April 9, 2003
03-15
_____________________________
PRODUCT
Sweetened Coconut, Ing sugar coconut, 6 oz packages of dried coconut pieces, Product of China. Recall # F-266-3.
CODE
Code No. 30.06.2004.
RECALLING FIRM/MANUFACTURER
Summit Import Corp., Jersey City, NJ, by press release on February 4, 2003, by telephone on February 6, 2003 and by letters on February 14, 2003. State initiated recall is complete.
REASON
The product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
20 cases x 50/6 oz packages. Approximately 1000 packages.
DISTRIBUTION
CT, IL, MA, MD, NY, OH, PA, VA, and Washington D.C.
_____________________________
PRODUCT
Premium Sara Lee Signature Selections Deep Dish Fruits of the Forest Pie, Net Wt 40 oz., packaged 6/9-inch pies per case in cases labeled Premium Sara Lee Signature Selections Caramel Applenut Pie, frozen for later baking.
Recall # F-286-3.
CODE
06032242XX (xx=hour of the day which range from 00-23).
RECALLING FIRM/MANUFACTURER
Sara Lee Bakery Group, Inc., St. Louis, MO, by fax and press release on December 23, 2002. Firm initiated recall is complete.
REASON
Caramel Applenut Pie containing walnuts was packaged in Fruits of the Forest Pie cartons that do not list walnuts as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
6,327/6-pie cases.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Sun-dried tomatoes, net. Wt 3 oz. packed in plastic clam shell container and 5 lb plastic bags. Recall # F-294-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Maurice A. Auerbach, Inc., South Hackensack, NJ, by press release on January 17, 2003,by telephone on January 24, 2003 and by letter on January 28, 2003. State initiated recall is ongoing.
REASON
The sun-dried tomatoes contain undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
1142 lbs.
DISTRIBUTION
CT, NY, NJ, PA, RI and MA.
_____________________________
PRODUCT
Ruggles brand Vanilla Ice Cream, No Sugar Added, Reduced Fat, packaged in half-gallon cartons. Recall # F-295-3.
CODE
The retail containers are coded: "336 2".
RECALLING FIRM/MANUFACTURER
Smith Dairy Products, Co., Orrville, OH, by telephone and letter on January 30, 2003 and January 31, 2003 and by press release on January 30, 2003. Firm initiated recall is ongoing.
REASON
The cartons actually contain Butter Pecan Ice Cream and pecans are not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
4,248 cartons.
DISTRIBUTION
OH, KY, IN, PA, and WV.
_____________________________
PRODUCT
Mini-cup gel candies containing konjac sold under three brands - Grand Western, My Love, and Hocean.
Flavors are as follows:
a) Lychee. Recall # F-324-3;
b) Longan. Recall # F-325-3;
c) Taro. Recall # F-326-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Grand Western (USA) Trading, Inc., Commerce, CA, by press release on February 1, 2002 and by letter on February 2, 2002.
Manufacturer: Jojomo Enterprise Co. LTD, Hua-Tan Hsiang, Chang-Hua Twiw. FDA initiated recall is complete.
REASON
This type of candy is in violation of section 402 (a) (3) of the Federal Food, Drug and Cosmetic Act in that it is unfit for food due to the characteristics that result in a serious choking hazard.
VOLUME OF PRODUCT IN COMMERCE
226 cases.
DISTRIBUTION
CA and TX.
_____________________________
PRODUCT
a) Lisy Mini-Jelly candies, all flavors, sealed in clear
plastic bags, 6 sealed cups per bag. Recall # F-327-3;
b) Lisy dulcecitos assorted candies, 1.50 oz bag. The bag
may contain one or two minigel cups (konjac) of "ABC
Mini-Fruit Bites" per bag along with other assorted
candies. Recall # F-328-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Lisy Corp., Miami, FL, by letters on January 14, 2002, and March 6, 2002. FDA initiated recall is complete.
REASON
This type of candy is in violation of section 402 (a) (3) of the Federal Food, Drug and Cosmetic Act in that it is unfit for food due to the characteristics that result in a serious choking hazard.
VOLUME OF PRODUCT IN COMMERCE
a) 1,323 cases of 72 packs/6 candies each;
b) 1,000 cases of the assorted dulcecitos product.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
12 and 24 count cartons of Mug Root Beer containing 12 oz. cans. Some cartons contained cans labeled as Diet Mug Root Beer that were filled with regular Mug Root Beer.
