April 30, 2003
03-18
_______________________________
PRODUCT
Yellow Fin Tuna - Vacuum packaged. Recall # F-331-3.
CODE
The product was uncoded.
RECALLING FIRM/MANUFACTURER
Schneider's Fish & Seafood Corp, Cheektowaga, NY, by telephone, and letter on July 27, 2001. FDA initiated recall is complete.
REASON
Unlabeled product and lack of assurance of proper temperature controls during thawing.
VOLUME OF PRODUCT IN COMMERCE
110 lbs.
DISTRIBUTION
NY.
_______________________________
PRODUCT
Paradise Brand; Cryo-Freeze Tuna Steaks. Recall # F-332-3.
CODE
a) Burris Lot #89892;
b) Burris Lot #87869;
c) Americold Lot #25282.
RECALLING FIRM/MANUFACTURER
Ocean Duke Corporation, Torrance, CA, by email on December 16, 2001, and by telephone and faxed letters on December 18, 2001. Firm initiated recall is complete.
REASON
Vacuum-packaged tuna loins were inadequately labeled resulting in the potential for the formation of C. botulinum toxin due to temperature abuse.
VOLUME OF PRODUCT IN COMMERCE
a) 2,500 cases of 6/8 oz;
b) 3,300 cases of 6/8 oz;
c) 795 cases of 8/10 oz.
DISTRIBUTION
NY, MD, OH, IL, and MA.
_______________________________
PRODUCT
Springfield Smoked Fish Co., Inc. Brand:
Vacum Packed:
a) Smoked Trout Fillets. Various weights 1.22-10.38 lbs.
Recall # F-334-3;
b) Smoked Lemon Peppered Mackerel Fillets.
Various Wts. from 14-10.0 lbs. Recall # F-335-3;
c) Smoked Mackerel Fillets. Various wts. .94-15.15 lbs.
Recall # F-336-3;
d) Smoked Bluefish Fillets. Various wts. from .79-50.01
lbs. Recall # F-337-3;
5 Lb. and 8 oz tubs purchased prior to 3/9/02:
e) Smoked White Fish. Recall # F-338-3;
f) Smoked White Fish Salad. Recall # F-339-3.
CODE
a) Mfg. Code #48;
b) Mfg. Code #47;
c) Mfg. Code #17;
d) Mfg. Code #11;
5 Lb. and 8 oz tubs purchased prior to 3/9/02:
e) Smoked White Fish;
f) Smoked White Fish Salad.
RECALLING FIRM/MANUFACTURER
Springfield Smoked Fish Co., Inc. Springfield, MA, by letter March 15, 2002. Firm initiated recall is complete.
REASON
Products may be underprocessed.
VOLUME OF PRODUCT IN COMMERCE
a) 43.04 lbs;
b) 21.19 lbs;
c) 21.51 lbs;
d) 71.38 lbs;
e) Undetermined;
f) Undetermined.
DISTRIBUTION
MA, CO, and NJ.
_______________________________
PRODUCT
Vacuum packed fish products as follows:
a) Cold Smoked CR King. Recall # F-340-3;
b) Cold Smoked Bellies. Recall # F-341-3;
c) Cold Smoked Trim. Recall # F-342-3;
d) CR King Lox Sides. Recall # F-343-3;
e) Cold Smoked Nova Lox. Recall # F-344-3;
f) Cold Smoked Nova Side. Recall # F-345-3;
g) King Salmon Lox Sides. Recall # F-346-3;
h) Cold Smoked Portions. Recall # F-347-3;
i) Cold Smoked Lox KS. Recall # F-348-3.
CODE
All products on the market during the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Smoki Foods, Inc., Seattle, WA, by telephone and letter on August 20, 2002, and by another letter on August 22, 2002.
FDA initiated recall is complete.
REASON
The products may not have adequate water phase salt levels resulting in the potential for C. botulinum toxin formation.
VOLUME OF PRODUCT IN COMMERCE
13,441 lbs.
DISTRIBUTION
WA, and HI.
