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U.S. Department of Health and Human Services

Safety

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Enforcement Report for April 20, 2005

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.

April 20, 2005
05-16

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

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PRODUCT
“Fresh Batch” Snickerdoodle Cookies; a cinnamon flavored sugar cookie; packaged in 13.5 oz. plastic clamshells, 12 packages per case. UPC 0 2169801875 7. Recall # F-266-5.
CODE
All date codes.
RECALLING FIRM/MANUFACTURER
Parco Foods, L.L.C., Blue Island, IL, by press release and telephone on March 16, 2005. Firm initiated recall is ongoing.
REASON
The cookies were manufactured with eggs, which were not included on the ingredients statement of the label.
VOLUME OF PRODUCT IN COMMERCE
2,539 cases.
DISTRIBUTION
DC, FL, GA, KY, MD, NC, PA, SC, TN, VA, and WV.   

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PRODUCT
Tuna Salad prepared in 5 lb bulk and 8 oz. containers, packaged under the following labels: Shaw’s Deluxe Tuna, 5 lbs; Stop & Shop Deluxe Tuna Salad, 5 lbs; Block & Farrel Deluxe Tuna Salad, 5 lbs; Shaw’s Homestyle Tuna Salad, 8 oz. Recall # F-267-5.
CODE
Sell By Date codes between March 15, and March 31, 2005.
RECALLING FIRM/MANUFACTURER
Hans Kissle Co., Inc., Haverhill, MA, by telephone, press release and letter on March 14, 2005. Firm initiated recall is ongoing.
REASON
Product may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE 
572 (1x5 lb); 1670 (2x5 lb cases); 129 cases/8.
DISTRIBUTION 
MA, RI, NH, VT, NY, and NJ.

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PRODUCT
a) FORTUNER’S Selected Food brand DRIED HONEYSUCKLE, N.W. 4ozs(113g), MADE IN CHINA, Product of China. Serving size 1 cup, Servings per Carton 10. The product is packaged in a red & clear colored flexible plastic bag with red, green, black, & white lettering, and a yellow adhesive sticker identifying the product name & weight. The product is visible through the packaging and appears as dried flower petals. Barcode 7 986988 932379. Recall # F-268-5;
b) BiFeng® brand DRIED POTATO, NET WT: 7 OZ. PRODUCT OF CHINA. The product is packaged in a clear flexible plastic bag with gold, red, black & white lettering, and a white adhesive sticker identifying the product name & weight. Barcode 6 92404375259. Recall # F-269-5.
CODE
a) Barcode and no other coding;
b) Expiration date “20050716” found on the back lower right hand corner of the package.
RECALLING FIRM/MANUFACTURER
Great Kingsland, Inc., Brooklyn, NY, by press release and letter issued on February 18, 2005. Firm initiated recall is ongoing.
REASON
The product contains undeclared sulfites based on FDA’s sampling & analysis.
VOLUME OF PRODUCT IN COMMERCE 
a) 5 cases (100-4 oz. packages per case);
b) 132 cases (35-7 oz. packages per case).
DISTRIBUTION 
NY, IL, MA, NJ, and MD.

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PRODUCT
Van de Kamp’s Cinammon Rolls, 12 oz. package of 3 rolls. UPC 41175 77270. Recall # F-270-5.
CODE 
All pull dates prior to 3/17/05.
RECALLING FIRM/MANUFACTURER
Little Brothers Bakery LLC, Gardena, CA, by product removal on March 9, 2005, and by press release on March 14, 2005. Firm initiated recall is ongoing.
REASON
Product contains undeclared whey.
VOLUME OF PRODUCT IN COMMERCE
539 units.
DISTRIBUTION 
CA.

