January 21, 2004
04-03
_______________________________
PRODUCT
Royal Foods brand 1/2 Diced Onion in 5 lb plastic cases.
Recall # F-064-4.
CODE
Expiration date: "08/31/03"
RECALLING FIRM/MANUFACTURER
Royal Foods Co, Inc., San Jose, CA, by letters on September 2, 2003. Firm initiated recall is complete.
REASON
The product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
512 bags.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Organic Savory Cheddar Cheese, vacuum sealed in clear plastic overwrap. Each package weighs approximately 1 lb. Product is made from unpasteurized milk. Recall # F-065-4.
CODE
DEC 01 2003.
RECALLING FIRM/MANUFACTURER
Noris Inc., Scio, OR, by telephone on October 22, 2003. Oregon State initiated recall is complete. Firm initiated recall is complete.
REASON
Product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
46/1 lb. packages.
DISTRIBUTION
OR.
_______________________________
PRODUCT
GeniSoy brand Chocolate Soy Nuts, 8 oz., in 20 gram sample
bags. Recall # F-073-4.
CODE
The products have one of the following EXP Codes or Expiration Dates: 8 0z bags: 04/09/04, 04/14/04, 04/23/04, 04/28/04, 05/27/04; 20 gram samples: 04/07/04, 04/15/04, 05/07/04.
RECALLING FIRM/MANUFACTURER
MLO Products Inc., Fairfield, CA, by letters on August 8, 2003. Firm initiated recall is complete.
REASON
The product may contain undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
15,968 lbs.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
POUND CAKE, NET WT. 12 oz. The product is packaged in a
rectangular, aluminum container with a clear,
poly-film cover. Recall # F-074-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Kwong Wah Cake Company, Inc., New York, NY, by press release on September 17, 2003. NY State initiated recall is complete.
REASON
The product contained undeclared eggs (discovered during an investigation by New York State Department of Agriculture and Markets).
VOLUME OF PRODUCT IN COMMERCE
Approx. 250 - 12 oz. packages.
DISTRIBUTION
NY, FL, MD, PA, NC, AND OH.
_______________________________
PRODUCT
EAGLE FOODS USA brand RAISIN, NET WT. 7 oz. Product is
packaged in a clear plastic container. Recall # F-075-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Mian and Sons Traders, Inc., Brooklyn, NY, by letter, dated October 30, 2003. New York State initiated recall is complete.
REASON
Undeclared sulfites (1219 ppm) based on New York State Department of Agriculture & Markets (NYSDAM) sampling & analysis.
VOLUME OF PRODUCT IN COMMERCE
76 packages.
DISTRIBUTION
NY.
_______________________________
PRODUCT
Lucerne brand Chocolate Almond Ice Cream in 1/2 gallon
Square cardboard cartons. Recall # F-076-4.
CODE
BEST BEFORE JULY 12 04 53/38 ink stamped on the end flap of the cardboard container.
RECALLING FIRM/MANUFACTURER
Safeway. Inc., Pleasanton, CA, by e-mail and press release on December 11, 2003. Firm initiated recall is complete.
REASON
The product contained undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
1,974 - 1/2 gallon containers.
DISTRIBUTION
WA, ID, AK, and OR.
_______________________________
PRODUCT
a) GRANNY'S Country Cupboard SANTA FE CLUB HERO, NET WT. 7
OZ., Sandwich # 16502. Recall # F-077-4;
b) GRANNY'S Country Cupboard SOURDOUGH CHEDDAR-HAM MELT,
NET WT. 7 OZ., Sandwich # 22105. Recall # F-078-4;
c) GRANNY'S Country Cupboard SMOKEHOUSE TURKEY, NET WT. 7
OZ., Sandwich # 22102. Recall # F-079-4.
CODE
a) "SELL BY" date of 12/10/03;
b) and c) "FRESH THRU" date of 12/13/03.
RECALLING FIRM/MANUFACTURER
Landshire Fast Foods of Milwaukee, Muskego, WI, by visit on November 15, 2003 and November 16, 2003. Wisconsin State initiated recall is complete.
REASON
The products were contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
270 sandwiches.
DISTRIBUTION
WI, and IL.
_______________________________
PRODUCT
Ready to eat Cole Slaw, packaged in 10 pound plastic
tubs under the Chariott Foods label. Recall # F-080-4.
CODE
All products on the market at the time recall was initiated.
RECALLING FIRM/MANUFACTURER
Chariott Foods Inc., Toledo, OH, by telephone on November 20, 2003. FDA initiated recall is complete.
REASON
The product contains undeclared egg yolks.
VOLUME OF PRODUCT IN COMMERCE
Approx. 80 tubs.
DISTRIBUTION
OH.
_______________________________
PRODUCT
a) Roma Italian Style Frozen Provolone Sticks sold in 10
lb. bags. Recall # F-081-4;
b) Frozen Breaded Provolone Cheese Sticks sold in 10 lb.
bags under Romayo, NF Supreme, Vola, Aldo's, Washington
Importing Company, and Anthony's brands.
Recall # F-082-4;
c) Battered Mozzarella Cheese Sticks sold in 1, 10, and 12
lb. bags under Anthony's and Assoluti brands.
Recall # F-083-4;
d) Alfredo Italian Style Breaded Mozzarella Sticks sold in
1, 10, and 12 lb. bags. Recall # F-084-4;
e) Anthony's Italian Style Deep Fried Pepperoni and Cheddar
Cheese sold in 6 lb. bags. Recall # F-085-4;
f) Anthony's Italian Style Hot Pepper Cheese Nuggets sold
in 8 lb. bags. Recall # F-086-4.
CODE
01 01 03 01 through 07 09 03 01. The code is a date code
for the production date.
RECALLING FIRM/MANUFACTURER
Anthony's Inc., Ambridge, PA, by telephone on July 22, 2003, by letters on July 25, 2003, and by press release on July 25, 2003. FDA initiated recall is complete.
REASON
a) The product contained undeclared ingredients including
eggs, yellow corn flour, wheat flour, and whey, but
bread crumbs and milk were listed on the label.
b), d), e), and f) The products contained undeclared
ingredients including yellow corn flour, wheat flour,
and whey, but bread crumbs and milk were listed on the
label;
c) The product contained undeclared ingredients including
soy flour, yellow corn flour, wheat flour, whey, and
colors - FD&C Yellow # 5, FD&C Red # 40, and FD&C Blue #
1, but whole milk was listed on the label.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
PA, NJ, NY, OH, MI, and MA.
_______________________________
PRODUCT
a) ALBACORE JERKY, Teriyaki flavor, packaged in a heat
sealed clear plastic bag, NET WT 3 oz (85.05g).
Recall # F-067-4;
ALBACORE JERKY, Hawaiian flavor, packaged in a heat
sealed clear plastic bag, NET WT 3 oz (85.05g).
Recall # F-068-4.
CODE
a) Lot number 2809 Box number 265.
b) Lot number 2809 Box number 262.
RECALLING FIRM/MANUFACTURER
Fishing Vessel St Jude, Bellevue, WA, by visit on November 17, 2003. Firm initiated recall is complete.
REASON
The products contain undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
162 bags.
DISTRIBUTION
WA and OR.
_______________________________
PRODUCT
SOUR CREAM in 1 oz. single serve portion control packs,
Plant id #36-2345. Product is packaged in cases correctly
labeled as Cream Cheese. The private label is: Glenview
Farms. Recall # F-058-4.
CODE
OCT 17L xx:xx (military time).
RECALLING FIRM/MANUFACTURER
Crowley Foods, Inc., Binghamton, NY, by letter dated October 7, 2003. FDA initiated recall is complete.
REASON
The product labeled as sour cream actually contains cream cheese.
VOLUME OF PRODUCT IN COMMERCE
50 cases x 100 units.
DISTRIBUTION
NY.
_______________________________
PRODUCT
a) Stamina-Rx(tm) Tablets, Maximum Sexual Stimulant, a dietary
supplement, sold over-the-counter, in bottles of thirty
tablets (30) and individual sample packets of two (2)
550 mg tablets labeled to contain a combination of
herbal ingredients for use as a sexual stimulant. The
primary ingredients (per tablet) listed on the
product's labeling include the following: Epimedium
Extract (leaves) Yohimbe Extract (bark), (8mg Yohimbine
alkaloids), Cnidium Extract (fruit), Xanthoparmelia
Scabrosa Extract (lichen), Gamma Amino Butyric Acid, and
L-Arginine. The product's labeling recommends a dosage
of 1 to 2 tablets prior to sexual activity.
Recall # D-094-4.
b) Stamina-Rx(tm) for Women Tablets, MAXIMUM SEXUAL ENHANCER,
Adult Dietary Supplement, sold over-the-counter, in
bottles of twelve (12) and thirty (30), as well as,
sample packets of two (2) 350 mg tablets labeled to
contain a combination of herbal ingredients to increase
sexual desire, stamina, and arousal. The primary
ingredients (per tablet) listed on the product's
labeling include the following: Mauria Puama, Epimedum
(leaves/stems) 50% Extract, Mucuna Pruriens (seed),
Herba Cistanches (root), Xanthoparmelia Scabrosa
(lichen), Cnidu Monnier (fruit), Yohimbe 8% (bark),
yields 2 mg Yohimbine Alkaloids, Ageratum (root), Gingko
Biloba (leaves), and L-Arginine HCL. The product's
labeling recommends a dosage of 1 to 2 tablets an hour
prior to sexual activity. Recall # D-095-4.
CODE
a) Lot #03141220, Expiration May 2005; Manufactured May
2003: Lot #02141484, Expiration August 2005,
Manufactured August 2002 and Lot #03141163, Expiration
April 2005, Manufactured April 2003. Lot Nos. 141-363,
141-364, 141-365, 141-366, 141-367, 141-368, 141-369,
141-370, 141-444, 141-445, 141-446,141-447 and 141-448.
b) Lot #02143579, Expiration September 2005, Manufactured
September 2002.
RECALLING FIRM/MANUFACTURER
Hi-Tech Pharmaceuticals, Inc., Norcross, GA, by letters dated August 18 and 19, 2003 and December 8, 2003. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product contains undeclared prescription ingredient Tadalafil.
VOLUME OF PRODUCT IN COMMERCE
1 million tablets per lot (4882 Cases (Blister packs)).
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Uroprin( Tablets (502.5 mg Tablet), Dietary Supplement,
sold over-the-counter, in bottles of thirty (30) 502.5
mg tablets, labeled to contain a combination of herbal
ingredients to increase sexual stamina and arousal. The
primary ingredients (per tablet) listed on the product's
labeling include the following: L-Arginine, Epimedium
20% Extract (leaf), Tribulus Terrestris 40% Extract
(fruit), Xanthoparmelia Scabrosa Extract (lichen),
Cnidium Monnier Extract (fruit), Quebracho Extract 8%
(bark), Ginkgo Biloba 24/6 (leaf), and L-Arginine
Pyroglutamate. Product is packed in clear plastic
bottles containing white oblong tablets, with NVE
debossed on one side. The product's labeling recommends
a dosage of 1 to 2 tablets prior to sexual activity.