______________________________
PRODUCT
Ancom tablets, Anti-hypertensive Compound Tablets, 100 count bottle. The exterior holding carton is labeled in a similar manner with a paper insert labeled in part as --Ancom tablet is a complex preparation consisting of anti-hypertensive agents such as rauwolfia alkaloid, dihydralazine sulphate, together with sedative, diuretic, blood-potassium equilibrium salt, etc. Each tablet contains: Reserpine 0.032 mg, Potassium Chloride 30 mg, Hydrochlorothiazide 3.1 mg, Vitamin B1 1 mg, Diazepam 1 mg, Promethiazine HCL 2.1 mg, Dihydralazine Sulphate 4.2 mg, Calcium pantothenate 1 mg, Magnesium Trisilicate 30 mg, Vitamin B6. The bottle, unit carton & insert are labeled both in English and Chinese. Recall # D-233-3.
CODE
All lot codes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Herbsland Incorporated, New York, NY, by visit, on November 22, 2002.
Manufacturer: Shanghai Pharmaceutical Industry Corp. Shanghai, China. FDA initiated recall is complete.
REASON
Unapproved new drug labeled to contain several prescription drug ingredients, including reserpine, diazepam, promethiazine, and hydrochlorothiazide.
VOLUME OF PRODUCT IN COMMERCE
300 bottles.
DISTRIBUTION
NY.
______________________________
PRODUCT
Ancom tablets, Anti-hypertensive Compound Tablets, 100 count bottle. The exterior
holding carton is labeled in a similar manner with a paper insert labeled in
part as --Ancom tablet is a complex preparation consisting of anti-hypertensive
agents such as rauwolfia alkaloid, dihydralazine sulphate, together with sedative,
diuretic, blood-potassium equilibrium salt, etc. Each tablet contains: Reserpine
0.032 mg, Potassium Chloride 30 mg, Hydrochlorothiazide 3.1 mg, Vitamin B1 1
mg, Diazepam 1 mg, Promethiazine HCL 2.1 mg, Dihydralazine Sulphate 4.2 mg,
Calcium pantothenate 1 mg, Magnesium Trisilicate 30 mg, Vitamin B6. The bottle,
unit carton & insert are labeled both in English and Chinese. Recall # D-234-3.
CODE
All lot codes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Best Life International, Incorporated, Mayaguez, PR, by letter,
on February 11, 2003.
Manufacturer: Shanghai Pharmaceutical Industry Corp. Shanghai, China. FDA initiated
recall is ongoing.
REASON
Unapproved New Drug containing several prescription ingredients.
VOLUME OF PRODUCT IN COMMERCE
591 bottles.
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Betamethasone Repository Injection, 6 mg/mL, 2, 5 and
10mL glass vials, Rx. Recall # D-227-3;
b) Betamethasone Repository (PF) Injection, 6 mg/mL, 2, 5
and 10mL glass vials, Rx. Recall # D-228-3.
CODE
a) Lot Number: 12102002@11, 09172002@1, 10012002@5,
10212002@10, 10282002@8, 11162002@1, 11262002@6,
12192002@19, 01022003@23, 01072003@12, 01102003@3,
01162003@7;
b) Lot Numbers: 01022003@24, 01282003@1.
RECALLING FIRM/MANUFACTURER
New England Compounding Center, Framingham, MA, by telephone on February 21, 2003, and letters on February 28, 2003. Firm initiated recall is ongoing.
REASON
Subpotent.
VOLUME OF PRODUCT IN COMMERCE
a) 4,362 vials;
b) 479 vials.
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Necon 0.5/35 Tablets (norethindrone 0.5mg and ethinyl estradiol 35mcg), 6 tablet dispensers, 28 tablets each, Rx only. Recall # D-185-3.
CODE
Lot 50701D00, Exp April 2003.
RECALLING FIRM/MANUFACTURER
Watson Diagnostics, Inc, by letter on January 9, 2003. Firm initiated recall is ongoing.
REASON
Impurities; product exceeds total impurities specification (stability).
VOLUME OF PRODUCT IN COMMERCE
6,366 cartons.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Methylprednisolone AC (PF) Injection, 80mg/mL,
1 ml vial, Rx only. Recall # D-215-3;
b) Methylprednisolone AC (PF) Injection, 40mg/mL,
1 mL vial, Rx only. Recall # D-217-3.