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PRODUCT
ADAR brand Pre Sliced Smoked Salmon, net wt. 8 oz. Product of Canada. Ingredients: Steelhead Salmon, salt, natural spices, natural hard wood smoke. The product was packed in clear cellophane plastic packaging, 24 – 8 oz. packages per case. Barcode #0 62451 00112 8. Recall # F-271-5.
CODE
Barcode only.
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Adar USA Inc., Brooklyn, NY, by visit on January 12, 2005. Manufacturer: National Herring Importing Co., Anjou, Quebec, Canada. Firm initiated recall is complete.
REASON 
The product was contaminated with Listeria monocytogenes, a pathogenic organism, based on FDA’s analysis.
VOLUME OF PRODUCT IN COMMERCE 
12 cases (24 – 8 oz. packages per case).
DISTRIBUTION 
NY.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
SKY, Acetaminophen, NDC 63739-002-01, 325 mg tablets, Pain Reliever/Fever Reducer, UD 750 Tablets (25X30), For Institutional Use Only. a) Unit Dose: 1500 tablets (25 sheets per box x 30 individual doses per sheet x 2 tablets per blister pack), NDC 6373900211* b) UD 750 (25 sheets per box x 30 individual doses per sheet), NDC 6373900201* c) Punch Card 1500 (25 sheets per box x 30 individual doses per sheet x 2 tablets per blister pack), NDC 6373900213. Recall # D-187-5.
CODE 
a) Lot #0017359;
b) Lot #0017358;
c) Lot #0017359.
RECALLING FIRM/MANUFACTURER 
Recalling Firm: McKesson Packaging Services, Concord, NC, by letter on/about March 15, 2005.
Manufacturer: MAGNO-HUMPHRIES, Laboratories, Incorporated, Tigard, OR. Firm initiated recall is ongoing.
REASON
The product may contain metal particles.
VOLUME OF PRODUCT IN COMMERCE 
4,755 boxes.
DISTRIBUTION 
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
Propoxyphene Napsylate and Acetaminophen Tablets USP, 100 mg/650 mg, PINK, CIV, 1000 tablet bottles, Rx only, Firm on label: Mallinckrodt Inc., St. Louis, Missouri ** Tyco Healthcare, NDC 0406-1772-10. Recall # D-186-5.
CODE 
1721J02641, Exp. 12/2006.
RECALLING FIRM 
Mallinckrodt, Inc., Berkeley, MO, by telephone on/about March 11, 2005 and by letters on March 18, 2005. Firm initiated recall is ongoing.
REASON 
Labeling: Bottle label identifies pink tablets but bottle actually contains white tablets.
VOLUME OF PRODUCT IN COMMERCE 
1,194 bottles x 1000 tablets.
DISTRIBUTION 
Nationwide.

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PRODUCT
a) Premarin (conjugated estrogens tablets USP), 0.625 mg, 1,000 tablet bottles, Rx, NDC 0046-0867-91. Firm on label: Wyeth Pharmaceuticals Inc., Philadelphia, PA. Recall # D-188-5;
b) Premarin (conjugated estrogens tablets USP), 0.3 mg, 1,000 tablet bottles, Rx, NDC 0046-0868-91. Recall # D-189-5.
CODE 
a) A45580, Exp. 10/2005;
b) A32677, Exp. 07/2005.
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Richmond Division of Wyeth, Richmond, VA, by letters dated April 4, 2005. Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY. Firm initiated recall is ongoing.
REASON 
Dissolution failures.
VOLUME OF PRODUCT IN COMMERCE 
0.625 mg – 16,737 bottles;
0.3 mg – 11,990 bottles.
DISTRIBUTION 
Nationwide.

RECALLS AND FIELD CORRECTIONS: Biologics - CLASS II

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0920-5.
CODE
Units 6025228, 6025579, 6025227, 6025097, 6025352, 6025374, 8516466, 6025012, 6025017, 6025288, 6025541, 6025572, 6024976, 8516454, 8516566, 8516582, 6025075, 6025310, 6025048, 6025077, 6025286, 6025320, 6025429, 6025510, 6025564, 6025571, 8516567, 6025243, 6025244, 8516588, 8516551, 6025194, 6025203, 6025255, 6025258, 8516457, 6025550, 6025069, 6025062, 6025092, 6025100, 6025122, 6025123, 6025139, 6025328, 6025329, 8516439, 8516479, 8516504, 6025267, 6025305, 6025422, 6025458, 6025467, 6025129, 6025412, 8516587, 6024926, 6024931, 6024978, 6025039, 6025185, 6025189, 6025191, 6025200, 6025301, 6025418, 6025439, 6025155, 6025434, 6025474, 6024940, 6025018, 6024991, 6025050, 6024939, 6024949, 6025021, 6025058, 6025080, 6025084, 8516420, 8516437, 8516458, 6025379, 6025442, 6025456, 6025459, 6025463, 6025472, 8516536, 8516590, 8516422, 6024951, 6025049, 6025061, 6025160, 6025343, 6025414, 6025516, 6025078, 6025152, 8516424, 6025237, 6024986, 6025000, 6025010, 6025195, 6025256, 8516468, 6025261, 6025268, 6025287, 6025308, 6025332, 6025403, 6025421, 6025465, 6025475, 6025495, 6025534, 6025120, 6025283, 6024958, 6025197, 6025483, 8516417, 8516452, 6025391, 8516515, 8516517, 8516548, 8516598, 6025527, 6025088, 6025112, 6025008, 6025016, 8516499, 6025358, 6024927, 6025154, 6025007, 6025023, 6025158, 6025368, 6025213, 6025105, 6025124, 6025135, 6025151, 8516425, 8516456, 6025264, 6024944, 6024953, 6024977, 6025253, 8516474, 6025270, 6025415, 6025419, 6024946, 8516405, 6025231, 6025171, 6024950, 6025545, 6025114, 6015205, 6025216, 6025246, 6025460, 6024992, 6025103, 6025146, 6025148, 6025453, 6025461, 6025314, 6025386, 6025404, 6025489, and 6025509.
RECALLING FIRM/MANUFACTURER 
Blood Bank of Delmarva, Inc., Newark, DE, by letter dated October 15, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors with unacceptable hemoglobin determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
184 units.
DISTRIBUTION 
DE, and MD.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0933-5.
CODE
Unit 12Q68077.
RECALLING FIRM/MANUFACTURER 
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on February 17, 2004. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit.
DISTRIBUTION 
NC.