Recall # D-096-4;
b) Cyclovar(tm) Tablets, 60 ct (250 mg. per serving),
Pharmaceutical Grade Adult Dietary Supplement, sold
over-the-counter, in bottles of sixty (60) 250 mg
tablets, labeled to contain a combination of herbal
ingredients for the support of erectile dysfunction. The
primary ingredients (per tablet) listed on the
product's labeling include the following: L-Arginine,
Cnidium Monnier Extract, Xanthoparrela Extract, ZMA,
Gamma Amino Butyric Acid, Naringen, and Quebracho
Extract. Product is packed in clear plastic bottles
containing round tablets, white with red speckles, with
CYCLOVAR debossed on one side. The product's labeling
recommends a dosage of 1 to 2 tablets 45 minutes to an
hour prior to sexual activity. Recall # D-097-4;
c) Sigra( Tablets, DIETARY SUPPLEMENT, sold over-the-
counter, in bottles of thirty (30) 550 mg tablets,
labeled to contain a combination of herbal ingredients
for the support of sexual activity. The primary
ingredients (per tablet) listed on the product's
labeling include the following: Epimedium Extract
(leaves), Herba Cistanches Extract (root),
Xanthoparmelia Scabrosa Extract (lichen), Cnidium
Extract (fruit), and Gamma Amino Butyric Acid. Products
is packed in clear plastic bottles containing blue
hexagonal, film coated tablets, debossed SIGRA on both
sides. The product's labeling recommends a dosage of 1
to 2 tablets prior to sexual activity. Recall # D-098-4;
d) Spontane-ES(tm) Tablets, Pharmaceutical Grade Adult Dietary
Supplement, sold over-the-counter, in bottles of thirty
(30) 325 mg tablets, labeled to contain a combination of
herbal ingredients for erectile dysfunction. The primary
ingredients (per tablet) listed on the product's
labeling include the following: Xanthoparmelia Scabrosa
(lichen), Cnidium Monnier (fruit), Quebracho 8 % Extract
(bark), Gingko Biloba (leaves), Mucuna Pruriens (seed),
and L-Arginine. Product is packed in clear plastic
bottles containing blue hexagonal tablets with SPON-TANE
debossed on one side and ES on the other The product's
labeling recommends a dosage of 1 to 2 tablets an hour
prior to sexual activity. Recall # D-099-4.
CODE
a) Lot #0312683, Expiration March 2005, Manufactured March
2003 and Lot#02126574, Expiration None, Manufactured
September 2002.
b) Lot #SNI734, Expiration November 2004, Manufactured
November 2002 Lot # SNI 732, expiration November 2004.
c) Lot #02144422, Expiration July 2005, Manufactured July
2002, Lot #02144423, Expiration July 2005, Manufactured
July 2002; Lot #02144425, Expiration July 2005,
Manufactured July 2002; Lot #02144426, Expiration July
2005, Manufactured July 2002.
d) Lot #02148608, Expiration None, Manufactured September
2002.
RECALLING FIRM/MANUFACTURER
National Urological Group, Inc., Norcross, GA, by letter on September 8, 2003. Firm initiated recall is ongoing.
REASON
Unapproved New Drug: tablets contain the undeclared prescription ingredient tadalafil.
VOLUME OF PRODUCT IN COMMERCE
1 million pills per lot.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Vigor-Rx Capsules, Pharmaceutical Grade Dietary Supplement,
sold over-the-counter, in bottles of sixty (60), 545 and
1002 mg capsules, labeled to contain a combination of
herbal ingredients for advanced support of healthy erectile
function. The primary ingredients (per capsules) listed on
the product's labeling include the following: Maca Extract
(root), Muira Puama Extract (root), Epimedium Extract
(leaves/stems), Cnidium Extract (fruit), Xanthoparmelia
Scabrosa Extract (lichen), L-Arginine, Erin Tree Extract
(bark), Tribulus Extract (fruit), and Forskohlii Extract
(root). Packed in clear plastic bottles, containing blue,
hard gelatin capsules, marked with three white bands and
VIGOR-Rx The product's labeling recommends a dosage of 1
to 2 capsules 30 to 45 minutes prior to sexual activity.
Recall # D-100-4.
CODE
Lot #0310484, Expiration March 2005, Manufactured March 2003.
RECALLING FIRM/MANUFACTURER
National Urological Group, Inc., Norcross, GA, by letter on September 8, 2003. Firm initiated recall is ongoing.
REASON
Unapproved New Drug: tablets contain the undeclared prescription ingredient tadalafil.
VOLUME OF PRODUCT IN COMMERCE
One million capsules (16,666 bottles).
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
APAP tablets, (Acetaminophen), 325 mg, 100 count bottles,
DIXON'S (Brand Name). Recall # D-103-4.
CODE
Lot No. 319687 Exp. 03/05 (bottom of bottle).
RECALLING FIRM/MANUFACTURER
Magno Humphries, Inc., Tigard, OR, by telephone on December 2, 2003. Firm initiated recall is ongoing.
REASON
Mislabeling- bottles labeled to contain 325 tablets actually contain 500 mg acetaminophen caplets.
VOLUME OF PRODUCT IN COMMERCE
504 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Unasyn for Injection (ampicillin sodium/sulbactam sodium)
1.5 g equivalent to 1 g ampicillin/0.5g sulbactam, 10
Single Dose ADD-Vantage Vial, For Intravenous use only, Rx
Only. Recall # D-079-4.
CODE
Lot Number/Exp. date: R283A (1 Oct 06).
RECALLING FIRM/MANUFACTURER
Pfizer Laboratories, Div Pfizer, Inc., Terre Haute, IN, by letter on November 19, 2003.
REASON
Lack of Assurance of Sterility.
VOLUME OF PRODUCT IN COMMERCE
6,629 trays of 10.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Brite Eyes (Propylene Glycol 0.2% and Polysorbate 80 .2%),
LUBRICANT EYE DROPS 15ML, FOR DRY OR IRRITATED EYES.
Recall # D-080-4.
CODE
Lot Numbers: BE23-BE27.
RECALLING FIRM/MANUFACTURER
Life Extension Foundation Buyers Club, Inc., Fort Lauderdale, FL, by letter on April 22, 2003. Firm initiated recall is complete.
REASON
Misbranding: Product used as labeled may cause burning and other irritation of the eyes.
VOLUME OF PRODUCT IN COMMERCE
19,941 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Paraplatin (carboplatin aqueous solution) Injection, 50 mg
per vial, 10 mg per mL sterile, 5 mL vials, For IV USE,
SINGLE-DOSE VIAL, Rx Only, Bristol-Myers Squibb Company
Princeton, New Jersey 08543 USA, NDC 0015-3210-30. Recall #
D-101-4.
CODE
Lot Number/Expiration Date: 3H63625 (1/31/2005).
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Co., New Brunswick, NJ, by letter on November 11/14, 2003. Firm initiated recall is ongoing.
REASON
Subpotent: (3 month stability).
VOLUME OF PRODUCT IN COMMERCE
28,027 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
FLUOXETINE CAPSULES USP, 10mg, 100 count bottles (Aqua
Blue/White), Rx Only. Recall # D-077-4.
CODE
Lot Number/Exp. Date: 106805 (04/04).
RECALLING FIRM/MANUFACTURER
IVAX Pharmaceuticals, Inc., Northvale, NJ, by letter on November 5, 2003. Firm initiated recall is ongoing.
REASON
Impurities; Total Impurity level exceeded (12 month).
VOLUME OF PRODUCT IN COMMERCE
11,204 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Butalbital, Aspirin, and Caffeine Capsules, (50 mg
Butalbital, 325 mg Aspirin, 40 mg Caffeine),100 count
bottles, Rx only. Recall # D-078-4.
CODE
Lot number M031552024.
RECALLING FIRM/MANUFACTURER
Lannett Co, Inc., Philadelphia, PA, by telephone on November 10, 2003. Firm initiated recall is ongoing.
REASON
ANDA/NDA Discrepancies: Manufacturing process used an unapproved source of butalbital.
VOLUME OF PRODUCT IN COMMERCE
4,772 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Nardil Tablets (Phenelzine Sulfate Tablets, USP), 15 mg,
100 count bottles, Rx Only. Recall # D-082-4.
CODE
Lot number/Exp. Date: 90113L (11/2003), 91913L (11/2003), 92513L (12/2003), 92613L (12/2003), 24113L (12/2003), and 24213L (1/2004).
RECALLING FIRM/MANUFACTURER
Pfizer Inc., New York, NY, by letter on November 18, 2003 and November 20, 2003. Firm initiated recall is ongoing.
REASON
Subpotent: (stability).
VOLUME OF PRODUCT IN COMMERCE
95,933 bottles.
DISTRIBUTION
Nationwide, Canada, Spain, and South Africa.
_______________________________
PRODUCT
a) Antacid (Calcium carbonate, USP 500 mg), 150 count
bottles, BARTELL DRUGS Mint Flavor Antacid Regular
Strength ANTACID/CALCIUM SUPPLEMENT SODIUM FREE/CALCIUM
RICH, The product is also labeled as BARTELL DRUGS Mint
Flavor Antacid REGULAR STRENGTH ANTACID/CALCIUM
SUPPLEMENT CALCIUM RICH. Recall # D-085-4;
b) Antacid Tablets (Calcium Carbonate USP, 750 mg) 96 count
bottles, BARTELL DRUGS Tropical Fruit Flavors Antacid
EXTRA STRENGTH ANTACID/CALCIUM SUPPLEMENT GREAT
TASTE/CALCIUM RICH. Recall # D-086-4.
CODE
a) Lot No./Expiration Date: 311476 (1/04), 309854 (11/03),
310566 (3/03), 318093 (1/04), 317253 (1/04);
b) Lot No./Expiration Date: 318125 (1/05), 319441(1/05),
321186(1/05), 322664 (3/05).
RECALLING FIRM/MANUFACTURER
Magno Humphries Inc., Tigard, OR, by letter on November 25, 2003, and December 16, 2003. FDA initiated recall is ongoing.
REASON
a) Misbranding: bottle is incorrectly labeled as containing
200 mg of calcium per serving rather than 400 mg and the
percent daily value is incorrectly denoted as 20% rather
than 40%;
b) Misbranding: bottle is incorrectly labeled as containing
20% daily value of calcium rather than correctly
containing 30% daily value of calcium.
VOLUME OF PRODUCT IN COMMERCE
5,952 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Amiodarone HCL Injection, 150 mg/3ml, 50 mg/ml, 10 x 3 mL
Single use Vial, Preservative Free, Rx only, FOR IV USE
ONLY. Recall # D-087-4.
CODE
Lot Numbers/Exp Dates: 446102 (06/04), 446103 (06/04), 446104 (07/04), 446105 (06/04), 446106 (10/04), 446107 (10/04), 446110 (10/04), 450470 (10/04), 495013 (11/04), 496062 (11/04), 496799 (11/04), 500104 (11/04), 502519 (02/05), 502522 (02/05), 508688 (06/05).
RECALLING FIRM/MANUFACTURER
Bedford Laboratories, Bedford, OH, by letter on November 2, 2003 and November 24, 2003. Firm initiated recall is ongoing
REASON
The vials contain crystalline particulate matter adhering to the bottom of the glass vials.
VOLUME OF PRODUCT IN COMMERCE
1,084,800 vials.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Buspar Tablets (buspirone HCl, USP), 15 mg, 60 Dividose
tablet and 180 Dividose tablet bottles, Rx Only.
Recall # D-088-4.
CODE
Lot No. 3G74918 Expiration Date: AUG 31, 2006 (60 count bottle) Lot No. 3D68441 Expiration Date: FEB 28, 2005 and 3B63278 Expiration Date: APR 30, 2006 (180 count bottle).
RECALLING FIRM/MANUFACTURER
Bristol Myers Squibb Co., C.P.O., Mount Vernon, IN, by certified letter on December 9, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled: Dosing instructions for the 15 mg Dividose tablet is incorrect in that the diagram for two-thirds of a tablet should denote a 10 mg dose rather than a 15 mg dose.
VOLUME OF PRODUCT IN COMMERCE
39,755 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Lithium Carbonate Extended Release Tablets, USP, 300 mg,
100 count bottle, Rx only. Recall # D-102-4.
CODE
Lot Number/Expiration Date: 403452044T (SEP 2004).
RECALLING FIRM/MANUFACTURER
Barr Laboratories, Inc., Forest, VA, by letter on December 16, 2003. Firm initiated recall is ongoing.