CODE
a) Lot Codes: 04172002@7, 04112002@8, 03282002@10,
03122002@12, 02272002@8, 02132002@1, 02052002@6
04292002@5, 05072002@17, 05192002@15, 05232002@3
05312002@16, 07042002@2;
b) Lot codes: 04182002@1, 06032002@16.
RECALLING FIRM/MANUFACTURER
New England Compounding Center, Framingham, MA, by telephone between July 2002 and August 2002. Firm initiated recall is complete.
REASON
Product labeled with incorrect expiration date.
VOLUME OF PRODUCT IN COMMERCE
a) 9,551 - 1mL vials;
b) 861 - 1 mL.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Allegra Tablets, 60/120mg, 60 count bottles, Rx only.
Recall # D-220-3.
CODE
Lot # 3B1250BA EXP 5/2004 Lot # 3B1250BB EXP 5/2004.
RECALLING FIRM/MANUFACTURER
Recall by: Direct Dispensing, Inc., Miami, FL, by telephone on March 26, 3003, and by letters on April 3, 2003.
Manufactured by: Aventis Pharmaceuticals, Kansas City, MO.
Firm initiated recall is ongoing.
REASON
Mislabeled (by repacker); bottle labeled to contain Allegra actually contains Allegra-D (fexofenadine/pseudoephedrine HCl).
VOLUME OF PRODUCT IN COMMERCE
56 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Carisoprodol Tablets, USP, 350mg, 500 and 1000 tablet bottles. Recall # D-221-3.
CODE
1,000 tablet bottles -- 210049A exp. 9/04;
210050A exp. 9/04;
500 tablet bottles -- 210051A exp. 9/04;
210052A exp. 9/04; 210053A exp 10/04.
RECALLING FIRM/MANUFACTURER
Able Laboratories, Inc., South Plainfield, NJ, by letter dated January 15, 2003. Firm initiated recall is ongoing.
REASON
Incorrect tablet imprinting; some tablets bear the incorrect identification "A265" rather than "A266".
VOLUME OF PRODUCT IN COMMERCE
7,731 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Premarin Tablets (Conjugated Estrogens Tablets, USP) 1.25 mg, 100 count bottles, Rx Only. Recall # D-229-3.
CODE
1D00076, Exp. 08/03.
RECALLING FIRM/MANUFACTURER
Recalled by: Amerisource Health Services, Corp., Columbus, OH, by recall notices on April 3, 2003.
Manufacturer: Ayerst Laboratories Inc., A Wyeth-Ayerst Company, Philadelphia, PA. Firm initiated recall is ongoing.
REASON
Dissolution failure (by manufacturer).
VOLUME OF PRODUCT IN COMMERCE
449 bottles of 100 tablets.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Blood-Pack_ Units with PL 732 Transfer Pack.
Recall # B-0672-3.
CODE
Product Code 4R3431NM: Lots M03A09014, M03A09014A.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation/Fenwal Division, Deerfield, IL,
by letter dated March 17, 2003.
Manufacturer: Baxter Healthcare Corporation/Fenwal Division, Maricao, Puerto
Rico. Firm initiated recall is ongoing.
REASON
PL732 Platelet Containers that may split during component preparation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 lots, 16,890 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Platelets. Recall # B-0784-3.
CODE
Unit number F52894.
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Bank, Springfield, IL, by facsimile on November 12, 2002. Firm initiated recall is complete.
REASON
Blood product collected from a donor that did not answer one of the history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0807-3.
CODE
Unit number 03K21952.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on September 30, 2002, and by letter on October 18, 2002. Firm initiated recall is complete.
REASON
Blood product collected from a donor that did not answer one of the history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0808-3.
CODE
Unit number 18N83004.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by letter dated January 20, 2003. Firm initiated recall is complete.
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
MI.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0809-3.
CODE
Unit number 18FX38619.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by letter dated July 29, 2002.Firm initiated recall is complete.