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PRODUCT
Cryoprecipitated AHF. Recall # B-0934-5.
CODE 
Unit 12FX79622.
RECALLING FIRM 
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on February 18, 2004. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit.
DISTRIBUTION 
NC.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0939-5;
b) Platelets, Leukocytes Reduced. Recall # B-0940-5.
CODE 
a) Units 19LM13863, 19LQ29403;
b) Unit 19LM13863.
RECALLING FIRM/MANUFACTURER 
American National Red Cross, Tennessee Valley Region, Nashville, TN, by telephone on October 31, 2001 and by letter dated November 6, 2001. Firm initiated recall is complete.
REASON 
Blood products, manufactured from overweight units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
3 units.
DISTRIBUTION 
KY, and TN.

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PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0951-5,
CODE 
Unit 04R23619.
RECALLING FIRM/MANUFACTURER 
American Red Cross Blood Services, Dedham, MA, by facsimile on January 20, 2005. Firm initiated recall is complete.
REASON 
Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit.
DISTRIBUTION 
NY.

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PRODUCT
Platelets Leukocytes Removed. Recall # B-0952-5.
CODE 
Unit 19GR46019.
RECALLING FIRM/MANUFACTURER 
American National Red Cross, Tennessee Valley Region, Nashville, TN, by letter, dated February 3, 2003. Firm initiated recall is complete.
REASON 
Blood product, possibly contaminated with Bacillus sp., was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit.
DISTRIBUTION
TN.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0953-5.
CODE 
Unit 19GL52888.
RECALLING FIRM/MANUFACTURER 
American Red Cross, Tennessee Valley Region, Nashville, TN, by telephone on April 29, 2004. Firm initiated recall is complete.
REASON 
Platelet Pheresis, possibly contaminated with coagulase-negative, Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit.
DISTRIBUTION 
TN.

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PRODUCT
Red Blood Cells, Deglycerolized, Leukocytes Reduced. Recall # B-0954-5.
CODE
Unit number: 8463338.
RECALLING FIRM/MANUFACTURER 
LifeShare Blood Centers, Shreveport, LA, by letter, dated May 4, 2004. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the receipt of confirmed positive Hepatitis B Surface Antigen (HBsAg) test results, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit. 
DISTRIBUTION 

LA.

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PRODUCT
Source Plasma. Recall # B-0955-5.
CODE
Unit numbers: 00203180, 00225250, 00246453, and 00275514.
RECALLING FIRM/MANUFACTURER 
ZLB Bioplasma, Inc., Lansing, MI, by facsimile on July 1, 2004. Firm initiated recall is complete.
REASON 
Blood products, which were collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
4 units.
DISTRIBUTION 
CA.

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PRODUCT
Red Blood Cells. Recall # B-0956-5.
CODE
Unit 04GF41981.
RECALLING FIRM/MANUFACTURER 
American Red Cross Blood Services, Dedham, MA, by facsimile and telephone on November 16, 2004. Firm initiated recall is complete.
REASON 
Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit.
DISTRIBUTION 
NY.

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PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0957-5;
b) Recovered Plasma. Recall # B-0958-5.
CODE
a) and b) Unit 04KL74881.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Dedham, MA, by electronic mail, facsimile, or letter on December 15, 2004. Firm initiated recall is complete.
REASON 
Blood products, which were collected from a donor who provided a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units.
DISTRIBUTION 
NY and CA.