Recall # F-258-3.
CODE
XXXXMC02043 1 Expiration: AUG 11 03.
RECALLING FIRM/MANUFACTURER
Pepsi Bottling Group, Inc., Somers, NY, by pepsi drivers starting on February 14, 2003. Firm initiated recall is complete.
REASON
Some cans labeled as Died Mug Root Beer actually contained regular Mug Root Beer.
VOLUME OF PRODUCT IN COMMERCE
8,592 cases.
DISTRIBUTION
MN and WI.
_____________________________
PRODUCT
Wrap Arounds brand Spinach Tortilla, extra large in plastic bags, 19.26 oz. net wt. Recall # F-285-3.
CODE
UPC CODE # 78858-02261, Lot #'s SELL BY 363 01-31-03;
003 02-05-03; 007 02-09-03; 009 02-11-03; 016 21-18-03;
026 02-28-03; 027 03-01-03.
RECALLING FIRM/MANUFACTURER
La Tortilla Factory, Inc., Santa Rosa, CA, via letter on February 4, 2003. FDA initiated recall is ongoing.
REASON
The product contains undeclared colors, FD&C Yellow No. 5, FD&C Blue No. 1, and FD&C Red No. 40.
VOLUME OF PRODUCT IN COMMERCE
1,527 units.
DISTRIBUTION
CA.
_____________________________
PRODUCT
a) Nestle Brand Cracker -- Ricas Galletas Finas Saladas,
net. Wt. 240gm. Recall # F-318-3;
b) Nestle Brand Cookies -- Galletas DeCoco, net wt. 450gm.
Recall # F-319-3.
CODE
a) Lot # FAB20JUN2002C EXPDIC2002 Exp. 12/2002;
b) Lot # 21-06-2002-3 Exp. 4/2003.
RECALLING FIRM/MANUFACTURER
Triunfo Import & Export Corp., Newark, NJ, via telephone on November 8, 2002. State initiated recall is complete.
REASON
The products do not bear English labeling and contain ingredients such as wheat.
VOLUME OF PRODUCT IN COMMERCE
a) 87 cases x 24 boxes;
b) 99 cases x 40 boxes.
DISTRIBUTION
NY and NJ.
_____________________________
PRODUCT
Captain's Catch Crab Meat, 16 oz (454 g) can. Hand picked and pasteurized. Product of Vietnam. Recall # F-329-3.
CODE
Can Codes: 2291E1, 2273K1, 2276B1, 2269K1.
Additional lot: 2299E1.
RECALLING FIRM/MANUFACTURER
Seawise Inc., Portsmouth, NH, by letter on February 14, 2003. The firm recalled an additional code, lot # 2299E1 on March 20, 2003. Firm initiated recall is ongoing.
REASON
Crab meat is contaminated with chloramphenicol.
VOLUME OF PRODUCT IN COMMERCE
90 cases (12 cans/cs).
DISTRIBUTION
FL, MA, NJ, NY, PA, and VA.
_____________________________
PRODUCT
a) Methylprednisolone Acetate Injection, 40mg/mL P.F.,
Preservative Free, Single Dose Vial, sold in 1ml, 2ml,
5ml, or 10ml vials. Recall # D-197-3;
b) Methylprednisolone Acetate Injection, 80mg/mL,
Preservative Free, Single Use Vial, sold in 1ml, 2ml,
5ml, or 10ml vials. Recall # D-198-3.
CODE
a) 28022002:03 02012002:56 24012002:95 05022002:11
21022002:91 04042002:29 01052002:01 07052002:06
09052002:33 14082002:59 19092002:45;
b) 4667:47A, 4667:47B, 4667:47C : 02012002:30 22012002:71
29012002:38 08022002:79 13022002:59 16022002:12
22022002:89 28022002:09 12032002:39 19032002:09
04042002:32 30042002:35 07052002:20 09052002:75
14052002:70 03062002:58 20062002:32 06082002:46
22082002:37 03092002:79 23092002:29 4651:14
4750:65 4775:88.
RECALLING FIRM/MANUFACTURER
Lee Pharmacy, Inc., Fort Smith, AR, by letters dated December 24, 2002 and December 30, 2002. Firm initiated recall is ongoing.