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
MI.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0810-3;
b) Platelets. Recall # B-0811-3;
c) Plasma, Cryoprecipitate Reduced. Recall # B-0812-3;
d) Fresh Frozen Plasma. Recall # B-0813-3;
e) Platelets for further manufacture. Recall # B-0814-3;
f) Recovered Plasma. Recall # B-0815-3.
CODE
a) Unit numbers 18FQ74621, 18FQ74622, 18FQ74631, 18FQ74634,
18FQ74635, 18FQ74636, 18FQ74643, 18FQ74645, 18FQ74646,
18FQ74647, 18FQ74648, 18FQ74651, 18FQ74652, 18FQ74653,
18FQ74655, 18FQ74656, 18FQ74658, 18FQ74659, 18FQ74661,
18FQ74662, 18FQ74666, 18FQ74669, 18FQ74671, 18FQ74673,
and 18FQ74674;
b) Unit numbers 18FQ74611, 18FQ74614, 18FQ74615, 18FQ74616,
18FQ74618, 18FQ74624, 18FQ74628, 18FQ74633, 18FQ74636,
18FQ74637, 18FQ74639, 18FQ74640, and 18FQ74641;
c) Unit numbers 18FQ74643, 18FQ74646, 18FQ74647, 18FQ74666
18FQ74667, and 18FQ74674;
d) Unit numbers 18FQ74628 and 18FQ74651;
e) Unit numbers 18FQ74617, 18FQ74619, 18FQ74623, and
18FQ74634.
f) Unit numbers 18FQ74616, 18FQ74642, 18FQ74648, 18FQ74650,
18FQ74653, 18FQ74654, 18FQ74655, 18FQ74658, 18FQ74660,
18FQ74661, 18FQ74663, and 18FQ74664.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone, facsimile, and letter between January 10 and 17, 2002, an additional notification on May 1, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose health history screening were inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 25 units;
b) 13 units;
c) 6 units;
d) 2 units;
e) 4 units;
f) 12 units;
DISTRIBUTION
MI, CA, MA, and Switzerland.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0786-3.
CODE
Unit KC77022.
RECALLING FIRM/MANUFACTURER
BloodSource, Sacramento, CA, by telephone on March 11, 2002. Firm initiated
recall is complete.
REASON
Blood product, that did not have the additive solution included within the time
frames specified by the manufacturer's instructions, was distributed.
VOLUME
OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
______________________________
PRODUCT
Heat Exchanger Coil used in the "Custom Cardiovascular Procedure Kits". Recall
# Z-0298-3.
CODE
TCVS Product code number 0006-00011; all coils in custom cardiovascular procedure
kits within their labeled shelf life of 24 months (i.e. kits made 12/1/2000 to
10/25/2002) as follows: Procedure Kit Codes Produced in Lot # 63182-02 CA02 70035;
8539TX CA07 62973; 63153;63688-01; 8539TX CA14 63688-01 CA14T 62973 CA28 8539TX
CC04 63688-01; 8525T CC11 63688-01 CC11T 63688-01 CC11TR 62786; 62973;63432; 70060;
63688-01 CC18 63688-01 CC18T 63323-02; 63153 CC25 62336-01; 7957-02; 8525T CD04
63323-02 CD11 70035 ;8539TX; CD18 63182-02; 8525T CD25 62417-03; 62973-01; 63182-02;
63688-01 CE01 63688-01 CE01R 62973-01; 63688-01 CE01T 70187; 62786 CE08 70017;
62973-01 ;63182-02; 63688-01 CE15 63182-02; 63688-01 CE15T 63688-01 CE15TR 70001;
63182-02 CE22 63323-02 CE29 63432; 62336-01; 63079-01; 8525T; 63070-01; 63182-02
CF06 131246-01; 63014-01; 63688-01 CF13 63688-01 CF13R 63688-01 CF13T 70001; 63182-02