RECALLS AND FIELD CORRECTIONS: Biologics - CLASS III

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PRODUCT 
a) Red Blood Cells. Recall # B-0823-5;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0824-5;
c) Red Blood Cells, Washed. Recall # B-0825-5;
d) Red Blood Cells, Frozen. Recall # B-0826-5;
e) Platelets. Recall # B-0827-5;
f) Platelets Pheresis, Leukocytes Reduced. Recall # B-0828-5;
g) Cryoprecipitated AHF. Recall # B-0829-5;
h) Fresh Frozen Plasma. Recall # B-0830-5.
i) Plasma, Cryoprecipitate Reduced. Recall # B-0831-5.
CODE
Blood products, collected between May 2001 and April 2003, of the types listed above.
RECALLING FIRM/MANUFACTURER 
Mississippi Blood Services, Inc., Jackson, MS, by facsimile, e-mail, and telephone beginning September 30, 2003, and by letters dated September 30, 2003, February 16, 2004, and March 25, 2004. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for human immunodeficiency virus type 1 (HIV-1) antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
23,364 units
DISTRIBUTION 
Nationwide.

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PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-0922-5;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0923-5.
CODE
a) and b) Unit 12W86533.
RECALLING FIRM/MANUFACTURER 
American Red Cross Blood Services, Charlotte, NC, by telephone on February 17, 2004. Firm initiated recall is complete.
REASON 
Blood product, which was collected from a donor in which a satisfactory arm inspection was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units.
DISTRIBUTION 
NC.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0941-5.
CODE
Unit number: 04GH12559 (Part 1).
RECALLING FIRM/MANUFACTURER 
American Red Cross, New England Region, Dedham, MA, by telephone and by letter, dated January 19, 2005. Firm initiated recall is complete.
REASON 
Platelets Pheresis, possibly contaminated with bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit.
DISTRIBUTION 
MA.

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0944-5.
CODE
Unit number: 04LP61765 (Parts A, B, and C).
RECALLING FIRM/MANUFACTURER 
American Red Cross, New England Region, Dedham, MA, by telephone and by letter, dated January 18, 2005. Firm initiated recall is complete.
REASON 
Platelet Pheresis, possibly contaminated with bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
3 units.
DISTRIBUTION 
MA.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0961-5
CODE
Units 19FZ06300, 19LM18507, 19LQ35595, 19GF44527, 19GK69445, 19GH47875, 19GC15959, 19GN04800.
RECALLING FIRM/MANUFACTURER 
American National Red Cross, Tennessee Valley Region, Nashville, TN, by letter dated February 3, 2003. Firm initiated recall is complete.
REASON 
Blood products, manufactured from units of whole blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
8 units.
DISTRIBUTION
TN.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
a) ENTrak Navigation and Visualization System. The particular accessories (“Sensors”) involved are:

  • Short Range Transmitter;
  • Snap Receiver Cable;
  • Extended Range Transmitter;
  • and T-Handle Spine Tool Receiver.

Recall # Z-0687-05;

b) ENTrak Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are:

  • Short Range Transmitter;
  • Snap Receiver Cable;
  • Extended Range Transmitter;
  • and T-Handle Spine Tool Receiver.

Recall # Z-0688-05;

c) Insta Trak 3000 Navigation and Visualization System. The particular accessories (“Sensors”) involved are:

  • Short Range Transmitter;
  • Snap Receiver Cable;
  • Extended Range Transmitter;
  • and T-Handle Spine Tool Receiver.

Recall # Z-0689-05;

d) Insta Trak 3500 Navigation and Visualization System. The particular accessories (“Sensors”) involved are:

1) Short Range Transmitter;

  • Snap Receiver Cable;
  • Extended Range Transmitter;
  • and T-Handle Spine Tool Receiver.

Recall # Z-0690-05;

e) Insta Trak 3500 Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are:

1) Short Range Transmitter;

  • Snap Receiver Cable;
  • Extended Range Transmitter;
  • and T-Handle Spine Tool Receiver.

Recall # Z-0691-05;

f) Fluro Trak 9800 Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are:

1) Short Range Transmitter;

  • Snap Receiver Cable;
  • Extended Range Transmitter;
  • and T-Handle Spine Tool Receiver.

Recall # Z-0690-05;
CODE
a), b), c), d), e) and f) 1) (P/N 1004587 or 1002008); 2) (P/N 1004069 or 1001989);

  • (P/N 1004070 or 1003991);
  • (P/N 1004072).

RECALLING FIRM/MANUFACTURER 
GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on December 13, 2004. Firm initiated recall is ongoing.
REASON
Enhanced sterility testing revealed the sterilization efficacy of accessories (“Sensors”) used with certain Navigation and Visualization systems may be compromised.
VOLUME OF PRODUCT IN COMMERCE 
502 units.
DISTRIBUTION 
Nationwide and Canada.