REASON
a) Microbial contamination;
b) Fungal contamination (Cladosporium).
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
a) Betamethasone Injection Repository P.F. 6mg,
Preservative Free, Single Dose Vial, sold in 1ml, 2 ml,
5ml, or 10ml vials. Recall # D-201-3;
b) Betamethasone Sodium Phosphate Injection, Preservative
Free, 12mg/mL, Single Dose Vial, sold in 1ml, 2 ml,
5ml, or 10ml vials. Recall # D-202-3;
c) Bupivacaine 0.25% Injection, Preservative Free, Single
Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
Recall # D-203-3;
d) Clonidine Hydrochloride Injection, 100mg, Preservative
Free, Single Dose Vial, Lee Pharmacy, Inc., 4300 Grand
Avenue, Fort Smith, AR 72904, sold in 1ml, 2 ml, 5ml, or
10ml vials. Recall # D-204-3.
e) Co-Enzyme Q-10 Injection, Preservative Free, Single Dose
Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
Recall # D-205-3;
f) EDTA 150 mg/ml injection, 100 ml, Preservative Free.
Recall # D-206-3;
g) Hyaluronidase 150U/ml injection, Preservative Free,
Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
Recall # D-207-3.
h) Sodium Chloride 23.4% Injection, Preservative Free,
Single Dose, sold in 1ml, 2 ml, 5ml, or 10ml vials.
Recall # D-208-3;
i) Sodium Chloride 10% Injection, Preservative Free, Single
Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
Recall # D-209-3;
j) Sodium Chloride 3% Injection, Preservative Free,
Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
Recall #B-210-3.
k) Triamcinolone Acetonide Injection, 40mg/ml P.F.,
Preservative Free, Single Dose Vial, sold in 1ml, 2 ml,
5ml, or 10ml vials. Recall # D-211-3;
l) Triamcinolone Diacetate,40 mg/ml P.F., Preservative
Free, Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml
Vials. Recall # D-212-3;
m) Betamethasone LA-SA, Injection, 12mg/ml, Preservative
Free, Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml
Vials. Recall # D-213-3.
CODE
a) 19022002:71; 20022002:02; 02042002:65; 14052002:50;
21052002:19; 10062002:14; 09072002:20; 29072002:12;
30072002:22; 20082002:27; 09092002:81; 4642:76; 4678:46;
4706:40; 4755:77; 4786:27; 4831:25; 4850:25;
11032002:24; 4848:35; 02072002:23;
b) 13062002:46; 27082002:15; 4722:37; 4702:55; and 4721:33;
c) 23012002:98 02042002:40 12062002:79 22082002:45 4742:96;
d) 14082002:42 20092002:39 4663:40;
e) 15022002:08;
f) 21082002:24 4645:62 4761:84;
g) 22082002:88 16092002:28;
h) 4746:25;
i) 4714:50;
j) 4690:43;
k) 20062002 25042002:64 03062002:38 02072002:58 02082002:31
27082002:21 09092002:88 4737:75;
l) 05022002:48 11022002:43 11032002:55 21032002:41
15042002:44 25042002:54 20052002:71 29052002:19
30052002:54;
m) 14052002:65.
RECALLING FIRM/MANUFACTURER
Lee Pharmacy, Inc., Fort Smith, AR, by letters dated December 24, 2002 and December
30, 2002. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Betamethasone LA-SA 6mg/mL Multi-Dose Vial, Not for
IV Administration, Use By 11/03. Recall # D-199-3.
b) Betamethasone SA-LA 6mg/ml P.F., 5mL Single Dose Vial,
Preservative Free, Not for IV Administration, Use
By 11-03. Recall # D-200-3.
CODE
a) Lot 4785:43A;
b) Lot 4786:27B.
RECALLING FIRM/MANUFACTURER
Lee Pharmacy, Inc., Fort Smith, AR, by telephone on December 20, 2002. Firm initiated recall is ongoing.
REASON
Subpotent; betamethasone acetate.
VOLUME OF PRODUCT IN COMMERCE
722 vials.
DISTRIBUTION
Nationwide.
___________________________
PRODUCT
Fetal Cell Stain Kit No. S0412-00, contents include 3 x 120ml Fetal Cell Fixing
Solution (80% Reagent Alcohol), 3 x 120ml Fetal Cell Citrate Buffer Solution
(Citrate Buffer, 0.081M), and 3 x 120ml Fetal Cell Stain (Erythrosin-B, Fast
Green). Recall # Z-0653-03.