CF20 63323-02 CF28 63064 ;62336-01; 62544-01 CG03 63153; 70035; 62973-01 CG10
63064; 62417-03; 62973-01; 63688-01 CG17 63064 CG17R 63079-01; 63688-01 CG24 62336-01
CH01 62786; 63432;62973-01; 63688-01 CH08 62973-01 CH08T 70035; 63323-03; 63688-01
CH15 70001; 63688-01; 63182-02 CH22 63688-01 CH22T 63064; 70001; 70251; 131246-01;
63014-01 CH29 64130; 62544-01; 62973-01 CK05 64130 CK12 64130 CK12T 64130; 63079-01
CK19 63014-01; 63323-03 CK26 70085 CL03 62973-01; 8539TXC CL09 64203; 62973-01;
63064-01 CL16 70413; 8525T CL23 63298 YP04 62417-03 YP11 62336-01 YP18 63014;
8539TX ZA08 62973 ;8539TX ZA22 62973; 63079 ZA29 63432 ZC05 62973; 63014; 63432;
62513-01 ZC12 63014; 63079; 63298; 62973 ZC19 63153 ;63315; 63432; 62361-02; 62513-01
ZC26 62513-01 ZC26T 62786; 63315; 63323 ZD05 63064; 63323; 62544-01; 8525T; 62513-01
ZD12 62361-02; 62544-01; 63323 ZD19 63014 ;8539T; 62786 ZD26 62786; 63315 ZE02
63014; 63064; 63432; 8525T ZE09 63153; 62544-01; 63323 ZE16 62973 ;63323 ZE23
63014 ZE30 63064; 62417-03 ZF07 63064 ZF07R 62786; 63153 ZF14 62544-01; 8539TX
ZF21 8539TX ZF21T 8539TX ZF21TR 62973; 63014; 63298 ZF29 62973; 63432; 63315-01
ZG04 62973; 8539TX ZG11 63323; 63079-01 ZG18 63323 ZG18T 62973; 63070; 63432;
62417-03; 63315-01 ZG25 63688; 70001; 63315-01; 8335TX ZH09 62973; 63688; 63079-01;
63153 ZH16 63688; 70001; 62336-01; 8525T ZH23 63688; 70001 ZH23T 63688; 63726;
8539TX ZH30 63688 ZH30R 63688 ZK06 63688 ZK06T 70012 ZK20 63014 ZK20R 70012 ZK20T
62786; 63079-01; 8525T; 8539TX ZK27 8539TX ZK27R 62786; 62973; 63014; 62417-03;
63323-01 ZL04 63014 ZL04R 62973 ZL04T 63014 ZL10 63014 ZL10T 8539TX; 8525T ZL17
62544-01; 63323-01; 8525T ZL24 63323-01 ZL24T 70073 ZM08 62786 ZM15 62786; 62417-03;
8525T ZM22 63014; 63688; 70085; 62336-01; ZM29 70085 ZM29R 62973; 63153; 63432;
63688 ZN05 62973 ZN05T 62973 ZN05TR 8539TX ZN12 8525T ZN19 62417-03; 62544-01
ZN26 62336-01 ;8525T; 63182-02 ZP03 8525T; 63182-02 ZP03T 63064; 63751;63815 ZP10
70106; 63182-02 ZP17.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems, Corporation, Ashland, MA, by telephone, fax and
letter on November 8, 2002. Firm initiated recall is ongoing.
REASON
Heat exchanger may contain loose particulate matter.
VOLUME OF PRODUCT IN COMMERCE
10,035.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Biosound Caris Plus Ultrasound System with phased array probes, model 7230;
Biosound Megas Ultrasound System with phased array probes, model 7250. Recall
# Z-0299-03.
CODE
All Caris Plus units with PA220, PA121, PA122, PA023 or PA230 probes;
All Megas units with PA122 or PA023 probes.
RECALLING FIRM/MANUFACTURER
Biosound Esaote, Inc., Indianapolis, IN, by service upgrade notices, on or about
January 22, 2003. Firm initiated recall is ongoing.
REASON
Excessive power output due to a faulty voltage controller.
VOLUME OF PRODUCT IN COMMERCE
157 Caris Plus systems;
503 Megas.
DISTRIBUTION
Nationwide and Canada.
______________________________
PRODUCT
Sedecal High Voltage Generators and Sedecal Controls. Recall # Z-0649-03.