_______________________________

PRODUCT

a) Baxter Posiflow Access Device for IV Access; a single use, sterile device with Posiflow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL. Recall # Z-0693-05; b) Baxter Extension Sets with Posiflow Access Device for IV Access; a single use, sterile fluid pathway devices with Posiflow Positive Displacement Feature. Recall # Z-0694-05.
CODE 
a) Product code 2N9050; all lots without expiration dating; b) P roduct codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; all lots without expiration dating.
RECALLING FIRM
Recalling Firm: Baxter Healthcare Corp, Round Lake, IL, by letters dated January 20, 2005. Manufacturer: Baxter Healthcare Corp, Aibonito, PR. Firm initiated recall is ongoing.
REASON 
Product older than three years may not operate as intended.
VOLUME OF PRODUCT IN COMMERCE
1,585,542 units.
DISTRIBUTION 
Nationwide and Venezuela.

_______________________________

PRODUCT
Easy Access Image Management System with CL. Net. Recall # Z-0695-05.
CODE
Part Numbers: SW R9.2 for Easy Access Enterprise Edition (W2K); R9.2, R8.2 for Easy Access Enterprise (HPUX 11); Easy Access entry R8.2 and R9.2; R2.1 and R3.1 for Easy Access Modality. The firm utilizes site numbers instead of serial numbers. Site numbers include: 530649, 505274, 506461, 505267, 87076, 101168, 101378, 101590, 102520, 103216, 103220, 103224, 103513, 103767, 104599, 104653, 104679, 104751, 104849, 105106, 105374, 105419, 105517, 105592, 105765, 105826, 105931, 250195, 504436, 504984, 505001, 505025, 505065, 505070, 505183, 505390, 505427, 505506, 505609, 505674, 505778, 505829, 505897, 505973, 506046, 506259, 506330, 506367, 506413, 506453, 506454, 506472, 506699, 519629, 519703, 519977, 520441, 521847, 522273, 526142, 526150, 526153, 526186, 530629.
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letter on January 31, 2005.
Manufacturer: Philips Medical Systems, Netherlands. Firm initiated recall is ongoing.
REASON 
Failure to update correctly when re-transmitting an image from the modality.
VOLUME OF PRODUCT IN COMMERCE 
60 units.
DISTRIBUTION 
Nationwide.

_______________________________

PRODUCT
Automatic Cutting Needle Model: NAC-1820B, Size 18 GA x 20 CM, Single use: Ethylene Oxide sterilized. Recall # Z-0697-05.
CODE
Lot number 04351 and 043272.
RECALLING FIRM/MANUFACTURER
Remington Medical Inc., Alpharetta, GA, by letter on February 15, 2005. Firm initiated recall is ongoing.
REASON 
The stylet hub detaches from the stylet needle.
VOLUME OF PRODUCT IN COMMERCE 
1,737 units.
DISTRIBUTION 
Nationwide.

_______________________________

PRODUCT
a) ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew - Right Device: Flexible TI - Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI - Knot Quickload Units (2) * Disposable - Single Use Only * Sterile/EO * Rx Only. Recall # Z-0698-05; b) BCP-7A, Quick Silver Bipolar Coagulation Probe, For use w/dual Plug Bipolar Generators * Catheter Diameter: 7 FR. Catheter Length: 35 CM. Disposable – Single Use Only * Sterile/EO * Rx Only * Recall # Z-0699-05.
CODE
Product Order #ESD-5:
Lot #1519202, Vendor Exp. 05/2002 * Label Exp. 08/2006, Lot #1520620, Vendor Exp. 05/2002 * Label Exp. 08/2006, Lot #1521208, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1521209, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1521210, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1521211, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1537952, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1540901, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1540902, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1541688, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1542196, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1545823, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1546030, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1548352, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1550759, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1551793, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1553535, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1577921, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1577922, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1577923, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1581400, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1582964, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584872, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584573, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584928, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1585415, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1593074, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1595660, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595661, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595662, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595663, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1695664, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1695665, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595666, Vendor Exp. 09/2003 * Label Exp. 03/2007;
b) Product Order #BCP-7A:
Lot #1331630, Vendor Exp. Date 01/2005 * Label Exp. Date 02/2005.
RECALLING FIRM/MANUFACTURER 
Wilson-Cook Medical, Inc., Winston Salem, NC, by letter on April 1, 2005. Firm initiated recall is ongoing.
REASON
The expiration date listed on the product label is greater than the vendor recommended expiration date.
VOLUME OF PRODUCT IN COMMERCE
249 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________