REASON
Dissolution Failure: 12 month stability.
VOLUME OF PRODUCT IN COMMERCE
3,165 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Human Tissue, CryoVein Saphenous Vein - Model # V010. Recall # B-0505-4.
CODE
Serial Number 798727.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc. Kennesaw, GA , by telephone on October 24, 2003. Firm initiated recall is complete.
REASON
Human tissue, collected from a donor who subsequently tested positive for HBsAg, by another tissue procurement organization, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
CA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed. Recall # B-0507-4;
b) Red Blood Cells. Recall # B-0508-4;
c) Recovered Plasma. Recall # B-0509-4.
CODE
a) Unit numbers: 9562670, 8526630, 8341903;
b) Unit numbers: 6582194, 6990834;
c) Unit numbers: 9562670, 8526630, 6582194, 8341903.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA , by letter dated June 2, 2002 and May 13, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
LA, and MI.
_____________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-0513-4.
CODE
Unit 16KF38213.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone on September 15, 2003. Firm initiated recall is complete.
REASON
Blood product, collected under conditions where the sterility of the product may have been compromised, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_____________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-0514-4.
CODE
Unit 50X20699.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone on May 29, 2003, and by letter dated May 30, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking anti-viral medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0515-4.
CODE
Units 15395-0503,15395-0505, 15395-0509.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. - Lubbock Center, Lubbock, TX, by telephone on September 24, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from donors with inaccurate hematocrit determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0516-4.
CODE
Units (12 units) 15395-6206-04710, 5395-7175-04710, 15395-5947-04741, 15395-6049-04741, 15395-6078-04741, 15395-6203-04741, 15395-6239-04741, 15395-5947-04761, 15395-6049-04761, 15395-6078-04761, 15395-6203-04761, 15395-6239-04761
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Lubbock Center, Lubbock, TX, by telephone on November 14, 2002.
Manufacturer: Blood Systems, Inc., San Angelo, TX. Firm initiated recall is complete.
REASON
Blood products, collected from donors with inaccurate hematocrit determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall #
B-0517-4.
CODE
Unit number 9559426.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on March 12, 2003. Firm initiated recall is complete.
REASON
Blood product was not irradiated but was distributed with labeling that indicated that the unit had been irradiated.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0518-4;
b) Recovered Plasma. Recall # B-0519-4.
CODE
a) and b) Unit number 8378473.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on January 23, 2003. Firm initiated recall is complete.
REASON
Blood products, that were not properly quarantined after the donor of the products reported a post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA and Switzerland.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0520-4.
CODE
Unit numbers 6597472 and 6598271.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone and letter on March 15, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0521-4.
CODE
Unit number 3813097.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA , by letter on September 24, 2001. Firm initiated recall is complete.
REASON
Blood product, that tested negative for the antibody to hepatitis B core antigen (anti-HBc), but was collected from a donor that had been previously deferred for reactive testing for anti-HBc, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0522-4;
b) Platelets. Recall # B-0523-4;
c) Fresh Frozen Plasma. Recall # B-0524-4;
d) Recovered Plasma. Recall # B-0525-4.
CODE
a) Unit numbers 01LT21495 and 01LT26998;
b) and c) Unit number 01LT21495;
d) Unit number 01LT26998.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letters on February 4 and 6, 2003.
Manufacturer: American Red Cross Blood Services, Tonawanda, NY. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that subsequently reported a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
NY and Switzerland.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0530-4.
CODE
Unit 12FV18103.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by facsimile on May 6, 2003.Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor with a history of positive test results for hepatitis B and hepatitis C, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0534-4;
b) Platelets, Leukocytes Reduced. Recall # B-0535-4;
c) Fresh Frozen Plasma. Recall # B-0536-4.
CODE
a), b) and c) unit number 33GK46079.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone on October 1, 2003, and by letter on October 3, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CT.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0539-4.
CODE
Units 15394-4205, 15394-4234, 15394-4239, 15394-4333, 15394-4335, 15394-4344, 15394-4347, 15394-4391, 15394-4406, 15394-4416, 15394-4472, 15394-4479, 15394-4481, 15394-7700, 15394-7794, 15394-7874, 15394-7977, 15394-8002, 15395-2340, 15394-4345, 15394-4350 (double collection), 15394-4394 (double collection), 15394-7851 (double collection), 15394-4366 (double collection), 15394-7701 (double collection), 15394-7945 (double collection), 15394-3057, 15394-7007.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. - Lubbock Center, Lubbock, TX, by telephone beginning September 30, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from donors with inaccurate hemoglobin determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
34 units.
DISTRIBUTION
TX, CO, and NJ.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-0540-4.
CODE
Unit 41FP40550.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone on November 29, 2002, and by letter dated December 5, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking Soriatane, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0541-4.
CODE
Unit 042J48589.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone on June 30, 2003 and by letter dated July 2, 2003. 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
OH.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0542-4.
CODE
Units 041FL97032, 041GQ09211, 041GQ06957, 041GQ02065, and 041GQ00398.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by facsimile on March 4, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0543-4.
CODE
Unit number: 15391-8373.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. Lubbock Center, Lubbock, TX, by letter, dated October 1, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX and CA.
_______________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-0545-4.
CODE
Unit number: 042KW17418.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by telephone on September 18, 2003, and by letter dated September 22, 2003. Firm initiated recall is complete.
REASON
Blood product, collected on equipment that had not been validated for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0546-4;
b) Platelets, Leukocytes Reduced. Recall # B-0547-4.
CODE
a) and b) unit number 33GE71687.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by letter on September 19, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CT and CA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes. Recall # B-0549-4;
b) Platelets, Leukocytes Reduced. Recall # B-0550-4;
c) Recovered Plasma. Recall # B-0551-4.
CODE
a), b), and c) Unit number 33GM19708.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone on September 22 and 23, 2003, and by letter on September 25, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CT and CA.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0552-4.
CODE
Unit number 17201-4699.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by telephone on July 14, 2003. Firm initiated recall is complete.
REASON
Platelets Pheresis with an elevated platelet count based on volume of product collected were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0553-4.
CODE
Unit number 18231-2655.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY, by letter on August 28, 2003. Firm initiated recall is ongoing.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WY.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0554-4.
CODE
Unit numbers 41FP39735, 41FP39767, and 41FP39761.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by telephone on September 4, 2002, and by letter dated September 12, 2002. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AL.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0555-4;
b) Fresh Frozen Plasma. Recall # B-0556-4.
CODE
a) and b) Unit number 41GM40739.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by telephone on June 29, 2001 and by letter dated August 22, 2001.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0559-4.
CODE
Unit 41GQ07121.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone on September 13, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0568-4.
CODE
Unit number: 18232-7748.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 6, 2003.
Manufacturing Firm: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, quarantined due to incomplete records, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WY.
_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0569-4;
Recovered Plasma. Recall # B-0570-4.
CODE
a) and b) Unit 18231-3841.
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Cheyenne, WY, by fax on October 9, 2003, and by letter dated November 14, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and Switzerland.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0571-4.
CODE
Unit number: 18232-8571.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc. Scottsdale, AZ, by telephone on October 3, 2003, by facsimile on October 6, 2003, and by letter dated, November 14, 2003.
Manufacturing Firm: Blood Systems, Inc., Cheyenne, WY. 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
WY and Switzerland.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0574-4.
CODE
Unit number: 18232-7057.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc. Scottsdale, AZ, by telephone on October 3, 2003, by facsimile on October 6, 2003, and by letter dated, November 14, 2003.
Manufacturing Firm: Blood Systems, Inc., Cheyenne, WY. 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
WY and Switzerland.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0595-4.
CODE
Unit 027LT20986.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone on August 28, 2003. Firm initiated recall is complete.
REASON
Red Cells, which tested positive for anti-Kell and labeled as negative for unexpected antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WV.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0606-4.
CODE
Unit numbers: 26116-4623, 26116-4643, and 26116-5675.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on April 28, 2003. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for Cytomegalovirus (CMV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AR.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0608-4;
b) Platelets Leukocytes Reduced. Recall # B-0609-4.
CODE
a) and b) Unit 1019361.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, UC Medical Center, Cincinnati, OH, by letter and facsimile on September 23, 2003. Firm initiated recall is complete.
REASON
Blood products, which initially tested negative for the antibody to the hepatitis B core antigen (HBcAb) but subsequently tested repeatedly reactive for HBcAb, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH, and FL.
_______________________________
PRODUCT
Source Plasma. Recall # B-0345-4.
CODE
Unit numbers 0181090015, 0181089703, 0181089401, 0181089172, 0181088815, 0181088543, 0181088321, 0181088052, 0181087656, 0181087416, 0181087133, 0181086834, 0181086584, 0181085724, 0181085047, 0181084848, 0181084386, 0181084056, and 0181083713.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Columbus, OH, by facsimile on June 2, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0503-4.
CODE
Units 0181083790, 0181083737, 0181084335, 0181084690, 0181085009.
RECALLING FIRM/MANUFACTURER
ZLB Plasma Services, Columbus, OH, by facsimile, dated April 15, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jakob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-510-4;
b) Fresh Frozen Plasma. Recall # B-511-4.
CODE
a) Units 15390-8839, 15394-2270;
b) Unit 15390-8839.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Lubbock Center, Lubbock, TX, by telephone on November 5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had surgery within the past 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0512-4.
CODE
Unit 042T23024.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone on October 8, 2003, and by letter dated October 8, 2003. Firm initiated recall is complete.
REASON
Red Cells, which tested Jk(a-) and labeled as Jk(b-), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
a) Cryoprecipitated AHF. Recall # B-0526-4;
b) Fresh Frozen Plasma. Recall # B-0527-4;
c) Plasma. Recall # B-0528-4.
CODE
a) Unit numbers 030GK04914, 030GL34689, 030GE33435,
030GL29636, 030GW56970, and 030GN61911;
b) Unit numbers 030GL31093 and 030GW66868;
c) Unit numbers 030GK04914, 030GL29636, and 030GN61911.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on August 6, 2003, and by letter on August 20, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood that were not correctly documented as to collection status and could not be ruled out as traumatic collections, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
PA, MA, CT, and NY.
_______________________________
PRODUCT
a) Platelets, Leukocytes Reduced. Recall # B-0532-4;
b) Fresh Frozen Plasma. Recall # B-0533-4.
CODE
a) and b) Unit number 33GK46042.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone on September 30, 2003, and by letter on October 7, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from a unit of Whole Blood that had an extended collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CT.
_______________________________
PRODUCT
a) Platelets, Leukocytes Reduced. Recall # B-0537-4;
b) Fresh Frozen Plasma. Recall # B-0538-4.
CODE
a) and b) Unit 33GM19870.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Connecticut Region, Farmington, CT, by telephone on September 22, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from a traumatic collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CT.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0544-4.
CODE
Unit number: 15391-8373.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. Lubbock Center, Lubbock, TX, by letter, dated October 1, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX and CA.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0548-4.
CODE
Unit number 33GE71687.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by letter on September 9, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT and CA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0557-4;
b) Fresh Frozen Plasma. Recall # B-0558-4.
CODE
a) and b) Unit 41GF74423.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone on April 9, 2003, and by letter dated April 14, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-0560-4.
CODE
Unit 41GP56186.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone on September 10, 2002. Firm initiated recall is complete.
REASON
Platelets, that were not stored with continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0561-4.
CODE
Units 12Y33579, 12Y33577, 12FV15779, 12733578, 12733576, 12733575, 12Q64287, 12H57731, 12GY56167, 12GY56166, 12GY56165, 12GY56163, 12GY56162, 12GY56152, 12GY54488, 12GY56157, 12GY56156, 12GY56154, 12GY56153, 12GY52527.
RECALLING FIRM/MANUFACTURER
The American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by letter dated February 21, 2003. Firm initiated recall is complete.