CODE
Lot #92558, Exp. March, 2004.
RECALLING FIRM/MANUFACTURER
Simmler, Inc., St Louis, MO, by letters dated December 12, 2002 and mailed on
December 18, 2002. FDA initiated recall is ongoing.
REASON
Fixing solution bottles are labeled as buffering solution.
VOLUME OF PRODUCT IN COMMERCE
352 kits.
DISTRIBUTION
Nationwide, Canada, and Japan.
___________________________
PRODUCT
a) Digene's Hybrid Capture 2 HPV DNA Test, Catalog # 5101-
1096. Recall # Z-0654-03;
b) Digene's Hybrid Capture 2 HPV DNA Test, Catalog # 5196-
1230, labeled for export only. Recall # Z-0655-03;
c) Hybrid Capture 2 high-Risk HPV DNA Test, Catalog # 5101-
1296. Recall # Z-0656-03;
d) Hybrid Capture II CT-ID Twst, Catalog # 5135-10501VT,
(labeled for export only). Recall # Z-0657-03;
CODE
a) Lot 2447/exp 2004-01; Lot 2476/exp 2003-08-14;
Lot 2569/exp 2003-09-24; Lot 2570/exp 2003-11;
Lot 2577/exp 2003-09-24; Lot 2646/exp 2003-08;
b) Lot 2759/exp 2003-08-31;
c) Lot 2436/exp 2003-11;
d) Lot 2443/exp 2002-12-02.
RECALLING FIRM/MANUFACTURER
Digene Corp., Gaithersburg, MD, by telephone and fax on February 7, 2003. Firm
initiated recall is ongoing.
REASON
In Vitro diagnostic test kit may produce false positive patient results.
VOLUME OF PRODUCT IN COMMERCE
a) 1,858 kits/96 assays per kit;
b) 848 kits/96 assays per kit;
c) 831 kits/96 assays per kit;
d) 272 kits/96 assays per kit.
DISTRIBUTION
Nationwide and Internationally.
___________________________
PRODUCT
Flexgard, off-the-shelf knee brace, product number 14761106. Recall # Z-0658-03.
CODE
Lot numbers 53078 and 53985.
RECALLING FIRM/MANUFACTURER
DeRoyal Industries, San Luis Obispo, CA, by letter dated February 19, 2003.
Firm initiated recall is ongoing.
REASON
Manufacturing defect possibly causing screws to come loose causing the brace
to collapse during use.
VOLUME OF PRODUCT IN COMMERCE
13.
DISTRIBUTION
ID, CA, NC, TX, SC, NM, GA, and TN.
___________________________
PRODUCT
TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016. Recall # Z-0659-03.
CODE
Lot 32688.
RECALLING FIRM/MANUFACTURER
Interpore Cross International, Inc., Irvine, CA, by telephone on February 7,
2003. Firm initiated recall is ongoing.
REASON
Instrument fell apart during cleaning prior to surgery.
VOLUME OF PRODUCT IN COMMERCE
39.
DISTRIBUTION
Nationwide and Internationally.
___________________________
PRODUCT
a) Baxter SPS 550 Single Patient System Hemodialysis
Machine. Recall # Z-0660-03;
b) Baxter 1550 Single Patient System Hemodialysis Machines.
Recall # Z-0661-03.
CODE
a) Catalog numbers: 5M1309, 5M1309R, 5M1310, 5M1310R,
5M5506, 5M5506R, 5M5507, 5M5507R, 5M5516, 5M5516R,
5M5518, 5M5518R, 5M5533, 5M5536, FM4649, FM4654, FM4714,
FM4796R, FM4797; all serial numbers;
b) Catalog numbers: 5M5538, 5M5538R, 5M5551, 5M5551R,
5M5575, FM4719, FM4774, FM4779, FM4779R; all serial
numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated February
20, 2003.
Manufacturer: Baxter Healthcare Corp., Deerfield, IL. Firm initiated recall
is ongoing.
REASON
Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration
via adjustment of transmembrane pressure (TMP).