PRODUCT
a) CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system. Recall # Z-0700-05;
b) CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system. Recall # Z-0701-05.
CODE 
All serial numbers.
RECALLING FIRM/MANUFACTURER 
Neoprobe Corp, Dublin, OH, by telephone and e-mail beginning on December 2, 2004. Firm initiated recall is ongoing.
REASON 
The probe’s faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures.
VOLUME OF PRODUCT IN COMMERCE 
83 devices.
DISTRIBUTION 
MA, CA, FL, MO, UK, Taiwan, Japan, Hong Kong, Turkey and Switzerland.

_______________________________

PRODUCT
Voyager RX Coronary Dilatation Catheter. Recall # Z-0707-05.
CODE 
Catalog numbers apply in this recall situation as follows: Balloon Diameter (mm) Balloon Length (mm) 8 12 15 20 25 30 1.50 N/A 1011391-12 1011391-15 N/A N/A N/A 2.00 1011392-08 1011392-12 1011392-15 1011392-20 1011392-25 1011392-30 2.25 1011393-08 1011393-12 1011393-15 1011393-20 1011393-25 1011393-30 2.50 1011394-08 1011394-12 1011394-15 1011394-20 1011394-25 1011394-30 2.75 1011395-08 1011395-12 1011395-15 1011395-20 1011395-25 1011395-30 3.00 1011396-08 1011396-12 1011396-15 1011396-20 1011396-25 1011396-30 3.25 1011397-08 1011397-12 1011397-15 1011397-20 1011397-25 1011397-30 3.50 1011398-08 1011398-12 1011398-15 1011398-20 1011398-25 1011398-30 Column at the left represents the diameter. The last two digits after the hyphen indicate the length. Lot Numbers The full list of lot numbers being recalled exceeds 1000. The scope of the recall involves all lots of the sizes given above that have lot numbers in the range: 40101XX through 41231XX, inclusive where XX can be any digits. For reference lot numbers are date coded: YMMDDLS Where Y=last digit of year manufactured, MM=month manufactured, DD=day manufactured, L=location manufactured, (5= Temecula CA, 3= Clonmel Ireland, S=sequence (1= first lot of day, 2= second lot of day). TO IDENTIFY A UNIQUE PRODUCT ONE NEEDS BOTH THE PART NUMBER AND LOT NUMBER (MULTIPLE PART NUMBERS ARE ASSIGNED THE SAME LOT NUMBER PER THE CONVENTION ABOVE.
RECALLING FIRM/MANUFACTURER 
Guidant Corporation Advanced Cardiovascular System, Temecula, CA, by letter on January 27, 2005. Firm initiated recall is ongoing.
REASON 
Leak at guide wire exit notch could introduce air into the artery.
VOLUME OF PRODUCT IN COMMERCE 
180,000 units.
DISTRIBUTION 
Nationwide and Internationally.

_______________________________

PRODUCT
Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and V-243 Epic+ Models V-196, V-236 and V-239 Epic Models V-197 and V-233 Atlas Model V-242 Epic HF Models V-337 and V-338 Epic+HF Models V-339 and V-350 Atlas+ HF Models V-340, V-341 and V-343. Recall # Z-0709-05.
CODE 
To numerous to include here.
RECALLING FIRM 
St. Jude Medical, Sylmar, CA, by visit beginning on March 10, 2005. Firm initiated recall is ongoing.
REASON 
Sensitivity of a magnetic switch was not being set correctly. This could result in delivery of an unneeded shock during surgery with use of electrocautery.
VOLUME OF PRODUCT IN COMMERCE 
1,488 units.
DISTRIBUTION 
Nationwide and Internationally.

_______________________________

PRODUCT
KION Anesthesia System. Recall # Z-0710-05.
CODE
Serial Number: 2034; 3416; 3417; 3418; 3419; 3420; 3027; 0501; 3394; 3395; 3396; 3433; 3444; 3445; 3446; 2355; 2356; 2033; 2035; 1838; 1839; 1840; 1841; 1842; 1873; 1874; 1875; 1876; 1877; 1899; 1900; 1902; 1903; 2132; 2032; 1723; 1724; 1725; 1726; 1727.
RECALLING FIRM/MANUFACTURER 
Maquet, Inc., Bridgewater, NJ, by internal task team, updates started on January 11, 2005. Firm initiated recall is ongoing.
REASON 
Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.
VOLUME OF PRODUCT IN COMMERCE 
40 systems.
DISTRIBUTION
Nationwide.