REASON
Red Cells, prepared more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0572-4.
CODE
Unit number: 18232-8571.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 3, 2003, by facsimile on October 6, 2003, and by letter dated, November 14, 2003.
Manufacturing Firm: Blood Systems, Inc., Cheyenne, WY. 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
WY and Switzerland.
_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0573-4.
CODE
Unit 12800-2200.
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Albuquerque, NM, by telephone on
October 13, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NM.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0575-4.
CODE
Unit number: 18232-7057.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc. Scottsdale, AZ, by telephone on October 3, 2003, by facsimile on October 6, 2003, and by letter dated, November 14, 2003.
Manufacturing Firm: Blood Systems, Inc., Cheyenne, WY. 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
WY and Switzerland.
_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Removed.
Recall # B-0602-4;
b) Plasma. Recall # B-0603-4.
CODE
a) Unit numbers: 042KW09378 (Parts 1 and 2), 042KW08360
(Parts 1 and 2), 042KW05277 (Parts 1 and 2), 042KW02313
(Parts 1 and 2), 042KW01788 (Parts 1 and 2), and
042KW00619 (Parts 1 and 2);
b) Unit number: 042KW09378.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on September 25, 2003 and letter on September 30, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was on long-term antibiotic therapy, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
OH.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0604-4;
b) Cryoprecipitated AHF. Recall # B-0605-4.
CODE
a) Units 50X02048, 50X04836, 50Y04501, and 50X10586;
b) Unit 50X02048.
RECALLING/MANUFACTURER
American Red Cross Blood Services, Toledo, OH, by letters dated April 25, April 26, and April 30, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking an anti-viral medication, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MI and OH.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0607-4.
CODE
Unit number: 26114-5572
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on May 14, 2003.Firm initiated recall is complete.
REASON
Blood product, which was incorrectly tested for antigen typing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0610-4.
CODE
Unit 1019361.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, UC Medical Center, Cincinnati, OH, by letter and facsimile on September 23, 2003. Firm initiated recall is complete.
REASON
Blood products, which initially tested negative for the antibody to the hepatitis B core antigen (HBcAb) but subsequently tested repeatedly reactive for HBcAb, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH, and FL.
_______________________________
PRODUCT
a) Ethicon Endo-Surgery Endopath ETS-Flex Articulating
Endoscopic Linear Cutter, 35mm Standard, Product #ATB35.
Recall # Z-0212-04;
b) Ethicon Endo-Surgery Endopath ETS-Flex Articulating
Endoscopic Linear Cutter, 35mm Vascular/Thin, Product
#ATW35. Recall # Z-0213-04;
c) FlexTray Procedure Delivery System Endopath Gynecology
Tray, Product #FD065. Recall # Z-0214-04;
d) FlexTray Procedure Delivery System Endopath Gynecology
Tray, Product #FD063. Recall # Z-0215-04;
e) FlexTray Procedure Delivery System Endopath Bariatric
Surgery Tray, Product #FBW24. Recall # Z-0216-04;
f) FlexTray Procedure Delivery System Endopath Gynecology
Tray, Product #FD064. Recall # Z-0217-04;
g) FlexTray Procedure Delivery System Endopath Bariatric
Surgery Tray, Product #KBW16. Recall # Z-0218-04;
h) FlexTray Procedure Delivery System Endopath Bariatric
Surgery Tray, Product #KNB21. Recall # Z-0219-04;
i) FlexTray Procedure Delivery System Endopath General
Laparoscopic Tray, Product #TGL22. Recall # Z-0220-04;
j) General Laparoscopic Tray, Product #TGL33.
Recall # Z-0221-04;
k) General Laparoscopic Tray, Product #TGL53.
Recall # Z-0222-04;
l) FlexTray Procedure Delivery System Endopath General
Laparoscopic Tray, Product #TGL56. Recall # Z-0223-04;
m) FlexTray Procedure Delivery System Endopath Gynecololgy
Tray, Product #FN065. Recall # Z-0224-04;
n) FlexTray Procedure Delivery System Endopath Gastric
Tray, Product #KGB11. Recall # Z-0225-04;
o) FlexTray Procedure Delivery System Endopath General
Laparoscopic Tray, Product #TGL45. Recall # Z-0226-04.
CODE
a) Lot Numbers: T4VP02, T4VU1R, T4VV8G, T4VY38, T4W14P,
T4W31X, T4W40L, T4W49R, T4W78J, T4W94K, T4W94L, T4WD1Z,
T4WE79, T4WG29, T4WH7T, T4WP20, T4WP6M, T4WR1U, T4WV5C,
T4WV5D, T4WX38, T4WY96, T4WY9P, T4WZ5H, T4X06W, T4X19X,
T4X19Y, T4X21T, T4X54V, T4X84D, T4XC4X, T4XC4Y, T4XD42,
T4XD46, T4XE9P, T4XF1L, T4XM0T, T4XM0U, T4XN1K, T4XV2R,
T4XV2T, T4XW1U, T4XW1V, T4XZ65, T4Y28Z, T4Y465, T4Y466,
T4Y77P, T4Y801.
b) Lot Numbers: T4VM9R, T4VN0R, T4VNOX, T4VP71, T4VR0U,
T4VR3F, T4VR8Z, T4VT68, T4VT75, T4VU1Z, T4VV8U, T4VW33,
T4VW34, T4VW7F, T4VW97, T4VX7P, T4VX7R, T4W03T, T4W11A,
T4W11X, T4W188, T4W189, T4W31Y, T4W66N, T4W66T, T4W67V,
T4W70V, T4W86G, T4W86H, T4W86N, T4WA3R, T4WA6T, T4WA9Z,
T4WD68, T4WD6L, T4WD6M, T4WG04, T4WG05, T4WG4K, T4WG6T,
T4WG90, T4WH0K, T4WH5J, T4WH5X, T4WH7N, T4WH9G, T4WK6Z,
T4WK70, T4WL2U, T4WM6V, T4WN19, T4WN2K, T4WT0F, T4WT0G,
T4WU2P, T4WU4L, T4WU5G, T4WU9W, T4WV7E, T4WV8X, T4WX7E,
T4WY7P, T4WY7R, T4WZ62, T4X11U, T4X15M, T4X16G, T4X27L,
T4X28X, T4X35P, T4X367, T4X46T, T4X46U, T4X631, T4X634,
T4X706, T4X707, T4X708, T4X78T, T4X83P, T4X904, T4X905,
T4X929, T4XA2Z, T4XA30, T4XC31, T4XE0A, T4XE20, T4XE21,
T4XE8Z, T4XE9M, T4XE9N, T4XG9Y, T4XG9Z, T4XH00, T4XH01,
T4XK06, T4XK08, T4XK09, T4XM47, T4XM48, T4XM7L, T4XN4Z,
T4XN53, T4XN5N, T4XR2N, T4XR2R, T4XT15, T4XU8W, T4XV2K,
T4XV2N, T4XW40, T4XW79, T4XZ9L, T4Y01X, T4Y02U, T4Y16K,
T4Y16L, T4Y16M, T4Y21N, T4Y21P, T4Y21R, T4Y26W, T4Y26X,
T4Y272, T4Y39G, T4Y39L, T4Y634, T4Y635, T4Y636, T4Y75M,
T4Y75N, T4Y75P, T4Y75R, T4Y75T, T4YA05, T4YA06, T4YC2K,
T4YC2M, T4YC2P;
c) Lot Numbers: T4W63C, T4WA2D, T4WD82, T4WT5U, T4Y19Z;
d) Lot Numbers: T4W23Y, T4WA33, T4WN15, T4WN5A, T4XY22,
T4XZ1E;
e) Lot Numbers: T4VZ68, T4W30K, T4W881, T4WL7Z, T4WR5X,
T4WT38, T4WY34, T4X38G, T4X52L, T4YC9J;
f) Lot Numbers: T4W19H, T4WN1J;
g) Lot Numbers: T4XD0F, T4XK71;
h) Lot Numbers: T4VT9K, T4Y61F;
i) Lot Numbers: T4VU41, T4VY0X, T4W345, T4W346, T4WY38,
T4X059, T4X33K, T4YC9Z, T4YE00;
j) Lot Numbers: T4WF6D, T4WT8Y, T4X52J, T4Y03E;
k) Lot Numbers: T4WP5P;
l) Lot Numbers: T4YD0G;
m) Lot Numbers: T4VX78, T4WK0G, T4WL8T, T4XH6P, T4Y96L;
n) Lot Numbers: T4VN3C, T4W02R, T4W76M, T4WA05, T4WK2N,
T4X33J.
o) Lot Numbers: T4WX67, T4X22Y, T4X95D, T4XG4C, T4XK7M,
T4XM7U, T4XY24, T4Y32W.
RECALLING FIRM/MANUFACTURER
Ethicon Endo-Surgery, Cincinnati, OH, by letter on November 25, 2003. Firm initiated recall is ongoing.
REASON
A defective articulation band may result in improper staple formation with possible hematosis.
VOLUME OF PRODUCT IN COMMERCE
67,530 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
ISPAN patient bracelet, given to patients post surgery to
warn of further use of dinitrogen monoxide. Recall # Z-
0229-04.
CODE
All lots of the German translated patient bracelets.
RECALLING FIRM/MANUFACTURER
Alcon Laboratories, Inc., Fort Worth, TX, by letters, on November 18, 2003. Firm initiated recall is ongoing.
REASON
The patient bracelet that is given to patients post surgery after administering either ISPAN Perfluoropropane or ISPAN Sulfur Hexafluordie referred to the term, "stickoxid", which is the general term for nitrogen oxide and may be interpreted as either nitrogen monoxide (NO) or dinitrogen monxoide. The firm is recalling the old (blue) bracelets and replacing them with new (gray) bracelets that now reference the specific term dinitrogen monoxide N20 (laughing gas).
VOLUME OF PRODUCT IN COMMERCE
3,142.
DISTRIBUTION
Germany, Switzerland, and Austria.
_______________________________
PRODUCT
IMx Tacrolimus II Assay, list 3C10-20. Recall # Z-0230-04.
CODE
All lot numbers.
RECALLING FIRM
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letters dated November 12, 2003. FDA initiated recall is ongoing.
REASON
Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances.
VOLUME OF PRODUCT IN COMMERCE
Unspecified.
DISTRIBUTION
Nationwide, and Internationally.
_______________________________
PRODUCT
Fix pins associated with Stealth Station Treatment Guidance
Platform. Recall # Z-0231-04.
CODE
3" fix pin - 9730476, Lot numbers 200302130552, 200302140566 and 200302260619. 5" fix pin - 9730477, Lot numbers 200302140564, and 200303030641.
RECALLING FIRM/MANUFACTURER
Medtronic Surgical Navigation Tech, Inc., Louisville, CO, by letter on November 1, 2003. Firm initiated recall is complete.
REASON
Surgical devices intended for single use were not labeled for single use.
VOLUME OF PRODUCT IN COMMERCE
127 devices.
DISTRIBUTION
CA, FL, GA, KS, TX, Belgium, France, Germany, Hong Kong, and Japan.
_______________________________
PRODUCT
Calculator/Data Processing Module for Clinical Use. Recall
# Z-0235-04.
CODE
Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by facsimile on September 25, 2003. Firm initiated recall is ongoing.
REASON
Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks.
VOLUME OF PRODUCT IN COMMERCE
485.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) 3M Attest 1264 Biological Indicators, in boxes of 100
per box. Recall # Z-0236-04;
b) 3M Attest 1264P Biological Indicators, in boxes of 25
per box. Recall # Z-0237-04.
CODE
a) Lot numbers 2005-07 DR, 2005-07 DS, 2005-07 DT, 2005-07
DU, 2005-08 DA, 2005-08 DB, 2005-08 DC, 2005-08 DN, and
2005-08 DO;
b) Lot numbers 2005-07 DW, 2005-08 DD, and 2005-08 DL.
