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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November 3, 2004
04-44

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

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PRODUCT
Almonds, whole or diced, raw. Product packaged in boxes containing Bassett Nut Company, Holland, OH label. Package sizes vary from 4 lb.-50 lb. boxes depending on customer order. Recall # F-068-5.
CODE
No code on boxes. Purchase date between October, 2003 and April, 2004.
RECALLING FIRM/MANUFACTURER
JML Holdings Inc, Holland, OH, by facsimile and letter on July 2, 2004. Firm initiated recall is ongoing.
REASON
The product was manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
Approximately 198.75 lbs.
DISTRIBUTION
OH and MI.

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PRODUCT
a) Garden Fresh Brand Alfalfa Sprouts, raw in 4 oz plastic bag.
Recall # F-069-5;
b) Garden Fresh Brand Salad Sprouts, Alfalfa and/or Clover
Sprouts, raw in 1 lb. plastic bags. Recall # F-070-5.
CODE
No code information is printed on the containers. All product produced prior to 06/04/04 is included in the recall.
RECALLING FIRM/MANUFACTURER
Sun Sen Salad Co Inc, Sacramento, CA, by telephone on June 4, 2004 and Press Release. Firm initiated recall is complete.
REASON
These sprouts were manufactured using alfalfa seed lot X3023 that was recalled by Caudill Seed & Warehouse, Inc. because of its association with an outbreak of Salmonella Bovismorbificans illness.
VOLUME OF PRODUCT IN COMMERCE
900 lbs.
DISTRIBUTION
CA and NV.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
ADVAIR DISKUS® Inhalation Powder, (fluticasone
propionate/salmeterol inhalation powder), 100/50mcg, one Diskus
Inhalation Device containing 1 Foil Strip of 60 blisters, For
Oral Inhalation Only, Rx only, NDC 0173-0695-00. Recall # D-
049-5.
CODE
Lot Numbers: 4ZP2067, 4ZP2104, 4ZP2201, 4ZP2216, 4ZP2217, 4ZP2229, 4ZP2377, 4ZP2474, 4ZP2475, 4ZP2619, 4ZP2759, 4ZP2807, 4ZP2913, 4ZP2901, 4ZP3041, 4ZP3042, 4ZP3139, 4ZP3244, 4ZP3272, 4ZP3373, 4ZP3444, 4ZP3504, 4ZP3550, 4ZP3631, 4ZP3659, Expiration dates: Ranging between May 2005 and July 2005.
RECALLING FIRM/MANUFACTURER
GlaxoSmithKline Inc, Zebulon, NC, by letters on October 15, 2004. Firm initiated recall is ongoing.
REASON
Defective container; patients may not receive medication as it is advanced through the Diskus unit.
VOLUME OF PRODUCT IN COMMERCE
409,382 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-0107-5.
CODE
Units 71W178307.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile dated August 25, 2003.
Manufacturer: LifeSouth Community Blood Centers, Civitan Regional Blood, Montgomery, AL. Firm initiated recall is complete.
REASON
Platelets, that were below specification for platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units-split.
DISTRIBUTION
AL.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0111-5.
CODE
Unit 12813-6293.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, New Mexico, by facsimile transmission dated August 19, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ and Switzerland.

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PRODUCT
Human Corneal Tissue for Transplantation. Recall # B-0113-5.
CODE
Tissues 04-1238-100 and 04-1238-200.
RECALLING FIRM/MANUFACTURER
Rocky Mountain Lions Eye Bank, Aurora, Colorado, by letters dated September 29, 2004. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeated reactive for the Hepatitis B Surface Antigen (HBsAg) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
CO, and Ireland.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0117-5.
CODE
Units 71W326702- split 1 and split 2.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on July 16, 2003.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc., Montgomery Region, Montgomery, AL. Firm initiated recall is complete.
REASON
Blood products, which yielded a platelet count that was below the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL.

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PRODUCT
Human Tissue for Transplantation of the following types:
Corneas,
a) Various musculoskeletal tissues;
b) Skin. Recall # B-0121-5.
CODE
Numbers SL01-11-017R1 and SL01-11-017L1;
a) and b) Donor number 11001709.
RECALLING FIRM/MANUFACTURER
Mid-American Transplant Service, Olivette, MS, by electronic mail on February 28, 2002, and by letter on March 11, 2002. Follow-up notifications were sent to one consignee by facsimile, mail, and telephone. Firm initiated recall is complete.
REASON
Human tissue for transplantation was incorrectly tested for viral markers in that the blood sample used for testing was likely hemodiluted.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
CO, NJ, and Mexico.

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PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0133-5.
CODE
Units 71M587987, 71M580384, and 71M580360.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Inc., Huntsville, AL, by telephone on June 24, 2004. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from overweight whole blood units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AL.