VOLUME OF PRODUCT IN COMMERCE
17,322 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Product is labeled as "Oto-Flex Bur", Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows: Part Number 31-55631 Oto-Flex carbide 1.0mm Bur;
Part Number 31-55632 Oto-Flex carbide 2.3mm Bur;
Part Number 31-55642 Oto-Flex diamond 2.3mm Bur;
Part Number 31-55647 Oto-Flex diamone 0.7 mm Bur.
Part Number and Lot Number is listed on pouch and box label. Recall # Z-0662-03.
CODE
Part No. 31-55631, lot number 27066500
Part No. 31-55632, lot number 27111700
Part No. 31-55642, lot number 27135800
Part No. 31-55647, lot number 27123300.
RECALLING FIRM/MANUFACTURER
Medtronic Xomed, Inc., Jacksonville, FL, by letter on January 25, 2003. Firm initiated recall is ongoing.
REASON
Product packaging pouches may be open thereby compromising the sterile barrier.
VOLUME OF PRODUCT IN COMMERCE
120.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K. Recall # Z-0663-03.
CODE
FD1268 thru FD1282.
RECALLING FIRM/MANUFACTURER
Curon Medical, Inc., Sunnyvale, CA., by letters on February 21, 2003. Firm initiated recall is ongoing.
REASON
Catheter shaft has potential to crack during use.
VOLUME OF PRODUCT IN COMMERCE
326 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Sarns MP4 Cardioplegia Sets; catalog number 15501. Recall # Z-0664-03.
CODE
Lot 322125.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp.
REASON
There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.
VOLUME OF PRODUCT IN COMMERCE
300.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Misys Laboratory System Version 5.3. Recall # Z-0670-03.
CODE
Version 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on February 19, 2003. Firm initiated recall is ongoing.
REASON
Software anomaly. The HIDE command used to suppress suspected individual microbiology observations does not work in GUI inquiry.
VOLUME OF PRODUCT IN COMMERCE
464.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Permobil Chairman 2K powered wheelchair, Model 1280.
Recall # Z-0671-03.
CODE
Serial Numbers: 1100068 to 1103702.
RECALLING FIRM/MANUFACTURER
Permobile, Inc., Lebanon, TN, by letter with repair kit on March 10, 2003. Firm initiated recall is ongoing.
REASON
Incidents were reported where a drive wheel has come off its motor axle, due either to loosening of the wheel bolt or a broken wheel bolt.
VOLUME OF PRODUCT IN COMMERCE
1582.
DISTRIBUTION
Nationwide, Puerto Rico, and Canada.
____________________________
PRODUCT
CryoValve Allograph, Heart valve. Recall # Z-0672-03.
CODE
Donor #60084, Serial #7769926, Model #PV00 and
Donor #55139, Serial #7165235, Model #SGPV00.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc.,Kennesaw, GA, by telephone on February 4, 2003 and February 24, 2003, and by letter on February 25, 2003. Firm initiated recall is ongoing.
REASON
Microorganisms were detected in distributed allografts.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OK, British Columbia, and Canada.
_____________________________
PRODUCT
CryoValve Allograft, heart valve. Recall # Z-0673-03.
CODE
Donor #61266, Serial # 7701969, Model #AV00;
Donor #63307, Serial #7899279, Model # SGAV00;
Donor #64489, Serial #7869356, Model # SGPV00;
Donor #65674, Serial # 7957300 Model #SGPV00;
Donor #64879, Serial # 7883273, Model #SGPV00;
Donor #64697, Serial #7876274, Model #PV00.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on/about February 20, 2003. Firm initiated recall is ongoing.
REASON
Microorganisms were detected in distributed donor tissue.
VOLUME OF PRODUCT IN COMMERCE
6.
DISTRIBUTION
CA, MD, ME, and SD.
_____________________________
PRODUCT
ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following
PET (Positron Emission Tomography) systems:
Recall # Z-0674-03.
CODE
All serial numbers of above indicated scanner models using ECAT System Software
Versions V7.1.1b, V7.2, V7.2.1 and V7.2.2.
RECALLING FIRM/MANUFACTURER
Cti Pet Systems, Inc., Knoxville, TN, by letter beginning on March 4, 2003.
Firm initiated recall is ongoing.
REASON
Incorrect patient information is displayed in the reconstructed images of a
whole body patient scan.
VOLUME OF PRODUCT IN COMMERCE
444.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
CryoValve Allograft heart valve. Recall # Z-0675-03.
