26731-3998, 26731-4000, 26731-4007, 26731-4015, 26731-4046,
26731-4054, 26731-4071, 26731-4116, 26731-4144, 26731-4181, 26731-4189,
26731-4208, 26731-4223, 26731-4280, 26731-4283, 26731-4286, 26731-4331,
26731-4366, 26731-4405, 26731-4416, 26731-4446, 26731-4494, 26731-4509,
26731-4515, 26731-4516, 26731-4521, 26731-4522, 26731-4524, 26731-4526,
26731-4531, 26731-4671, 26731-4695, 26731-4709, 26731-4717, 26731-4756,
26731-4820, 26731-4949, 26731-4988, 26731-5169, 26731-6212, 26731-6244,
26731-6255;
b) Unit: 26731-3641;
c) Units: 26731-2288, 26731-2290, 26731-2425, 26731-2696
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone between November 20, 2004 and December 2, 2004. Firm initiated recall is completed.
REASON
Blood products, that lacked assurance of sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
126 units
DISTRIBUTION
AK, PA, OK, and TX

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0410-7
CODE
Unit: 2066003
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone and facsimile on September 5, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Micrococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

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PRODUCT
a) Fresh Frozen Plasma, Recall # B-0443-7;
b) Recovered Plasma, Recall # B-0444-7
CODE
a) Unit: R27179;
b) Unit: S84014
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by, fax and internet on June 22, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI and Switzerland

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0446-7
CODE
Unit: 5861366
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by facsimile transmission dated
March 23, 2006. Firm initiated recall is complete.
REASON
Red Cells, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

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PRODUCT
Source Plasma, Recall # B-0455-7
CODE
Units: HZ024794, HP138660, HZ024592, HZ024508, HP137286, HZ023858, HZ023775, HZ023592, HP135652, HZ023308, HP135126, HZ022929, HZ022491, HZ022172, 05CILB9740, 05CILB9484, 05CILB9159, 05CILB8981, HZ021146, HZ021005, HZ020704, 05CILB7848, 05CILB7359, 05CILB7136, HZ019764, HZ019461, 05CILB6266, HZ018758, HZ018181, 05CILB5410, HZ017615, HZ017067, HZ016612, HZ015958, HZ015553, HZ015417, HZ014730, HZ014327, HZ014171, HZ013700, HZ013169, HZ013001, HZ012487, HZ011487, HZ011261, HP132094, HZ010325, HZ009494, 05CILB0589, HZ008563, HZ008239, HZ008058, HZ007530, 05CILA9418, 05CILA9229, HP129912, HP129685, HP129429, HP129315, HP129164, HP129058, HP128972, HP128810, HP128675, HP128399, HP128224, HP128105, HP127874, HP127749, HP127629, HP127335, HP127192, HP126977, HP12686
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank of Chicago, Chicago, IL, by facsimile transmissions dated August 9, 2006 and August 22, 2006. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor with a history of having tested positive for Hepatitis B, was distributed.
VOLUME OF PRODUCT IN COMMERCE
74 units
DISTRIBUTION
CA, Austria, and Germany

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0379-07
CODE
Units: 0272734, 0274726, 0235248, 0244250, 0267730, 0268749, and 0264369
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on July 19, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MS

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PRODUCT
Red Blood Cells Irradiated, Recall # B-0382-7
CODE
Unit: 0341727
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on February 21, 2006. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

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PRODUCT
Red Blood Cells, Recall # B-0383-7
CODE
Unit: 0312982
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on March 30, 2006. Firm initiated recall is complete.
REASON
Blood product, which tested initially reactive for the hepatitis B surface antigen (HBsAg), but was not subsequently retested in duplicate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

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PRODUCT
Red Blood Cells, Recall # B-0384-07
CODE
Unit: 0203452
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on November 23, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which a corresponding blood product contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

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PRODUCT
Fresh Frozen Plasma, Recall # B-0385-7
CODE
Units: 9962690 and 9960828
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on March 16 and 17, 2004. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from whole blood units in which collection extended beyond the allowable time limits, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA

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PRODUCT
Platelets, Recall # B-0388-7
CODE
Units: 0204724, 0231729, 0200733, 0200735, 023280, 022470, 022471, 0232378, 0232379, 0230887, 0230889, and 0230894
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on February 9, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have been stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
LA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0434-07
CODE
Units: 177359570, 177359054, 177359029
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. Mcallen, TX, by telephone on May 17, 2005. Firm initiated recall is complete.
REASON
Red Cells, lacking assurance of proper storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX
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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0445-7
CODE
Unit: 22FQ36985
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter dated June 29, 2006, Firm initiated recall is complete.
REASON
Red Cells, mislabeled for the ‘C’ antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
VerifyNow P2Y12 Assay Device Kit, Part Number 85054, Recall # Z-0228-2007
CODE
Lot Numbers: WK0002A, WK0003A, WK0003B, WK0004A, WK0005A, WK0006A, WK0006AR, WK0006B, WK0006BR, WK0007A, WK0008A, WK0009A, WK0010A, WK0010B, WK0010C, WK0011A, WK0012A, & WK0013A
RECALLING FIRM/MANUFACTURER
Accumetrics, Inc., San Diego, CA, by letter or e-mail on September 5, 2006 – September 13, 2006. Firm initiated recall is ongoing.
REASON
The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.
VOLUME OF PRODUCT IN COMMERCE
333 devices
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
BioMerieux BacT/Alert SN Anaerobic Culture Bottle-REF 259790, Recall # Z-0243-2007
CODE
Lot number: 1013177
RECALLING FIRM/MANUFACTURER
BioMerieux, Inc., Durham, NC, by a field corrective action notification August 28, 2006. Firm initiated recall is ongoing.
REASON
Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer detection times.
VOLUME OF PRODUCT IN COMMERCE
34,400 bottles
DISTRIBUTION
Nationwide

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PRODUCT
Neoprene Pecan Shaped Breathing Bag. Bag with 15 mm neck insert, size 1 liter, a rebreathing bag. Made in UK, Catalog Number (REF) 21176AP, Recall # Z-0244-2007
CODE
Lot number: 070318-1
RECALLING FIRM/MANUFACTURER:
Recalling Firm: Teleflex Medical, Bannockburn, IL, by letters dated October 31, 2006.
Rusch Manufacturing (U.K.), Teleflex Medical, Armagh, N. Ireland. Firm initiated recall is ongoing.
REASON
Mislabeling-The rebreathing bag is incorrectly labeled as a 1 liter. The rebreathing bag is actually a ½ liter bag.
VOLUME OF PRODUCT IN COMMERCE
50 bags
DISTRIBUTION
Nationwide

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PRODUCT
Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model Number: 99120-01, Recall # Z-0246-2007
CODE
Lot numbers: 3098, 3099, 3100
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA. by letter on September 18, 2006. Firm initiated recall is ongoing.
REASON
Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results.
VOLUME OF PRODUCT IN COMMERCE
4,708 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D, Recall # Z-0247-2007
CODE
Lot Numbers: 20071127, 20071128
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., West Sacramento, CA., by telephone and letters on September 27, 2006. Firm initiated recall is ongoing.
REASON
Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.
VOLUME OF PRODUCT IN COMMERCE
828 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
a) Sling Rope/Connector Assembly Kits for the Sara and Sara Nova
standing and raising aids; the kit is comprised of 2 x 200 cm ropes,
2 knobs, 2 sling connectors, 2 socket cap screws, 2 nylon nuts and
2 spacers; Arjo Inc., 50 N. Gary Avenue, Roselle, IL 60172;
Model KS1006, Recall # Z-0248-2007;
b) Sling Rope/Connector Assembly Kits for the Sara Power standing
and raising aids; the kit is comprised of 2 x 230 cm ropes, 2 knobs,
2 sling connectors, 2 socket cap screws, 2 nylon nuts and 2 spacers;
Model KS1019, Recall # Z-0249-2007
CODE
All kits shipped between July 2006 through September 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, by letters on October 30, 2006.
Manufacturer: Medibo, N.V., Hanmont, Achel, Belgium. Firm initiated recall is ongoing.
REASON
The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose.
VOLUME OF PRODUCT IN COMMERCE
25 rope lots
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

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PRODUCT
VITROS® Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS® Chemistry Systems typically used in hospital laboratories. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08, Recall # Z-0245-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester NY, by letters on October 9, 2006. Firm initiated recall is ongoing.
REASON
The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS® LIPA slides if they have been stored on the VITROS® Chemistry Systems for more than 2 days.
VOLUME OF PRODUCT IN COMMERCE
10.777 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR December 13, 2006

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