CODE
Model Number:
US Distributed -
SHF210 (6); SHF310 (70); SHF310RF (2);
SHF310LS (3); SHF310AEC (1); SHF310PSU (3); SHF320 (30);
SHF320F (1); SHF320RF (1); SHF320LS (1); SHF330 (5);
SHF410 (7); SHF410RF (1); SHF420 (4); SHF420RF(2);
SHF430RF (1); SHF510 (5); SHF510LS (2); SHF520 (4);
SHF520RF (3); SHF520LS (1); SHF525RF (2); SHF530 (1);
SHF530LS (1); SHF535 (4); SHF625 (1); SHF630 (3);
SHF630RF (2); SHF635 (1); SHF835 (2); SHF835RF(2).
Foreign Distributed -
SHF310 (9); SHF315 (1); SHF320 (6); SHF320RF(2);
SHF320-CE(4); SHF330 (1); SHF410 (1); SHF420RF(1);
SHF520 (1); SHF630 (1).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sedecal US, Inc, Arlington Heights, IL, by telephone, and letter on April 9, 2003.
Manufacturer: Sedecal SA, Madrid, Spain. Firm initiated recall is ongoing.
REASON
An incorrect identification label and the failure of the certification testing program resulted in Generators and High Voltage Controls not complying with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE
199 units.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
Sedecal Mobile X-Ray System. Recall # Z-0650-03/Z-0651-03.
CODE
Model Numbers: SM20H and SM30H.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sedecal US, Inc, Arlington Heights, IL, by telephone, and letter on April 9, 2003.
Manufacturer: Sedecal SA, Madrid, Spain. Firm initiated recall is ongoing.
REASON
An incorrect identification label and the failure of the certification testing program resulted in the Mobile Systems not complying with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
Nationwide and Germany.
______________________________
PRODUCT
Sedecal URS X-Ray System. Recall # Z-0652-03.
CODE
Model Number: URS.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sedecal US, Inc, Arlington Heights, IL, by letter on April 9, 2003.
Manufacturer: Sedecal SA, Madrid, Spain. Firm initiated recall is ongoing.
REASON
An incorrect identification label and the failure of the certification testing program resulted in the Sedecal URS X-Ray Systems not complying with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
NY, TX, FL, and MN.
______________________________
PRODUCT
Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased array probes, model 7250. Recall # Z-0708-03.
CODE
All Caris Plus units with PA220, PA121, PA122, PA023 or PA230 probes. All Megas units with PA122 or PA023 probes.
RECALLING FIRM/MANUFACTURER
Deroyal Surgical-Rose Hill, Rose Hill, VA, by certified mail on February 25, 2003. Firm initiated recall is ongoing.
REASON
Non-sterile surgical medical device is labeled as sterile product.
VOLUME OF PRODUCT IN COMMERCE
216 units.
DISTRIBUTION
PA, TX, WA, AR, HI, CA, and TN.
______________________________
PRODUCT
Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936. Recall # Z-0709-03.
CODE
Lot numbers: 262111 (manufactured June 2002, expires May 2005); 282233 (manufactured August 2002, expires July 2005).
RECALLING FIRM/MANUFACTURER
I-Flow Corporation, Lake Forest, CA, by fax on March 5, 2003, and email on March 6, 2003. Firm initiated recall is ongoing.
REASON
Wrong component may result in over infusion of medications.
VOLUME OF PRODUCT IN COMMERCE
5,808 units.
DISTRIBUTION
NY, MA, and Internationally.
______________________________
PRODUCT
Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250. Recall # Z-0711-03.
CODE
Lot number 5140999.
RECALLING FIRM/MANUFACTURER
Boston Scientific Scimed, Maple Grove, MN, by letter dated March 20, 2003. Firm initiated recall is ongoing.
REASON
The product units in the recalled lot are in pouches which may have incomplete seals that could lead to compromised sterility.
VOLUME OF PRODUCT IN COMMERCE
31 stents.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) Multi Absorbers, reference number 8003138.