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PRODUCT
Fresh Frozen Plasma. Recall # B-0134-5.
CODE
Unit 71J08471.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Inc., Huntsville, AL, by facsimile on February 20, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was at risk for Creuztfeldt Jakob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

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PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0136-5;
b) Platelets, Recall # B-0137-5.
CODE
a) and b) Unit 127924587.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, NM, by letter dated February 12, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had lived in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
New Mexico.

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PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0138-5;
b) Red Blood Cells Leukocytes Reduced Irradiated.
Recall # B-0139-5.
CODE
Units 128003536 and 127966397;
Unit 127992878.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, NM, by telephone on December 26, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX and CO.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS ‚ CLASS III

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PRODUCT
a) Red Blood Cells, Irradiated. Recall # B-0108-5;
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-0109-5;
c) Platelets Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-0110-5.
CODE
a) Unit 71L00739;
b) Unit 71L231174;
c) Unit 71W14396X.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, Fl, by facsimile transmission dated May 25, 2004.
Manufacturer: LifeSouth Community Blood Centers, Inc., Birminham, AL. Firm initiated recall is complete.
REASON
Blood products, that lacked assurance of proper storage temperatures due to inaccurate documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AL.

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PRODUCT
Recovered Plasma. Recall # B-0112-5.
CODE
Unit 12813-6293.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, New Mexico, by facsimile transmission dated August 19, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ and Switzerland.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0122-5.
CODE
Unit number 71H689903.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on May 27, 2003.
Manufacturer: LifeSouth Community Blood Centers, North Alabama Region - Huntsville, Huntsville, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not properly determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0135-5.
CODE
Unit 71L336433.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Inc., Huntsville, AL, by facsimile on February 3, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable hematocrit specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

CORRECTION

The Enforcement Report of October 27, 2004 which reported the Becton Dickinson recall of DifcoBBL Gram Crystal Violet, Recall # Z-0025-05 has been corrected to delete reference to Gram Stain Kits and Reagents, as no kits were involved in the recall.

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PRODUCT
a) AXIOM Sensis Programmable diagnostic computer, Model number
66 23 974. Recall # Z-0032-05.
b) AXIOM Sensis Programmable diagnostic comp uter, Model number
66 34 633. Recall # Z-0033-05;
c) AXIOM Sensis Programmable diagnostic computer, Model number
66 34 641. Recall # Z-0034-05;
d) AXIOM Sensis Programmable diagnostic computer, Model number
66 34 658. Recall # Z-0035-05;
e) AXIOM Sensis Programmable diagnostic computer, Model number
66 48 161. Recall # Z-0036-05.
CODE
a) Serial numbers: 1155, 6002, 6006-6014, 6016, 6018-6021,
6023-6025, 6027-6053, and 6100-6125. Model number 66 34 641
involves the following serial numbers: 4001-4008 and 4050-
4056. Model number 66 34 658 involves the following serial
numbers: 8001-8003, 8006-8007, 8009-8010, and 8050-8055.
Model number 66 48 161 involves the following serial numbers:
11001-11014, 11016, 11018, and 11050-11054;
b) Serial numbers: 2001-2011, 2013-2023, 2025-2026, 2028,
2031-2067, 2069-2090, 2092-2132, 2134-2143, 2145-2148,
2150-2158, 2160-2260, 2262, and 2265-2266;
c) Serial numbers: 4001-4008 and 4050-4056;
d) Serial numbers: 8001-8003, 8006-8007, 8009-8010, and
8050-8055.
e) Serial numbers: 11001-11014, 11016, 11018, and 11050-11054.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letter, on July 9, 2004. Firm initiated recall is ongoing.
REASON
Possible error calculating valve area with the AXIOM Sensis.
VOLUME OF PRODUCT IN COMMERCE
143 units.
DISTRIBUTION
Nationwide.

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PRODUCT
NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V. Recall # Z-0037-05.
CODE
Lot 2007-06 HP.
RECALLING FIRM/MANUFACTURER
3 M Company/Medical Division, South St Paul, MN, by letter dated September 30, 2004. Firm initiated recall is ongoing.
REASON
Improper wire placement from the patient plate to the ESU connector plug results in an intermittent displacement connection.
VOLUME OF PRODUCT IN COMMERCE
15,360 pads.
DISTRIBUTION
Nationwide.

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PRODUCT
V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Recall # Z-0038-05.
CODE
Part M6275043-5: 01.27.04.21v; 01.27.04.22v; 01.27.04.23v; 02.23.04.03; 05.06.04.07; 05.17.04.01; 05.20.04.08; 06.23.04.12; 07.07.04.13; and 08.11.04.04 Part M6275065-5: 11.06.03.01V; 11.06.03.02V; 11.06.03.03V; 11.21.03.15; 12.01.03.25; 12.15.03.14; 12.18.03.07; 01.16.04.09; 01.08.04.10; 01.20.04.10; 12.15.03.14; 02.04.04.23; 01.21.04.24; 02.09.04.22; 02.23.04.07; 03.30.04.13; 03.22.04.10; 05.04.04.08; 05.14.04.04; 05.26.04.09; 06.02.04.07; 06.04.04.15; 06.17.04.12; 07.07.04.11; 07.07.04.12; 07.20.04.14; 07.30.04.03; and 08.03.04.06.
RECALLING FIRM/MANUFACTURER
Kinetic Concepts, Inc., San Antonio, TX, by letter and telephone on September 21, 2004. Firm initiated recall is ongoing.
REASON
The seal on the pouch may open during shipping and sterility may be compromised.
VOLUME OF PRODUCT IN COMMERCE
29,610 units.
DISTRIBUTION
Nationwide, and Internationally.