_______________________________

PRODUCT
Stealth Station Cranial Application v.4.5. Catalog Numbers: 960-201 and 9730888. Recall # Z-0711-05.
CODE
Software v.4.5.
RECALLING FIRM 
Medtronic Surgical Navigation Technologies, Inc., Louisville, CO, by letters dated January 28, 2005 and February 2, 2005. Firm initiated recall is complete.
REASON 
The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient. The user has the option to create and make visible supplemental contours of specific anatomy viewable during a surgical procedure. Activation of a new tip extension feature will move the location of these contours in such a manner that they no longer correlate to the intended anatomy. Potential consequences may include improper resection of the brain tissue.
VOLUME OF PRODUCT IN COMMERCE 
44 systems.
DISTRIBUTION 
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: Devices - CLASS III

_______________________________

PRODUCT
DiaSorin ETI-EA-G assay kit, Catalog No. 7570. Recall # Z-0658-05.
CODE
Lot # 113963C.
RECALLING FIRM/MANUFACTURER 
Diasorin Inc., Stillwater, MN, by telephone on November 1, 2004. Firm initiated recall is ongoing.
REASON
The kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the Pro Trac II Tacrolimus kit.
VOLUME OF PRODUCT IN COMMERCE 
46 kits.
DISTRIBUTION
FL, TX, and UT.

_______________________________

PRODUCT
IMx HAVAB Controls in Vitro Test. Recall # Z-0660-05.
CODE
Lot # 21059Q100 Expiration Date: May 20, 2005.
FIRM/MANUFACTURER
Abbott Health Products, Inc., Barceloneta, PR, by letter on February 25, 2005. Firm initiated recall is ongoing.
REASON
Abbott identified through investigational studies that IMxHAVAB Controls is generating Negative Control values outside the upper range specified in the IMxHAVAB Package Insert.
VOLUME OF PRODUCT IN COMMERCE 
373 kits.
DISTRIBUTION 
Nationwide and Internationally.

_______________________________

PRODUCT
DiaSorin programming software written for a specific automated microtiter plate instrument, Bio-Tek Elx800 reader for use with the ENA 6 Screen ELISA kit assay. Recall # Z-0672-05.
CODE
Software versions 9 thru 12.
RECALLING FIRM/MANUFACTURER 
Diasorin, Inc., Stillwater, MN, by letter on April 20, 2004. Firm initiated recall is ongoing.
REASON 
An error in the Bio-Tek Elx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.
VOLUME OF PRODUCT IN COMMERCE 
16.
DISTRIBUTION 
CT, FL, NY, WA, TX, AR, TN, and Canada.

______________________________

PRODUCT
Data reduction program written specifically for Bio-Tek Elx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit. Recall # Z-0673-05.
CODE 
Software version 12.
RECALLING FIRM 
Diasorin, Inc., Stillwater, MN, by letter on April 12, 2004. Firm initiated recall is ongoing.
REASON
The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.
VOLUME OF PRODUCT IN COMMERCE 
8.
DISTRIBUTION 
CA, CT, KS, MA, and WA.

_______________________________

PRODUCT
Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit. Recall # Z-0674-05.
CODE 
Software version 12.
RECALLING FIRM/MANUFACTURER 
Diasorin, Inc., Stillwater, MN, by letter on October 26, 2004. Firm initiated recall is ongoing.
REASON 
The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.
VOLUME OF PRODUCT IN COMMERCE 
7.
DISTRIBUTION 
CT, MI, MT, UT, and Canada.

_______________________________

PRODUCT
Data reduction program software written specifically for Bio-Tek Elx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700). Recall # Z-0675-05.
CODE 
Software version 9 thru 12.
RECALLING FIRM/MANUFACTURER 
Diasorin, Inc., Stillwater, MN, by letter on April 12, 2004. Firm initiated recall is ongoing.
REASON 
The data reduction program written for a specific automated microtiter plate reader (Bio-Tek Elx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay. The negative Control Upper Limit should be less than 0.95, rather than less than 1.0.
VOLUME OF PRODUCT IN COMMERCE 
6.
DISTRIBUTION
CA, FL, MA, NY, and TX.

_______________________________

PRODUCT
PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluorescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604. Recall # Z-0676-05.
CODE 
PolyTiter software version 2.8.
RECALLING FIRM/MANUFACTURER 
Diasorin, Inc., Stillwater, MN, by telephone and letter on June 30, 2004. Firm initiated recall is ongoing.
REASON 
The program is for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160.
VOLUME OF PRODUCT IN COMMERCE 
14.
DISTRIBUTION 
Nationwide.