CODE
Model number SGPV00, Serial Number: 7291867, Donor #55899.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by telephone on/about January 23, 2003, and on site visit on January 30, 2003. Firm initiated recall is complete.
REASON
An allograft associated with this donor has been linked to an alleged infection.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
_____________________________
PRODUCT
CryoValve Allograft heart valve. Recall # Z-0676-03.
CODE
Model number PV00, Serial Number: 7255205, Donor #56190.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by telephone on/about January 23, 2003, and on site visit on January 30, 2003. Firm initiated recall is complete.
REASON
An allograft associated with this donor has been linked to an alleged infection.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
_____________________________
PRODUCT
One heart and pericardium. Recall # Z-0677-03.
CODE
Donor # 12144.
RECALLING FIRM/MANUFACTURER
DCI Donor Services Tissue Services Division, Nashville, TN, by memorandum on August 20, 2002. Firm initiated recall is complete.
REASON
Human tissue was procured from donor using non-sterile instruments.
VOLUME OF PRODUCT IN COMMERCE
1 heart and pericardium.
DISTRIBUTION
GA.
_____________________________
PRODUCT
Misys Laboratory, Calculator Data processing Module for Clinical Use. Recall # Z-0678-03.
CODE
Version 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ., by fax on January 17, 2003. Firm initiated recall is ongoing.
REASON
Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol.
VOLUME OF PRODUCT IN COMMERCE
520.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
a) Abbott AxSYM CA 15-3 Master Calibrator Pack,
list 3B42-30; the pack contains two 4-mL bottles, with
Master Calibrator 1 having 0 U/mL and Master Calibrator
2 having 60 U/mL. Recall # Z-0679-03;
b) CA 15-3 Calibrators, list 9C08-01; the pack contains six
4-mL bottles of 115D8:DF3 reactive determinants
prediluted in TRIS buffer with protein stabilizers to
yield the following assay values: A - 0 u/mL, B - 15
U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F -
250 U/mL. Recall # Z-0680-03;
c) IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent
pack contains two 4-mL bottle of Mode 1 Calibrator along
with other reagents. Recall # Z-0681-03;
CODE
a) List 3B42-50, lot 86504M300;
b) List 9C08-01, lot 88127M100;
c) List 6A75-22, lot 90843M200.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD, Abbott Park, IL., by letter dated March 4, 2003. Firm initiated recall is ongoing.
REASON
The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
VOLUME OF PRODUCT IN COMMERCE
a) 958 packs
b) 792 packs;
c) 409 packs.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Tarsys 1st Generation Seating System - an optional accessory for the Powered Wheelchairs. Recall # Z-0682-03.
CODE
All model numbers (excluding the 2nd generation models); Serial numbers 931 through 02E.
RECALLING FIRM/MANUFACTURER
Invacare Corp.,Elyria, OH, by letters on March 10, 2003. Firm initiated recall is ongoing.
REASON
A short circuit within the charger harness may cause heat damage to the units with potential for fire.
VOLUME OF PRODUCT IN COMMERCE
20,956.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
LTX Endosseous Implant 6.0 mm x 11.5 mm and also
LTX Endosseous Implant 5.0 mm X 15 mm, Sterile.
Recall # Z-0665-03.
CODE
For LTX 611 lot number 150102P for LTX 515 lot number 150100P.
RECALLING FIRM/MANUFACTURER
Implant Innovations, Inc., Palm Beach Gardens, FL, by fax on January 28, 2003. Firm initiated recall is ongoing.
REASON
Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size.
VOLUME OF PRODUCT IN COMMERCE
68.
DISTRIBUTION
Brazil, Korea, Taiwan and Chile.
_____________________________
PRODUCT
Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box.
Recall # Z-0666-03.
CODE
Pouch codes for the 180 cm length guidewires are: Catalog No. 46-591, UPN M001465910 Lot Number Use Before Date 4959940 2005-08 4959941 4969651 4969654 4969655 4969656.
The pouch codes for the 260 cm length guidewires are: Catalog No. 46-5912, UPN M001465920 Lot Number Use Before Date 4959945 2005-08 4959946 4959944 4959943.
RECALLING FIRM/MANUFACTURER
Symbiosis, Corp., Miami, FL, by letter on November 27, 2002. Firm initiated recall is ongoing.
REASON
The 180 cm guidewire is mislabeled as 260 cm. The 260 cm guidewire is mislabeled as 180 cm.