RECALLING FIRM/MANUFACTURER
3m Health Care, Saint Paul, MN, by letters dated October 24, 2003 and field correction. Firm initiated recall is ongoing.
REASON
The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation.
VOLUME OF PRODUCT IN COMMERCE
11,436 boxes (25 to 100 biologic indicators per box).
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Misys Laboratory System. Recall # Z-0238-04.
CODE
Version 5.3 build 63 through Version 5.3.2 with LabAccess Results are affected.
RECALLING FIRM/MANUFACTURER
Misys Healthcare System, Tucson, AZ, by fax on July 21, 2003. Firm initiated recall is ongoing.
REASON
Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients.
VOLUME OF PRODUCT IN COMMERCE
125.
DISTRIBUTION
Nationwide, Canada, Saudi Arabia, United Kingdom.
_______________________________
PRODUCT
AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01;
7D75-20; 7D75-30. Recall # Z-0240-04.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Diagnostic Div, South Pasadena, CA, by letter dated November 24, 2003. Firm initiated recall is ongoing.
REASON
False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.
VOLUME OF PRODUCT IN COMMERCE
Information not available. 192 domestic consignees.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Phototherapy Lamp, Model 9001W501JE. Recall # Z-0241-04.
CODE
The potentially affected lamps have serial numbers within the following ranges: 2000 SN 00501XXxxxxx SN 501XXxxxxx SN 2000-501XXxxxxx 2001 SN 2001-501XXxxxxx SN 01-xx xx xxxxxx 2002 SN 02 xx xx xxxxxx 2003 SN 03 xx xx xxxxxx.
RECALLING FIRM/MANUFACTURER
Fisher & Paykel Healthcare, Inc., Laguna Hills, CA, by letter on December 5, 2003. Firm initiated recall is ongoing.
REASON
Component placement presents risk of electrocution to patients.
VOLUME OF PRODUCT IN COMMERCE
88
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
VAMP Direct Draw, Model VMP700 Needleless cannula for
sampling blood. Recall # Z-0242-04.
CODE
Lot 58151473.
RECALLING FIRM/MANUFACTURER
Edwards Lifesciences AG, Haina, San Cristobal, DO, by letter on November 20, 2003. Firm initiated recall is ongoing.
REASON
Seal integrity, sterility not assured.
VOLUME OF PRODUCT IN COMMERCE
21,150.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Prolene Polyproplyene Mesh, 3" x 6", Nonabsorbable
Synthetic Surgical Mesh; six packages per box; sterile;
product code PMII; Recall # Z-0243-04.
CODE
Catalog number PMII, lot numbers RBE609, expiration date 1/07, and RJJ130, expiration date 7/07 Note: any box with an orange dot on the end of the box is suspected counterfeit product, regardless of lot number.
RECALLING FIRM/MANUFACTURER
Cardinal Health, McGaw Park, IL, by letter dated November 3, 2003 and November 11, 2003. Firm initiated recall is ongoing.
REASON
Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII.
VOLUME OF PRODUCT IN COMMERCE
365 boxes.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a
disposable one piece cuff, for single patient use only.
Sold under the Welch Allyn "Tycos" and Allegiance
"Tactics" labels. The "4" represents the cuff size. (4
= 6.9 to 11.7 cm). These are sold in various
configurations and assigned different part numbers.
Devices are labeled as follows: Welch Allyn Tycos
#5082-104-1 (10 pack/1 tube); Welch Allyn Tycos
#5082-241-9 (5 pack/1 tube, multi-size pack); Allegiance
Tactics #30502-113S (case of 40/1tube);
Welch Allyn Tycos/Allegiance #5082-241-15 (5 pack/1
tube, multi-size pack); Recall # Z-0244-04.
b) NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a
disposable one piece cuff, for single patient use only.
Sold under the Welch Allyn "Tycos" and Allegiance
"Tactics" labels. The "4" represents the cuff size.
(4 = 6.9 to 11.7 cm). These are sold in various
configurations and assigned different part numbers.
Devices are labeled as follows: Welch Allyn Tycos #5082-
104-2 (10 pack/2 tubes); Welch Allyn Tycos #5082-104-2CL
(10 pack/2 tubes, with clamp); Welch Allyn Tycos #5082-
241-10 (5 pack/2 tubes, multi-size pack); Allegiance
Tactics #30502-113 (case of 40/2 tubes); Allegiance
Tactics #30502-213 (case of 40/2 tubes, with clamp);
Welch Allyn Tycos/Allegiance #5082-241-16. Recall # Z-
0245-04.
CODE
a) Code dates between June 20, 2003 and October 8, 2003.
(Codes found on the outer carton only.);
b) Code dates between June 20, 2003 and October 8, 2003.
(Codes found on outer carton only.).
RECALLING FIRM/MANUFACTURER
Welch Allyn, Inc., Skaneateles Falls, NY, by letters dated October 27, 2003. Firm initiated recall is ongoing.
REASON
Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading.
VOLUME OF PRODUCT IN COMMERCE
26,190 units.
DISTRIBUTION
Nationwide, Singapore, Ireland, Australia, and South Africa.
_______________________________
PRODUCT
Product is a surgical device packaged in a box which is
labeled as Sterile with the following identification: "PMII
PROLENE Mesh Polypropylene Nonabsorbable Synthetic surgical
Mesh ETHICON" Additional infomation including comparisons
between authentic Ethicon product and counterfeit are
available at the following website:
CODE
The firm found in their inventory codes listed in the Ethicon notice of lot numbers RBE609 (expiration date 1/07) and RJJ130 (expiration date 7/07).
RECALLING FIRM/MANUFACTURER
Q-Med Corporation, Ft Lauderdale, FL, by letter and telephone on October 30, 2003. Firm initiated recall is ongoing.
REASON
This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark.
VOLUME OF PRODUCT IN COMMERCE
1,250 boxes of six.
DISTRIBUTION
VA, and IL.
_______________________________
PRODUCT
a) Smith & Nephew Endocoupler C-Mount 30mm Focal Length
Reference: 7204823 and 7204823S (S indicates unit
previously serviced). Recall # Z-0247-04;
b) Smith & Nephew Endocoupler C-Mount 35 mm Focal Length
Reference :7204614 and 7204614S (S indicates unit
previously serviced). Recall # Z-0248-04.
CODE
a) Part Number: 7204823, Camera Coupler, C-Mount, 30mm F.L.
Serial Numbers (SR prefix): 8632 8646 8652 8659 8670
8679 8693 8709 8714 8633 8647 8655 8660 8675 8686 8694
8711 8716 8635 8648 8657 8665 8676 8687 8712 8727 8636
8649 8658 8668 8677 8691 8707 8713 8728 Part Number:
7204823S, Camera Coupler, C-Mount, 30mm F.L. Serial
Number SR8705;
b) Number: 7204614, Camera Coupler, C-Mount, 35mm F.L.
Serial Numbers (QW prefix): 15601 16920 16981 18031
18066 18111 18143 18276 18354 15603 16924 16982 18032
18067 18112 18147 18278 18355 15604 16927 16983 18033
18068 18113 18149 18282 18358 15605 16932 16985 18035
18069 18114 18157 18283 18359 15607 16933 16987 18036
18070 18116 18158 18284 18362 15606 16935 16988 18039
18071 18118 18168 18288 18363 15609 16936 16989 18040
18072 18119 18169 18289 18370 15612 16950 16990 18041
18073 18120 18177 18291 18382 15617 16951 16991 18042
18074 18121 18187 18292 18391 15622 16957 16992 18043
18075 18122 18188 18295 18399 15623 16958 16993 18044
18076 18123 18189 18296 18445 15626 16961 16994 18045
18077 18125 18198 18300 18460 15630 16962 17005 18046
18078 18126 18199 18301 18461 16697 16964 17006 18047
18079 18127 18200 18303 18462 16713 16965 17025 18048
18080 18128 18201 18304 18464 16719 16966 17029 18049
18084 18129 18203 18306 18469 16720 16967 17030 18050
18088 18130 18204 18307 18470 16722 16968 17045 18051
18093 18131 18205 18308 18471 16726 16969 17050 18052
18097 18132 18206 18309 18476 16729 16970 17052 18053
18098 18133 18207 18310 18477 16797 16971 17068 18054
18100 18134 18209 18315 18478 16891 16972 17069 18055
18101 18135 18210 18325 18479 16897 16973 17092 18056
18102 18136 18212 18326 18480 16898 16974 17100 18057
18103 18137 18219 18336 16899 16975 18000 18059 18104
18138 18239 18342 16907 16976 18001 18060 18105 18139
18258 18346 16914 16977 18024 18062 18107 18140 18266
18351 16915 16978 18029 18063 18108 18141 18269 18352
16916 16980 18030 18064 18110 18142 18275 18353 Part
Number: 7204614S, Camera Coupler, C-Mount, 35mm F.L.
Serial Numbers (QW prefix): 18034 18096 18160 18259
18297 18383 18416 18434 18453 18038 18099 18161 18260
18313 18384 18417 18435 18454 18058 18106 18162 18261
18314 18385 18418 18436 18455 18061 18109 18163 18262
18316 18386 18419 18437 18456 18065 18115 18164 18263
18323 18393 18420 18438 18457 18081 18144 18165 18264
18324 18394 18421 18439 18458 18082 18145 18166 18267
18333 18395 18422 18440 18459 18083 18146 18167 18270
18334 18402 18423 18441 18463 18085 18148 18170 18272
18335 18403 18424 18442 18465 18086 18150 18171 18273
18344 18404 18425 18443 18466 18087 18151 18172 18274
18345 18405 18426 18444 18467 18089 18152 18231 18277
18356 18408 18427 18446 18472 18090 18153 18232 18279
18364 18411 18428 18447 18473 18091 18154 18246 18285
18366 18412 18429 18448 18474 18092 18155 18250 18287
18373 18413 18430 18450 18475 18094 18156 18256 18293
18374 18414 18431 18451 18095 18159 18257 18294 18376
18415 18433 18452.
RECALLING FIRM/MANUFACTURER
Smith And Nephew, Inc., Endoscopy Division, Andover, MA, by letter on October 15, 2003. Firm initiated recall is ongoing.
REASON
Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
VOLUME OF PRODUCT IN COMMERCE
447 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
PROLENE* Mesh, Polypropylene Non Absorbable Synthetic
Surgical Mesh, PMII, 3"x 6", each mesh in a sealed pouch
package, 6 packages per papercard carton.
Recall # Z-0249-04.
CODE
All codes, including the lots that the manufacturer of authentic product specified as counterfeit, RBE609 EXP1/07 and RJJ130 EXP 7/07.
RECALLING FIRM/MANUFACTURER
McKesson General Medical Corporation, Richmond, VA, by e-mail on October 29, 2003 and recall notification on October 30, 2003. Firm initiated recall is ongoing.
REASON
Counterfeit product is an unapproved medical device with associated potential health hazard.
VOLUME OF PRODUCT IN COMMERCE
180 cartons (6 each/carton).
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Solar 9500 Information Monitor. Recall # Z-0250-04.
CODE
Software version 3A.
RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by letter dated November 10, 2003. Firm initiated recall is ongoing.
REASON
Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first.
VOLUME OF PRODUCT IN COMMERCE
Maximum 648 Solar 9500s with Version 3A software (297 Solar 9500 Version. 3A software were manufactured plus 131 software update kits to update multiple).
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
PROLENE* Mesh, Polypropylene Non Absorbable Synthetic
Surgical Mesh, PMII, 3"x6", each mesh in a sealed pouch
package, 6 packages per papercard carton. ***STERILE:
Sterility of contents guaranteed unless package has been
opened or damaged*** Recall # Z-0251-04.
CODE
Lots RBE609 EXP 1/07, RJJ130 EXP7/07.