_______________________________

PRODUCT
a) Fill Tube, diverted, Catalog # 300-1002, is used for the delivery of granular autograft or allograft into Spineology’s OptiMesh implant. Fill tube is identified with Spineology, catalog number and lot number printed directly onto the metal. Recall # Z-0677-05; b) Fill Tube, straight, Catalog # 300-1001, is used for the delivery of granular autograft or allograft into Spineology's OptiMesh implant. Fill tube is identified with Spineology, catalog number and lot number printed directly onto the metal. Recall # Z-0678-05; c) Platen, Catalog # 301-124, is a mechanism used to lock or hold the fill tube in place as it is filled with graft material. Platen is identified with Spineology, catalog number and lot number printed directly onto the metal. Recall # Z-0679-05;
CODE 
a) Lot # UN02002, 71-1057, UN04003 and UN04004; b) Lot # UN02001, 71-1057, UN04001, UN04004, and M04041; c) Lot # UT04005.
RECALLING FIRM/MANUFACTURER 
The Spineology Group, Stillwater, MN, by product update on January 28, 2005 and by telephone between January 28 and January 31, 2005. Firm initiated recall is ongoing.
REASON 
Three malfunctions, due to jamming of bone material in the fill tube occurred. Fill tubes are used in delivery of bone graft materials.
VOLUME OF PRODUCT IN COMMERCE 
4,302 units.
DISTRIBUTION 
Nationwide and UK.

_______________________________

PRODUCT
CryoValve, Aortic Valve and Conduit. Donor #56844, Model #AV00. Recall # Z-0686-05.
CODE 
Serial #7399626.
RECALLING FIRM/MANUFACTURER 
CryoLife, Inc., Kennesaw, GA, by letter on December 2, 2004. Firm initiated recall is ongoing.
REASON 
An incorrect lot number was entered in the production record for the solution in which this allograft was packaged.
VOLUME OF PRODUCT IN COMMERCE 
1 tissue.
DISTRIBUTION 
TN.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS I

_______________________________

PRODUCT
Elanco brand Micotil 300 Tilmicosin injection, USP. 300 mg tilmicosin, USP as tilmicosin phosphate per ml in 250 ml bottles; product AH023038W. Recall # V-043-5.
CODE 
Lot 43650A; exp. September 3, 2007.
RECALLING FIRM/MANUFACTURER 
Lilly, Eli and Co., Indianapolis, IN, by letters dated January 26, 2005. Firm initiated recall is ongoing.
REASON 
The client information sheet, which warns of death if product is injected into humans, was not included in the package, although the warning is on the package itself.
VOLUME OF PRODUCT IN COMMERCE 
4,680 bottles.
DISTRIBUTION 
Nationwide.

_______________________________

PRODUCT
HighNoon Shine-Em-Up, For all cattle and sheep, packaged in 50-lb. Bags, containing 30 g/ton lasalocid. Recall # V-044-5.
CODE 
All codes manufactured since January, 2004, which would include 06250304, 07080704, AUG9-04, 01260204, 01020804, 01220203, 03250104, 05100804, 05120604, 05130204, 06090404, and DEC 14 04. Other codes could be affected.
RECALLING FIRM/MANUFACTURER 
High Noon Feeds, LLC, Bird City, KS, by telephone on December 21, 2004, between January 3 and January 5, 2005, and on January 25, 2005. Firm initiated recall is complete.
REASON 
Product contains high nonprotein nitrogen (NPN) levels.
VOLUME OF PRODUCT IN COMMERCE 
Approximately 1,121/50-lb. bags.
DISTRIBUTION
KS, OK, CO, IA, UT, and NE.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

_______________________________

PRODUCT
Pro-Pen G Injection (Penicillin G Procaine Injectable Suspension), Item 1PRO302, 250 ml, NDA 65-505. Recall # V-082-5.
CODE 
Lots PG4L021 (exp Date 11/2007); PG4L022 (exp Date 11/2007); PG5A001 (exp Date 1/08).
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Bimeda, Inc., Le Sueur, MN, by telephone on March 30, 2005 and by letter on April 1, 2005.
Manufacturer: Bimeda, Inc., Irwindale, CA. Firm initiated recall is ongoing.
REASON 
Mislabeled as to directions for use.
VOLUME OF PRODUCT IN COMMERCE 
22,085.
DISTRIBUTION 
NY, SD, IN, CA, IA, TN, OH, NC, and WI.

END OF ENFORCEMENT REPORT FOR APRIL 20, 2005

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