VOLUME OF PRODUCT IN COMMERCE
286 3-pack boxes.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
X-ray, computed Tomography, Model TSX101A.
Recall # Z-0668-03.
CODE
None.
RECALLING FIRM/MANUFACTURER
Toshiba American Med Systems, Inc., Tustin, CA, by letters on February 12, and February 13, 2002. Firm initiated recall is ongoing.
REASON
Misassembly can cause fire.
VOLUME OF PRODUCT IN COMMERCE
68
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645. Recall # Z-0669-03.
CODE
All instruments with version 2A or higher.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by telephone and letters from January 27, 2003 to February 3, 2003. Firm initiated recall is ongoing.
REASON
Incorrect Hemoglobin result can be reported at software version 2A and higher.
VOLUME OF PRODUCT IN COMMERCE
234.
DISTRIBUTION
Nationwide and Canada.
_____________________________
PRODUCT
a) Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size
configuration: 1 mL glass ampule shipped 10 ampules
per case. Recall # Z-0683-03;
b) Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size
configuration: 1 mL glass ampule shipped 10 ampules per
case. Recall # Z-0684-03;
c) Papanicolaou Stain EA-50. Product size configurations:
1L, 4L, and 10L. Recall # Z-0685-03.
CODE
a) Item # 68996/95 Lot #1295; Exp. Date April 30,2004;
b) Item #68988/95; Lot #2330; Exp. Date May 31, 2005;
c) Item Nos. 7062X/75, 7062X/85, and 7062X/86. Lot #2255
Exp. Date September 30, 2004;
RECALLING FIRM/MANUFACTURER
EMD Chemicals, Inc., Gibbstown, NJ, by telephone and letter on December 17, 2002, January 24, 2003, January 28, 2003, and February 4, 2003. FDA initiated recall is ongoing.
REASON
a) The Ethanol Standard is OOS on the high end. The
results were 1.58 mg/mL while the specification is
1.477-1.538 mg/mL;
b) The Ethanol Standard is OOS on the low end. The
results were 0.44 mg/mL while the specification is
0.48-0.52 mg/mL;
c) Difficulty in reading slides due to the stain is
much greener than normal.
VOLUME OF PRODUCT IN COMMERCE
a) 279 cases of 10 ampules;
b) 139 cases of 10 ampules;
c) 232 bottles.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Access 2 Immunoassay System. Recall # Z-0692-03;
b) Access 2 Immunoassay side of Lxi 725.
Recall # Z-0693-03.
CODE
All fielded instruments.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters dated January 30, 2003, and February 5, 2003. Firm initiated recall is ongoing.
REASON
False results from secondary pour off tubes.
VOLUME OF PRODUCT IN COMMERCE
a) 718;
b) 10.
DISTRIBUTION
Nationwide and Canada.
_____________________________
PRODUCT
a) Cidex Solution Test Strips Browne GA Indicators for
Cidex Solution Test Strips. Recall # Z-0694-03;
b) Cidex Plus Solution Test Strips. Recall # Z-0695-03.
CODE
a) Cidex Activated, Product Code 2920 lots: 7840 7739 8064
8503 8422 8661 8771 8923 9188 9313 9414 Cidex Plus,
Product Code 2924, lots: 8423 8560 9229 Cidex Plus,
Product code 2926, lots: 8312 8658 9120 Cidex Activated,
Product code 2927, lots: 7783 8160 8182 8604 8790 9317
9404;
b) Cidex Activated, Product Code 2920 lots: 7840 7739 8064
8503 8422 8661 8771 8923 9188 9313 9414 Cidex Plus,
Product Code 2924, lots: 8423 8560 9229 Cidex Plus,
Product code 2926, lots: 8312 8658 9120 Cidex Activated,
Product code 2927, lots: 7783 8160 8182 8604 8790 9317
9404.
RECALLING FIRM/MANUFACTURER
Advanced Sterilization Products, Irvine, CA, by emails and letters between February 14, 2003 and February 27, 2003. Firm initiated recall is ongoing.
REASON
Test strips which are used for QC of sterilant solution fail due to ingress of moisture.
VOLUME OF PRODUCT IN COMMERCE
33,039 cases.
DISTRIBUTION
Nationwide and Internationally.
END OF ENFORCEMENT REPORT FOR APRIL 9, 2003
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