RECALLING FIRM/MANUFACTURER
Owens & Minor Distribution, Inc., Glen Allen, VA, by e-mail on October 31, 2003 and by letter on November 3, 2003. Firm initiated recall is ongoing.
REASON
Counterfeit product is an unapproved medical device with associated potential health hazard.
VOLUME OF PRODUCT IN COMMERCE
423 cartons (6 meshes/carton).
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Irrigation aspiration system with double spike tubing
and 33 cm probe, latex free, catalog # 55060. Sterile,
single use. HYDRO-PRO brand and Quanta Technologies
L.L.C. brand. Recall # Z-0258-04;
b) Irrigation aspiration system for Nexhat Dorsey type
pumps with 33 cm probe and tubing, latex free, catalog #
55050. HYDRO-PRO brand. Recall # Z-0259-04;
c) Reorder # Lapkit 3. Contents: 1- 55060
suction/irrigation valve 2- 30012 insufflations tubing
set 3- 5010 anti fog solution with sponge. Sterile.
single use. Quanta Technologies L.L.C. brand.
Recall # Z-0260-04;
d) Auto Suture IRRIVAC MAX Suction irrigation system with 5
mm, 33 cm probe with double spike tubing. Sterile,
single use. Catalog # 200-20. Tyco/Healthcare/United
States Surgical brand. Recall # Z-0261-04.
CODE
a) Lot 50904994;
b) Lot 50904971;
c) Lot 994986;
d) Lots 50904937 and 50904995.
RECALLING FIRM/MANUFACTURER
Vital Concepts, Inc., Grand Rapids, MI, by letters dated November 7, 2003. Firm initiated recall is ongoing.
REASON
The probe may separate from the cannula.
VOLUME OF PRODUCT IN COMMERCE
3,273
DISTRIBUTION
AZ, IL, IN, MI, and PA.
_______________________________
PRODUCT
a) The ARCHITECT i2000, Clinical Chemistry Analyzer.
Recall # Z-0262-04;
b) The ARCHITECT c8000, Clinical Chemistry Analyzer,
Recall # Z-0263-04.
CODE
a) List number 3M74-01, all serial numbers;
b) List Number 1G06-01, all serial numbers.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on November 17, 2003. Firm initiated recall is ongoing.
REASON
Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234).
VOLUME OF PRODUCT IN COMMERCE
371.
DISTRIBUTION
TX, PA, SC, CA, IN, and Internationally.
_______________________________
PRODUCT
CX9625 Light Pipe (25 Gauge). The product is sold in packs
containing six pipes. Recall # Z- 0264-04.
CODE
Lot numbers: 207089, 209102, 02121321, 02171838, 02192048, 02212272, 02222332, 02242552, 02262741, 02272856, 02293066, 02313269, 02323381, 02333458, 02363752, 02383927, 02404141, 02414225, 02424507, 02434421, 02434520, 02444529, 02454627, 02454672, 02464725, 02474823, 02484921, 02505121, 03020326, 03040522, 03040669, 03060728, 03060803, 03060865, 03080924, 03101124, 03111222, 03131428, 03151624, 03171820, 03171998, 03192023, 03212226, 03212370, 03232422, 03242537, 03252628, 03262726, 03303276, and 03303313.
RECALLING FIRM/MANUFACTURER
Bausch & Lomb, Inc., Rochester, NY, by a recall notification dated November 13, 2003. Firm initiated recall is ongoing.
REASON
The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction.
VOLUME OF PRODUCT IN COMMERCE
2,500 six packs.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ.
Recall # Z-0266-04.
CODE
Lot numbers 548727, 548723, 544906, 542967, 542966.
RECALLING FIRM/MANUFACTURER
Cardinal Health, McGaw Park, IL, by salesman visit on November 15, 2003 and by letter dated November 18, 2003. Firm initiated recall is ongoing.
REASON
The Namic Angiography Kit attached to the outside top of the Custom Sterile Pack is not sterile.
VOLUME OF PRODUCT IN COMMERCE
1,083 packs.
DISTRIBUTION
GA, and AL.
_______________________________
PRODUCT
Stryker brand Model 1550 Synergy Extended Stay Stretcher.
Recall # Z-0267-04.
CODE
All stretchers manufactured between 1/1/1993 and 11/07/2003.
RECALLING FIRM/MANUFACTURER
Stryker Medical, Kalamazoo, MI, by letters dated December 1, 2003. FDA initiated recall is ongoing.
REASON
The user may be pinched by the siderail when raising or lowering the siderail.
VOLUME OF PRODUCT IN COMMERCE
3,903.
DISTRIBUTION
Nationwide, Canada, Hong Kong, Israel, Mexico and Syria.
_______________________________
PRODUCT
Bucky Diagnost FS Part number 9890-010-83651.
Recall # Z-0268-04.
CODE
Site numbers: 504495, 105355, 104447. The firm uses site numbers instead of serial numbers.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales & Service Region No American, Bothell, WA. Firm initiated recall is ongoing.
REASON
Support chain attachment on the Bucky carriage may fail and cause the counter weights or X-ray tube to fall.
VOLUME OF PRODUCT IN COMMERCE
3 devices.
DISTRIBUTION
FL, NY, and CA.
_______________________________
PRODUCT
IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents
packaged with Ion Capture Reaction Cells) and list 2220-20
(100 tests - reagents alone). Recall # Z-0293-04.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by e-mail on November 23, 2003 and by letters dated November 24, 2003. FDA initiated recall is ongoing.
REASON
Chemotherapeutic concentrations of methotrexate in patient samples may carryover to subsequent samples, which would result in falsely elevated folate values, when performing IMx Folate testing.
VOLUME OF PRODUCT IN COMMERCE
3,475 packs.
DISTRIBUTION
Internationally.
_______________________________
PRODUCT
Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF
189 6836, 100 coated wells per pack. Recall # Z-0298-04.
CODE
Lot 611, Exp. 25 June 2004.
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by telephone and letter on November 26, 2003. Firm initiated recall is ongoing.
REASON
Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
VOLUME OF PRODUCT IN COMMERCE
774 reagent packs.
DISTRIBUTION
Nationwide and Canada.
_______________________________
PRODUCT
MVP-10 Pediatric/ Neonatal Volume Ventilator.
Recall # Z-0300-04.
CODE
S/N: 3023031, 3025031, 0957951.
RECALLING FIRM/MANUFACTURER
Bio-Med Devices, Inc., Guilford, CT, by telephone on November 7, 2003. Firm initiated recall is complete.
REASON
Two way relief valve may fail to activate at the low negative pressure of -3cm H2O.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
ID, PA, and TX.
_______________________________
PRODUCT
a) Hill-Rom Newborn bassinet; model P247. Recall # Z-0302-
04;
b) Hill-Rom Newborn bassinet; model P248. Recall # Z-0303-
04.
CODE
All units distributed between May 1989 and March 2001.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letters dated December 19, 2003. Firm initiated recall is ongoing.
REASON
The caster/wheel may come off of the bassinet, causing the bassinet to tip.
VOLUME OF PRODUCT IN COMMERCE
8,257.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Stryker brand Synergy extended stay stretcher; model 1050.
Recall # Z-0304-04.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Stryker Medical, Kalamazoo, MI, by letter dated December 30, 2003. Firm initiated recall is ongoing.
REASON
Users may be pinched in the side-rail assembly when raising or lowering the side-rail.
VOLUME OF PRODUCT IN COMMERCE
107.
DISTRIBUTION
Nationwide and Colombia.
_______________________________
PRODUCT
Performix X-ray Tube - Performix ADV, Performix Ultra,
Solarix 630. Recall # Z-0306-04.
CODE
Tube Catalog #'s D3132, D3172, D3182, and D3152 used on Gantry model #'s 2137130, 2137130-5, 2234921-3, 2260619, 2260619-3, 2281177, 2281177-2, 2281177-3, 2281177-4, 2305500, 2339985, 2341799, 2362605, and 5101272.
RECALLING FIRM/MANUFACTURER
General Electric Med Systems, Waukesha, WI, by letter on December 8, 2003. Firm initiated recall is ongoing.
REASON
Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall.
VOLUME OF PRODUCT IN COMMERCE
400.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Eclipse Infusion Pump, 250 ml X 250 ml per hour) Part
5001247. Recall Z-0312-04.
CODE
Lot 262073.
RECALLING FIRM/MANUFACTURER
I-Flow Corporation, Lake Forest, CA, by telephone on August 19, 2002 and by letter on August 27, 2002. Firm initiated recall is complete.
REASON
Slower than expected infusion of medications, such as antibiotics.
VOLUME OF PRODUCT IN COMMERCE
3,240.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Easypump LT 100-200 Elastomeric Infusion Pump (100 ml x 0.5
ml/hr) Part number: 5001120. Recall # Z-0313-04.
CODE
Lot number 132185.
RECALLING FIRM/MANUFACTURER
I-Flow Corporation, Lake Forest, CA, by letter on August 23, 2002. Firm initiated recall is complete.
REASON
Some pumps run at 2 ml/hr instead of 0.5 ml/hr.
VOLUME OF PRODUCT IN COMMERCE
950.
DISTRIBUTION
France.
_______________________________
PRODUCT
a) Bard(r) Dimension(tm) Stone Basket, Rx only, Sterile.
Recall # Z-0314-04;
b) Bard(r) Platinum Class(tm) II Flat Wire Stone Basket,
Ureteral Stone Dislodger, Rx only, Sterile.
Recall # Z-0315-04.
CODE
a) Catalog numbers: 042310, 042313, 042316, 043310, 043313,
043316, 045215, 045290, 045315, 045390 and 045490;
b) Catalog numbers: 042310, 042313, 042316, 043310, 043313,
043316, 045215, 045290, 045315, 045390 and 045490.
RECALLING FIRM/MANUFACTURER
C. R. Bard, Inc., Urological Division, Covington, GA, by letter on December 22, 2003. Firm initiated recall is ongoing.
REASON
Product packaging may contain holes compromising sterility.
VOLUME OF PRODUCT IN COMMERCE
12,684 units.
DISTRIBUTION
Nationwide, Canada, Belgium and Japan.
_______________________________
PRODUCT
VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT
STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase
Receptable) pouches, 1 x 1.5 ml LYT C1 (human)
(positive control bottle), 1 x 1.5 ml LYT C2 (human)
(negative control bottle), and 1 x 1.5 ml LYT S1 (human)
(standard bottle). Recall # Z-0316-04.
CODE
Lot #777450001.
RECALLING FIRM/MANUFACTURER
Biomerieux, Inc., Durham, NC, by letters dated October 28, 2003. Firm initiated recall is ongoing.
REASON
Kit may contain incorrect components.
VOLUME OF PRODUCT IN COMMERCE
329 kits.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) AxSYM Tricyclic Antidepressants Reagent.
Recall # Z-0323-04;
b) ADx Tricyclic Antidepressants Reagent.
Recall # Z-0324-04;
c) TDx/TDxFLx Tricyclic Antidepressants Reagent.
Recall # Z-0325-04.
CODE
a) Product list number: 3B34-20;
b) Product List number: 9681-55;
c) Product List number: 9681-60.
RECALLING FIRM/MANUFACTURER
Abbott Health Products, Inc., Barceloneta, PR, by letter dated November 17, 2003. Firm initiated recall is ongoing.
REASON
Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.
VOLUME OF PRODUCT IN COMMERCE
Information not provided. 532 domestic consignees.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Roche brand OMNI 7 clinical chemistry analyzer; catalog
numbers GD0435 and GD0435R. Recall # Z-0326-04;
b) Roche brand OMNI 8 clinical chemistry analyzer; catalog
numbers GD0455 and GD0455R. Recall # Z-0327-04;
Roche brand OMNI 9 clinical chemistry analyzer; catalog
numbers GD0475, GD0475R and GD047591.