Recall # Z-0713-03;
b) Multi Absorbers, reference number 8003138, in S/5
Aespire Start-up Kits (each containing 2 Multi
Absorbers). Recall # Z-0714-03.
CODE
a) Lot numbers 728112 and 798122;
b) Lot numbers 728112 and 798122 of the Multi Absorbers
in the kits.
RECALLING FIRM/MANUFACTURER
Datex-Ohmeda, Madison, WI, by letters dated February 12, 2003. Firm initiated recall is ongoing.
REASON
Multi Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.
VOLUME OF PRODUCT IN COMMERCE
a)167 cases (6 Multi Absorbers per case);
b) 5 S/5 Aespire Start-up kits.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) Accu-Chek Comfort Curve glucose test strips;
part numbers 2030420, 2030365, 2030373, 2030381, 3000133
and 3000141. Recall # Z-0715-03;
b) Accu-Chek Advantage glucose test strips;
part numbers 336, 556, 787 and 966. Recall # Z-0716-03.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, by letters dated February 12, 2003. Firm initiated recall is ongoing.
REASON
Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.
VOLUME OF PRODUCT IN COMMERCE
10,600,000 vials.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec. Recall # Z-0717-03.
CODE
Units under recall include the following serial numbers: 3582 thru 3681, 3685 thru 3733, 3739 thru 3766, 3768, 3800 thru 3809.
RECALLING FIRM/MANUFACTURER
Linvatec Corp., DBA Linvatec/Hal, Largo, FL., by telephone and letter beginning on January 24, 2003. Firm initiated recall is ongoing.
REASON
The Footswitch functions of the left and right foot pedals may be reversed in some units.
VOLUME OF PRODUCT IN COMMERCE
74 units.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
CryoValve Allograft, Heart Valve. Recall # Z-0719-03.
CODE
Aortic Valve & Conduit, Donor #29976, Serial #6212891, Model #AV00 and Pulmonary Valve & Conduit Donor #51562, Serial #7093095, Model #PV00.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by telephone on February 24, 2003, and by letter on March 6, 2003. Firm initiated recall is ongoing.
REASON
Pre-processing cultures detected certain microorganisms in donor tissue.
VOLUME OF PRODUCT IN COMMERCE
2 individual heart valve allografts.
DISTRIBUTION
OH and Canada.
______________________________
PRODUCT
CoaguChek PT test strips, sold in 12 pack.
Recall # Z-0720-03.
CODE
Lot 533.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, by letter in February, 2003. Firm initiated recall is ongoing.
REASON
Discrepancy between INR and the % Quick displayed on the meter.
VOLUME OF PRODUCT IN COMMERCE
11,412.
DISTRIBUTION
Germany.
______________________________
PRODUCT
a) CryoValve Heart-valve, allograft. Recall # Z-0722-03;
b) CryoValve Heart-valve, allograft. Recall # Z-0723-03.
CODE
a) Aortic Valve & Conduit, Donor #34695, Serial #6356206,
Model #AV00 and Pulmonary Valve & Conduit, Donor #34695,
Serial #6356214, Model #PV00;
b) Aortic Valve & Conduit, Donor #34695, Serial #6356206,
Model #AV00 and Pulmonary Valve & Conduit, Donor #34695,
Serial #6356214, Model #PV00.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on March 19, 2003. Firm initiated recall is ongoing.
REASON
The recipient of one of the kidneys from the donor has developed renal cell carcinoma.
VOLUME OF PRODUCT IN COMMERCE
2 allografts.
DISTRIBUTION
NY and MS.
______________________________
PRODUCT
Aeroset Software versions 1.00ER005, catalog number 2-89996-01; and software version 1,00ER005.2, catalog number 2-89996-02. Recall # Z-0725-03.
CODE
No codes.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on February 24, 2003. Firm initiated recall is ongoing.
REASON
Under certain operating conditions, smart wash feature disables with multiple samples.
VOLUME OF PRODUCT IN COMMERCE
645 units.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, B - 15, C - 50, D - 100, E - 200 and F - 350. Recall # Z-0726-03.
CODE
Lot number 89651M300, exp. 04/20/03.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter dated March 4, 2003. Firm initiated recall is ongoing.