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PRODUCT
Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT. Recall # Z-0039-05.
CODE
Lot number 45535 exp 9/2008.
RECALLING FIRM/MANUFACTURER
Medrad Inc., Indianola, PA, by telephone on October 8, 2004. Firm initiated recall is ongoing.
REASON
Sterility can be compromised by a component tearing the outer packaging.
VOLUME OF PRODUCT IN COMMERCE
1.650 kits.
DISTRIBUTION
Nationwide.

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PRODUCT
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays. Recall # Z-0040-05.
CODE
Serial Numbers: ATO-001 through ATO-0082.
RECALLING FIRM/MANUFACTURER
Zimmer Spine, Inc., Minneapolis, MN, by letter, and telephone on August 24, 2004. Firm initiated recall is ongoing.
REASON
To date, there has been one complaint reported. During a Trinica surgical case, the surgeon was provided a standard disposable, Trinica Drill Bit (part number 07.00166.001) for use with the Trinica All Through One Drill Guide Instrumentation, instead of the ALL Through One Drill Bit. This enabled the physician to drill a few millimeters further than expected.
VOLUME OF PRODUCT IN COMMERCE
82 sets.
DISTRIBUTION
Nationwide.

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PRODUCT
Ultra Power Burs, Sterile, Single-Use. Recall # Z-0041-05.
CODE
All product with an expiration date between August 2004 and August 2009.
RECALLING FIRM/MANUFACTURER
Linvatec Corp, Largo, FL, by telephone, email, and letter on August 26, 2004. Firm initiated recall is ongoing.
REASON
The pouch containing the sterile product is not completely sealed on all products. Therefore, the sterility of the device is questionable.
VOLUME OF PRODUCT IN COMMERCE
58,510 Bars.
DISTRIBUTION
Nationwide and Internationally.

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PRODUCT
DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies. Recall # Z-0042-05.
CODE
Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685, 57755, 57819, 57820, and 57832.
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE, by letter dated August 27, 2004. Firm initiated recall is ongoing.
REASON
APTT determinations when using affected rotors may lead to incorrectly shortened times.
VOLUME OF PRODUCT IN COMMERCE
7,140 units.
DISTRIBUTION
Nationwide.

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PRODUCT
The MDA system with MDA Antithrombin III MDA Heparin. Recall # Z-0043-05.
CODE
All product numbers.
RECALLING FIRM/MANUFACTURER
BioMerieux, Durham, NC, by letter on June 11, 2004 and July 9, 2004. Firm initiated recall is ongoing.
REASON
The firm received complaints regarding an observed bias in percent activity between capped and uncapped speciments.
VOLUME OF PRODUCT IN COMMERCE
588 units.
DISTRIBUTION
Nationwide and Internationally.

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PRODUCT
a) Advanced Bionics implantable cochlear stimulator
CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R
(For Export Only) AB-5100H AB-5100H-01A. Recall
# Z-0044-05;
b) Advanced Bionics implantable cochlear stimulator
CLARION CII Models AB-5100H-11A AB-5100h-12A. Recall
# Z-0045-05;
c) Advanced Bionics implantable cochlear stimulator
HiRes 90, Models CI-1400-01 CI-1400-02. Recall # Z-0046-05.
CODE
a) Unimplanted CLARION 1.2;
b) Unimplanted CLARION CII;
c) HiRes 90K Implantable Cochlear Stimulator, Model
Number CI-1400-01, manufactured prior to December 1, 2003.
RECALLING FIRM/MANUFACTURER
Advanced Bionics, Sylmar, CA, by telephone and letter on September 27, 2004. Firm initiated recall is ongoing.
REASON
All unimplanted CLARION and HiResolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.
VOLUME OF PRODUCT IN COMMERCE
42 units.
DISTRIBUTION
Nationwide, Canada and France.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Hem-o-lok® Endo5™ Ligation Applier. Recall # Z-0031-05.
CODE
Catalog number 544965, Lot 943704, 943705, 954592.
RECALLING FIRM/MANUFACTURER
Weck, Research Triangle Park, NC, by letter and email on August 18, 2004. Firm initiated recall is ongoing.
REASON
The jaws may break during clip loading or clip application.
VOLUME OF PRODUCT IN COMMERCE
119 units.
DISTRIBUTION
Nationwide and Internationally.

END OF ENFORCEMENT REPORT FOR November 3, 2004

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