Recall # Z-0328-04.
CODE
All units with software version 5.61 or below.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter on or about December 15, 2003. FDA initiated recall is ongoing.
REASON
If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
VOLUME OF PRODUCT IN COMMERCE
131.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and
GD0315R. Recall # Z-0329-04;
b) Roche brand OMNI 2 Analyzer; catalog numbers GD0335 and
GD0335R. Recall # Z-0330-04;
c) Roche brand OMNI 3 Analyzer; catalog numbers GD0355,
GD0355R and GD035591.Recall # Z-0331-04;
d) Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and
GD0375R . Recall # Z-0332-04;
e) Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and
GD0395R. Recall # Z-0333-04;
f) Roche brand OMNI 6 Analyzer; catalog numbers GD0415,
GD0415R and GD041591. Recall # Z-0334-04;
g) Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and
GD0435R. Recall # Z-0335-04;
h) Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and
GD0455R.Recall # Z-0336-04;
i) Roche brand OMNI 9 Analyzer; catalog numbers GD0475,
GD0475R and GD047591. Recall # Z-0337-04.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter dated December 29, 2003. Firm initiated recall is ongoing.
REASON
The firm is withdrawing claims that pleural, pericardial, ascetic and cerebrospinal fluids are appropriate sample types for use on these instruments.
VOLUME OF PRODUCT IN COMMERCE
745.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Hill-Rom brand Century+ bed; model P1400. Recall # Z-0338-
04.
CODE
All beds distributed between August 3, 2003 and August 20, 2003.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated December 26, 2003. Firm initiated recall is ongoing.
REASON
If fluid is spilled on the siderail or the bed control areas, the bed may change positions without user input.
VOLUME OF PRODUCT IN COMMERCE
222.
DISTRIBUTION
Nationwide, Canada, Panama and Taiwan.
_______________________________
PRODUCT
Hip Stem, Sterile Pkg. The implant consists of 2 metal
components which fit together to form a femoral stem.
Recall # Z-0339-04.
CODE
Catalog numbers, 11911, 11912, 11913, 11914, 11930, 11931.
RECALLING FIRM/MANUFACTURER
Plus Orthopedics, San Diego, CA, by telephone, on September 19, 2003. Firm initiated recall is ongoing.
REASON
Design Change.
VOLUME OF PRODUCT IN COMMERCE
53.
DISTRIBUTION
CA, AZ, NV, and CO.
_______________________________
PRODUCT
a) Baxter HomeChoice Automated PD Set with Lineo
Connector, 4-prong, product codes R5C4479Q (English) and
N5C4479Q (dual English/French label); 30 units per
case. Recall # Z-0340-04;
b) Baxter Lineo Opticap Disconnect Cap, product codes
R5C4599Q (English) and N5C4599Q (dual English/French
label); 30 units per case. Recall # Z-0341-04.
CODE
a) Product code R5C4479Q, lots H03J01492, H03J17027 and
H03J24056 and product code N5C4479Q, lots H03I10114,
H03I12078, H03J05030 and H03J15088.
b) Product code R5C4599Q, lots H03J02029 and H03J27067 and
product code N5C4599Q, lots H03I18083, H03I23018 and
H03J29022.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL, by letters dated December 5, 2003 and December 8, 2003. Firm initiated recall is ongoing.
REASON
Reports of loosening of the connections and disconnection of the device.
VOLUME OF PRODUCT IN COMMERCE
14,950 units.
DISTRIBUTION
Canada and the United Kingdom.
_______________________________
PRODUCT
a) Invacare 2G Tarsys Seating System, Model 2GT. Recall #
Z-0342-04;
b) Invacare 2G Tarsys Seating System, Model 2GR. Recall #
Z-0343-04;
c) Invacare 2G Tarsys Seating System, Model 2GTR. Recall #
Z-0344-04.
CODE
a) Serial Numbers: 00Axxx thru 00Lxxx, 01Axxx thru 01Lxxx,
and 02Axxx.
b) Serial Numbers: 00Axxx thru 00Lxxx, 01Axxx thru 01Lxxx,
and 02Axxx.
c) Serial Numbers: 00Axxx thru 00Lxxx, 01Axxx thru 01Lxxx,
and 02Axxx.
RECALLING FIRM/MANUFACTURER
Invacare Corporation, Elyria, OH, by letter and telephone on December 15, 2003. Firm initiated recall is ongoing.
REASON
The weld joints on the seat back may fail and cause possible injury to the patient.
VOLUME OF PRODUCT IN COMMERCE
5,990 units.
DISTRIBUTION
Nationwide, Canada, China, Oman, and West Indies.
_______________________________
PRODUCT
Prostatron is a computer-controlled device designed to
deliver microwave energy to the prostrate for the
treatment of BPH (Benign Prostatic Hyperplasia). The
Prostatron utilizes a transurethral microwave antenna,
with simultaneous urethral cooling, to heat the
prostate. This heating process is regulated through
feedback from a series of temperature sensors.
Recall # Z-0345-04.
CODE
Serial numbers PP80023 through PP80040 and PP037 through PP180.
RECALLING FIRM/MANUFACTURER
Urologix, Inc., Minneapolis, MN, by letter on December 10, 2003. Firm initiated recall is ongoing.
REASON
During treatment the Temperature Sensing System may change the rectal temperature reading by up to 2 degrees celcius and may briefly delay updates to the rectal temperature reading.
VOLUME OF PRODUCT IN COMMERCE
146.
DISTRIBUTION
Nationwide, Australia, France, and Japan.
_______________________________
PRODUCT
Platelia Aspergillus EIA. Recall # Z-0348-04.
CODE
Lot number: 3F0001 Exp. 2004-05-15.
RECALLING FIRM/MANUFACTURER
Bio Rad Laboratories, Inc., Redmond, WA, by letter on November 6, 2003. Firm initiated recall is ongoing.
REASON
Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan.
VOLUME OF PRODUCT IN COMMERCE
147 kits.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H. Recall #
Z-0349-04;
b) Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A,
and B3-1.6a. Recall # Z-0350-04;
c) Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU. Recall
# Z-0351-04;
d) Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and
BS-1.8. Recall #Z-0352-04.
CODE
a) Lot 10830640 (All lot numbers having the last two digits
ending in 40 or 41 and having the year of manufacture
for individual units or sterilization date for cases
from 01 on a unit and 2001 on to case to 03 and 2003.
Expiry year dates are 04 or 2004 to 06 or 2006. An
example date is 01 03 09 on a unit which is read 2001
March 09 and for the case with the same date an example
would be 2001 03 09.);
b) Lot numbers: 10630840, 10230940, and 20230540. (All lot
numbers having the last two digits ending in 40 or 41
and having the year of manufacture for individual units
or sterilization date for cases from 01 on a unit and
2001 on to case to 03 and 2003. Expiry year dates are 04
or 2004 to 06 or 2006. An example date is 01 03 09 on a
unit which is read 2001 March 09 and for the case with
the same date an example would be 2001 03 09.);
c) Lot numbers 10531140, 11230940, 20121440, and 21230140.
(All lot numbers having the last two digits ending in 40
or 41 and having the year of manufacture for individual
units or sterilization date for cases from 01 on a unit
and 2001 on to case to 03 and 2003. Expiry year dates
are 04 or 2004 to 06 or 2006. An example date is 01 03
09 on a unit which is read 2001 March 09 and for the
case with the same date an example would be 2001 03
09.);
d) Lot numbers: 20310140, 20910540, and 20910541. (All lot
numbers having the last two digits ending in 40 or 41
and having the year of manufacture for individual unit
or sterilization date for cases from 01 on a unit and
2001 on to case to 03 and 2003. Expiry year dates are 04
or 2004 to 06 or 2006. An example date is 01 03 09 on a
unit which is read 2001 March 09 and for the case with
the same date an example would be 2001 03 09.).
RECALLING FIRM/MANUFACTURER
Toray Marketing & Sales (America), Inc., Houston, TX, by telephone and letter on January 2, 2004 and January 5, 2004. Firm initiated recall is ongoing.
REASON
Potential loose header (end cap) on hollow fiber dialyzers.
VOLUME OF PRODUCT IN COMMERCE
768 units.
DISTRIBUTION
CA, NJ, FL, TX, OH, WI, NY, and WA.
_______________________________
PRODUCT
ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit
consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2
- 6.0. Recall # Z-0353-04.
CODE
Lots 94493M300 and 94493M301.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated December 15, 2003. Firm initiated recall is ongoing.
REASON
The calibrator lots may yield Free T4 values that are depressed.
VOLUME OF PRODUCT IN COMMERCE
1,364 kits.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Sure Temp Plus Model 690/692 Oral Temperature Probes.
Recall # Z-0354-04.
CODE
Welch Allyn(r) Part #s: 0690-XXX Serial Numbers/Lot Numbers 02692-000 Oral Probe 4 ft. 412003-442003, 472003, 522003-582003. 02692-100 Oral Probe 9 ft. 412003-442003, 472003, 522003-582003 02893-000 Oral Probe Well Kit 4 ft. 412003-442003, 472003, 522003-582003 02893-100 Oral Probe Well Kit 9 ft. 412003-442003, 472003, 522003-582003 Probes are contained in Welch Allyn(r) Thermometer Boxes with Part #s: 0690-XXX Serial Numbers/Lot Numbers 01690-000 03397655 - 03505486 01690-200 03397655 - 03505486 E-01690-200 03397655 - 03505486 01690-300 03397655 - 03505486 01690-400 03397655 - 03505486 01690-410 03397655 - 03505486 01690-500 03397655 - 03505486 E-01692-200 03397655 - 03505486 01692-200 03397655 - 03505486 01692-300 03397655 - 03505486 01692-400 03397655 - 03505486 01692-500 03397655 - 03505486 01692-700 03397655 - 03505486 Probes are contained in Welch Allyn(r) Vital Signs Monitor III boxes with Part Numbers: Serial Numbers/Lot Numbers 53NTO-E1 JA000244, JA000282, JA000283, JA000284, JA000285, JA000286, JA000287, JA000288, JA000289, JA000290, JA000291, JA000292, JA000293, JA000294, JA000295, JA000296, JA000297, JA000298, JA000299, JA000300, JA000301, JA000302, JA000303, JA000304, JA000305, JA000306, JA000307, JA000308, JA000309, JA000310, JA000311, JA000312, JA000313, JA000314, JA000315, JA000316, JA000317, JA000318, JA000319, JA000320, JA000331, JA000332, JA000333, JA000334, JA000335, JA000336, JA000337, JA000340, JA000341, JA000342, JA000343, JA000344, JA000345, JA000347, JA000348, JA000349, JA000352, JA000353, JA000354 53NTP-E1 JA000232, JA000243, JA000246, JA000255, JA000258, JA000259, JA000271, JA000278, JA000281, JA000326, JA000327, JA000328, JA000357.
RECALLING FIRM/MANUFACTURER
Welch Allyn, Inc., San Diego, CA, by letters dated December 29, 2003. Firm initiated recall is ongoing.
REASON
Mechanical setting errors that result in calibration errors.
VOLUME OF PRODUCT IN COMMERCE
4,453.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Abbott Clinical Chemistry AEROSET c8000 Magnesium, List
numbers 7D70-01, 7D70-20, 7D70-30. Recall # Z-0355-04.
CODE
All lots are affected.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Diagnostic Div, South Pasadena, CA, by letters dated December 22, 2003. Firm initiated recall is ongoing.
REASON
Complaints that instructions for use were not clear.
VOLUME OF PRODUCT IN COMMERCE
215.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Autovac TL. Autotransfusion System for Orthopedic Wound
Drainage. Model 7924. The product is shipped in cartons
containing 6 units. Recall # Z-0227-04.
CODE
Lot number 200309 exp. 9/2005.