REASON
The Imx AFP Calibrators may cause depressed values for the Imx AFP Low Control, and cause patient results to be 20% lower than actual values.
VOLUME OF PRODUCT IN COMMERCE
107 kits.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) High Performance Sodasorb Carbon Dioxide Absorbent,
Diving Grade(18%) Soda Lime USP-NF with an ethyl violet
indicator which turns from white to violet as absorber
is depleted; the product is packaged in 5-gallon pails
under the W.R. Grace label. Recall # Z-0730-03;
b) Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%)
Soda Lime USP-NF with an ethyl violet indicator which
turns from white to violet as absorber is depleted;
the product is packaged in pre-packs(pre-filled 2.5 lb.
canisters, 12 per carton), canister packs (pre-measured
2.5 lb. bags, 12 per carton), 5-gallon pails and 55-
gallon drums under the W.R. Grace label and the Portex
label. Recall # Z-0731-03.
CODE
a) Lot numbers CP01-P124-01, CP01-P124-02, CP01-P124-04 and CP01-P124-05;
b) Lot numbers CN12-P115-02, CN12-P115-03, CN12-P115-04,
CN12-P115-05, CN12-P115-07, CN12-P115-08, CN12-P115-09,
CN12-P115-10, CN12-P115-11, CN12-P115-12, CN12-P115-13,
CN12-P115-14, CP01-P115-01, CP01-P115-02, CP01-P115-03,
CP01-P115-04, CP01-P115-05, CP01-P115-08, CP01-P115-10,
CP01-P115-11, CP01-P115-12, CP01-P115-15, CP01-P115-16,
CP01-P115-17, CP01-P115-18, CP01-P115-19, CP01-P115-20,
CP01-P115-21, CP01-P115-22 and CP01-P115-23.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Darex Container Products, Div of W. R. Grace & Co, Chicago, IL, by letter dated February 11, 2003.
Manufactured by: W.R. Grace & Company, Chicago, IL. Firm initiated recall is ongoing.
REASON
Contaminated with epoxy chips.
VOLUME OF PRODUCT IN COMMERCE
a) 32,232 pre-packs; 50,748 canister packs;
1,400 5 gallon pails; 49 55 gallon drums.
b) 591 5 gallon pails.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with
Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric
Leg Strap, Contents Sterile. Recall # Z-0732-03.
CODE
Catalogue #150719, 150732, 150819, 150832,
Lot numbers beginning with 76JL through 76BN.
RECALLING FIRM/MANUFACTURER
C. R. Bard, Inc., Urological Division, Covington, GA, by letter on March 25, 2003. Firm initiated recall is ongoing.
REASON
There is a potential for package seals to b open after sterilization.
VOLUME OF PRODUCT IN COMMERCE
283, 277 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Finger Joint Implants, Silicone Models
a) TRL-10 and b) TRL-20. Recall # Z-0710-03.
CODE
a) Lot 45275002;
b) Lot 45186001.
RECALLING FIRM/MANUFACTURER
Avanta Orthopaedics, Inc., San Diego, CA, by telephone on January 24, 2003.
Firm initiated recall is complete.
REASON
Wrong silicone elastomer used in construction.
VOLUME OF PRODUCT IN COMMERCE
a) 13 units;
b) 30 units.
DISTRIBUTION
CA, UT, and France.
______________________________
PRODUCT
3 M Attest Steam Pack 1276F (biological indicator of steam sterilization for
use at hospitals). Recall # Z-0779-03.
CODE
Lot 2330-06 AE.
RECALLING FIRM/MANUFACTURER
3m Health Care, Saint Paul, MN, by letter on January 8, 2002. Firm initiated
recall is complete.
REASON
Some 3M Attest Steam Packs 1276F (biological indicator challenge for steam sterilization)
were labeled as 3M Attest Rapid Readout Steam Pack 1296F.
VOLUME OF PRODUCT IN COMMERCE
666 cases (25 Steam Pack per case).
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR APRIL 30, 2003
###
Office of Public Affairs
Hypertext created by clb 2003-APR-30.