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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
April 20, 2005
05-16
______________________________
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.
______________________________
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.
_______________________________
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.
_______________________________
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.
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.
_______________________________
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.
______________________________
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.
_______________________________
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.
_______________________________
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.
_______________________________
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.
______________________________
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.
_______________________________
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.
_______________________________
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.
_______________________________
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.
_______________________________
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.
_______________________________
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.
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.
_______________________________
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.
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.
_______________________________
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.
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.
_______________________________
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.
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.
_______________________________
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.
_______________________________
PRODUCT
a) ENTrak Navigation and Visualization System. The particular accessories
(“Sensors”) involved are:
Recall # Z-0687-05;
b) ENTrak Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are:
Recall # Z-0688-05;
c) Insta Trak 3000 Navigation and Visualization System. The particular accessories (“Sensors”) involved are:
Recall # Z-0689-05;
d) Insta Trak 3500 Navigation and Visualization System. The particular accessories (“Sensors”) involved are:
1) Short Range Transmitter;
Recall # Z-0690-05;
e) Insta Trak 3500 Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are:
1) Short Range Transmitter;
Recall # Z-0691-05;
f) Fluro Trak 9800 Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are:
1) Short Range Transmitter;
Recall # Z-0690-05;
CODE
a), b), c), d), e) and f) 1) (P/N 1004587 or 1002008);
2) (P/N 1004069 or 1001989);
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.
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.
_______________________________
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.
_______________________________
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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