RECALLING FIRM/MANUFACTURER
Boehringer Laboratories, Inc., Norristown, PA, by field representative visit on November 7, 2003. Firm initiated recall is ongoing.
REASON
Inadequate bond where the tube attaches to the inlet of the bulb.
VOLUME OF PRODUCT IN COMMERCE
273 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
DrugCheck 5, in-vitro diagnostic test for drugs of abuse:
AMP, COC, THC, OPI, MET. Recall # Z-0239-04.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Drug Free Enterprises, Inc., Agoura Hills, CA, by letters in April 2003. FDA initiated recall is complete.
REASON
Lacks professional use labeling and firm name and address.
VOLUME OF PRODUCT IN COMMERCE
2,800.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Arrow A Port with Attachable Silicone Rubber
Catheters/10 Fr. Introducer Kit Implantable Vascular
Access System (Product # AP-06520) Product # AP-06520
kit contains 1 implantable titanium port, 2 attachable
silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x
75 cm), 10 Fr. Introducer kit (spring-wire guide,
introducer needle, sheath), straight non-coring needle,
syringe, tunneling instrument, drape, patient ID card
and chart sticker. Kit sold individually or per case (5
trays/case). Recall # Z-0254-04;
b) Arrow A Port with Attachable Silicone Rubber Catheters
Implantable Vascular Access System (Product # AP-01510).
Product # AP-01510 kit contains 1 implantable titanium
port, 2 attachable silicone rubber catheters (8.4 Fr. x
75 cm and 9.6 Fr x 75 cm) straight non-coring needle,
patient ID card and chart sticker. Kit sold individually
or per case (5 trays/case). Recall # Z-0255-04;
c) Arrow Low Profile Port with Attachable Silicone Rubber
Catheters/10 Fr. Introducer Kit Implantable (Product #
AP-06042) [NB: titanium port]. Product # AP-06042 kit
contains 1 low profile implantable titanium port, 2
attachable silicone rubber catheters (8.4 Fr. x 75 cm
and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire
guide, introducer needle, sheath), injection needle,
syringe, tunneling instrument, drape, patient ID card
and chart sticker. Kit sold individually or per case (5
trays/case). Recall # Z-0256-04;
d) Arrow Low Profile Port with Attachable Silicone Rubber
Catheters/10 Fr. Introducer Kit Implantable Vascular
Access System (Product # AP-06022) [NB: plastic port]
Product # AP-06022 kit contains 1 low profile
implantable plastic port, 2 attachable silicone rubber
catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr.
Introducer kit (spring-wire guide, introducer needle,
sheath), straight non-coring needle, syringe, tunneling
instrument, drape, patient ID card and chart sticker.
Kit sold individually or per case (5 trays/case). Recall
# Z-0257-04.
CODE
a) AP-06520 MF3074927 MF3075118 MF3085217 MF3085281
MF3095491 MF3095574 MF3095611;
b) AP-01510 MF3085292 MF3085315 MF3095551 MF3095651;
c) AP-06042 MF3075086 MF3075140 MF3085285;
d) AP-06022 MF3075080 MF3085227 MF3085410.
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Mount Holly, NJ, by letter on November 4, 2003. Firm initiated recall is ongoing.
REASON
The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.
VOLUME OF PRODUCT IN COMMERCE
913.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Medtronic MiniMed. Model 7311 Solutions Pumps
and Meters Software. Recall # Z-0265-04.
CODE
Version 5.0A.
RECALLING FIRM/MANUFACTURER
Medtronic MiniMed, Northridge, CA, by visit or FedEx software on CD-rom beginning on November 19, 2003. Firm initiated recall is ongoing.
REASON
Accessory software fails to report certain reports following download of data from 712 pump.
VOLUME OF PRODUCT IN COMMERCE
1,020.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) POLYMEDCO ULTRA-CRP High Sensitive Assay For the
DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x
50 Tests. For In Vitro Diagnostic (IVD) use only.
COMMON/USUAL NAME: High-Sensitive C-Reactive Protein ---
CLASSIFICATION NAME: C-reactive Protein, Antigen,
Antiserum. Recall # Z-0295-04;
POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No.
CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the
HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH
SENSITIVE CRP Latex IVD (6 ml). For In Vitro Diagnostic
(IVD) use only. COMMON/USUAL NAME: High-Sensitive C-
Reactive Protein --- CLASSIFICATION NAME: C-reactive
Protein, Antigen, Antiserum. Recall # Z-0296-04.
CODE
a) Lot numbers CP4274-0769M (EXP. 09/04) and CP4335-0812M
(EXP. 11/04);
b) Lot numbers 1155J (EXP. 09/04) and 1388J (EXP. 10/04).
RECALLING FIRM/MANUFACTURER
Polymedco, Inc., Cortlandt Manor, NY, by telephone on December 3, 2003 and by letter on December 5, 2003. Firm initiated recall is ongoing.
REASON
Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications.
VOLUME OF PRODUCT IN COMMERCE
749 lots.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Abbott Commander Flexible Pipetting Center (FPC) Operations
Manual, list 6A97-27; Recall # Z-0297-04.
CODE
All revision numbers, all versions.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letters dated December 2, 2003. FDA initiated recall is ongoing.
REASON
The Operations Manual has the wrong Farenheit temperature range listed (102-122) instead of (104-122) for the preparation of the Terg-A-Zyme solution used to clean pipettes of the Abbott Commander Flexible Pipetting Center.
VOLUME OF PRODUCT IN COMMERCE
Est 380 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750,
REF 192 0115, 100 coated wells per pack.
Recall # Z-0299-04.
CODE
Lot #750, Exp. 14 January 2004.
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letter and e-mail on December 3, 2003. Firm initiated recall is ongoing.
REASON
Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
VOLUME OF PRODUCT IN COMMERCE
524 reagent packs.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Howell D.A.S.H. II Access System, Wire Guided
Sphincterotome. Recall # Z-0301-04.
CODE
Reorder Number: DASH-35-480, Lot Number: W1815864.
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc, Winston Salem, NC, by letter on December 17, 2003. Firm initiated recall is ongoing.
REASON
Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
AZ, CA, MN, NJ, NY, OH, and Egypt.
_______________________________
PRODUCT
Pentalumen TD Thermodilution Catheter, Sterile. Recall #
Z-0305-04.
CODE
List No. 41233-01, Lot 04-187-SN.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter on November 19, 2003. Firm initiated recall is ongoing.
REASON
Thermodilution catheters have a potential for ruptured lumens within the catheter.
VOLUME OF PRODUCT IN COMMERCE
495 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) EndoReturn arterial cannula. The EndoReturn arterial
cannula is indicated for patients undergoing
cardiopulmonary bypass. The EndoReturn cannula with
hemostasis valve allows for hemostatic introduction and
removal of the Heartport EndoClamp aortic catheter.
EndoReturn arterial cannula, 21 Fr. Product code ER21
(07043). The cannulas are also packaged in kits that
have no specific lot number. The EndoReturn arterial
cannula is packaged in the EndoCPB (Cardiopulmonary
Bypass) System with Cardioplegia Catheter, Product codes
ECPB211, 212, 213, 214, 231, 232. Also, the EndoCPB
system without Cardioplegia Catheter, Product codes
ECPB211, 212, 231, 232.Recall # Z-0307-04;
b) EndoReturn arterial cannula. The EndoReturn arterial
cannula is indicated for patients undergoing
cardiopulmonary bypass. The EndoReturn cannula with
hemostasis valve allows for hemostatic introduction and
removal of the Heartport EndoClamp aortic catheter.
EndoReturn arterial cannula, 23 Fr. Product code ER23
(07044). Recall # Z-0308-04;
c) DirectFlow arterial cannula is intended to deliver
oxygenated blood for cardiopulmonary bypass during
surgery. The product also allows the hemostatic
introduction and removal of the Heartport EndoClamp
aortic catheter. DirectFlow arterial cannula, 24Fr,
Product Code DFK24 (06723). The cannulas are also
packaged in kits that have no specific lot numbers
associated. The kits are identified as the ENDODIRECT
System, Product codes ED241, 242, 243, 244. Recall # Z-
0309-04;
d) SoftClamp II arterial cannula is intended to deliver
oxygenated blood for cardiopulmonary bypass during
surgery. The product also allows the hemostatic
introduction and removal of the Heartport EndoClamp-ST
II aortic catheter. SoftClamp II arterial cannula, 24Fr.
SCK (06724). Cannulas are also packaged in kits with no
specific lot numbers associated. The kits is identified
as SoftClamp System, Product Code SC-24.
Recall # Z-0310-04;
e) Introducer Sheath is indicated for patients requiring
introduction of catheters. Introducer Sheath for
EndoClamp, aortic catheter, 19Fr. IS19 (07042).
Recall # Z-0311-04.
CODE
a) Lot Numbers 020349, 050327, 060337;
b) Lot Numbers 020347, 030343, 060338, 080348;
c) Lot Numbers 010367, 020342, 020378, 020379, 020380,
030353, 060358;
d) Lot numbers 030356, 050347, 060359;
e) Lot number 020374.
RECALLING FIRM/MANUFACTURER
Heartport Inc, Somerville, NJ, by telephone on or about October 2, 2003. Firm initiated recall is ongoing.
REASON
Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
VOLUME OF PRODUCT IN COMMERCE
933.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125
Reagent Pack, list 7A89-22; 100 test kits. Recall # Z-
0318-04;
b) Mx CA 125 Mode 1 Calibrator, list 7A89-40; Z-0319-04;
c) CA 125 Calibrators, list 9C22-01; Z-0320-04;
d) AxSYM CA 125 Master Calibrators, list 3B41-30.
Recall # Z-0321-04;
e) CA 125 Controls, list 9C22-10; Recall # Z-0322-04.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated November 25, 2003. FDA initiated recall is ongoing.
REASON
The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the storage conditions, 69-6349/R2, refers to an outdated control package insert, 39-1642/R3, instead of the current control package insert 34-1047/R4.
VOLUME OF PRODUCT IN COMMERCE
Not specified.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each,
supplied with sterile single-use cannula, Rx only.
Recall # Z-0346-04.
CODE
Lots: #5047293 and #5048892.
RECALLING FIRM/MANUFACTURER
Cardinal Health, Groveport, OH, by telephone and letter, on December 11, 2003. Firm initiated recall is complete.
REASON
The product was not held at the labeled storage temperatures, which could affect the product potency and/or physical properties, were distributed.
VOLUME OF PRODUCT IN COMMERCE
110 units.
DISTRIBUTION
OH, and PA.
_______________________________
PRODUCT
Oasis-One Action Stent Introduction System with ST-2
Soehendra Tannenbaum Biliary Stent, (11.5 French size
only), Guiding Catheter: 6 FR, Minimum Accessory Channel
Size: 3.7mm, Wire Guide Sold Separately, Disposable -
Single Use Only, Quality System ISO 9001 Certified, Rx
Only, Recall # Z-0347-04.
CODE
Reorder number: OATS-11.5-5, Lot number: 1637695, 1651258, 1711817, 1713997, W1730838, W1752589, W1817595; Reorder number: OATS-11.5-7, Lot number: 1637696, 1651259, 1711818, 1711819, W1730839, W1738240; Reorder number: OATS-11.5-9, Lot number: 1637697, 1651260, 1702218, 1711820, 1711821, W1738241; Reorder number: OATS-11.5-12, Lot number: 1637694, 1651257, 1683866, W1730837, W1738238, W1752587; Reorder number: OATS-11.5-15 Lot number: 1692178, 1692179, 1711816, W1738239, W1752588.
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc, Winston Salem, NC, by letter on December 19, 2003. Firm initiated recall is ongoing.
REASON
Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm.
VOLUME OF PRODUCT IN COMMERCE
198 units.
DISTRIBUTION
Japan.
END OF ENFORCEMENT REPORT FOR January 21, 2004
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