June 4, 2003
03-23
_______________________________
PRODUCT
a) Harmony Farms brand "Gourmet Salad Sprouts" in 5 oz. plastic clam
shell containers. Product consists of alfalfa, sweetpea, lentil
& broccoli sprouts. Recall # F-381-3;
b) Harmony Farms brand sprouts "Fresh Alfalfa & Oregon Onion Sprouts"
in 5 oz plastic clam shell container. Product consists of alfalfa
and Oregon onion sprouts. Recall # F-382-3;
c) Alfalfa sprouts - Harmony Farms brand "Fresh Alfalfa Sprouts"
in 5 oz plastic clamshell containers, and "ALFALFA SPROUTS" in
1 lb., 2 lb., 3 lb., and 5 lb. plastic covered plastic trays.
Recall # F-383-3.
CODE
BEST BY: APR 04 and prior dates.
RECALLING FIRM/MANUFACTURER
Harmony Farms, Auburn, WA, by press release, telephone, and letter on March 15, 2003. Oregon State initiated recall is complete.
REASON
Product has been epidemiologically linked to illnesses of Salmonella serotype Saintpaul.
VOLUME OF PRODUCT IN COMMERCE
@ 8,000 lbs./week.
DISTRIBUTION
WA. OR, AK, and ID.
_______________________________
PRODUCT
Australian Yellowtail Kingfish (cryovac hamachi loins). Each vacuum pack of the fresh fillets had various weights ranging from 1 kg to 2 kg. The individual vacuum packs are shipped in Styrofoam shipping containers with weights ranging from 25 lbs to 35 lbs. Recall # F-384-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: E. Frank Hopkins Co., Inc., Philadelphia, PA, by letters on November 5, 2002.
Manufacturer: Clean Seas Aquaculture Growout Pty, Ltd, Port Lincoln, South Australia. FDA initiated recall is complete.
REASON
The product was inadequately labeled resulting in the potential for the formation of Clostridium botulinum toxin due to temperature abuse.
VOLUME OF PRODUCT IN COMMERCE
64.84 lbs.
DISTRIBUTION
PA and NJ.
_______________________________
PRODUCT
Product is labeled as Mother Kitchen, 50 oz., Tri-Variety (Fudge Swirl, Strawberry Swirl, Classic) Gourment Cheesecake. Recall # F-388-3.
CODE
UPC code 24916-98686; code date 02331.
RECALLING FIRM/MANUFACTURER
Mothers Kitchen, Inc., Burlington, NJ, via telephone, and e-mail on April 4, 2003, and by letters on April 22, 2003. Firm initiated recall is ongoing.
REASON
Mispackaged; the almond portion cheesecake was packaged in a box that had no almond declaration.
VOLUME OF PRODUCT IN COMMERCE
5,220 cakes.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Granite State Artesian Water, 1 gallon plastic jug.
Recall # F-389-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Turner's Dairy, Inc., Salem, NH, by telephone on July 11, 2002. State initiated recall is complete.
REASON
Bottled water was contaminated with coliforms.
VOLUME OF PRODUCT IN COMMERCE
750 gallons.
DISTRIBUTION
NH and MA.
_______________________________
PRODUCT
Criollo Crema Latina Nata (Latin Cream),packaged in a clear plastic container; Net wt. 16oz. Recall # F-390-3.
CODE
All product with incomplete ingredient statement is under recall.
RECALLING FIRM/MANUFACTURER
Cardonic, Corp., Miami, FL, by store visit beginning on April 10, 2003. FDA initiated recall is ongoing.
REASON
Latin cream contains undeclared milk, whey, and other non-allergenic ingredients.
VOLUME OF PRODUCT IN COMMERCE
2,398/16 oz. bottles.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Mytussin AC Cough Syrup, MGP, (Guaifenesin, USP 100 mg and Codeine Phosphate, USP 10 mg per (5mL) each teaspoon), Sugar-Free, NET: 4 fl oz (118mL), 1 Pint (473mL) and 1 Gallon (3785mL) bottles. Also sold under the following brand name in each container size - Robafen AC Cough Syrup. Recall # D-261-3.
CODE
Lots 24071, 24195, 24337, 24421, 24423, 24492, 24535, 24541, 24591, 24650,24683, 24741, 24071A, 24071E.
RECALLING FIRM/MANUFACTURER
Morton Grove Pharmaceuticals, Inc., Morton Grove, IL, by letters on May 9, 2003. Firm initiated recall is ongoing.
REASON
Subpotent (codeine phosphate-18 month Stability test).
VOLUME OF PRODUCT IN COMMERCE
226,850 - 4 oz; 275,680 - 16 oz; 3,357 - 128 oz bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Senokot Granules (standardized senna concentrate), Natural Vegetable Laxative, 15mg sennosides in each teaspoon, 6 oz and 12 oz bottles. Recall # D-262-3.
CODE
Lot No. RR61 exp. 10/2007; RA02 exp. 10/2007; RA11 exp. 10/2007.
RECALLING FIRM/MANUFACTURER
The Purdue Frederick Company, Stamford, CT, by telephone on April 15, 2003, and by letters on April 25, 2003. Firm initiated recall is ongoing.
REASON
Mold contamination-Inactive ingredient-Malt syrup lot used in granule manufacturing had expired and was later found to contain surface mold.
VOLUME OF PRODUCT IN COMMERCE
4,296 - 6oz. bottles; 2,419 - 12 oz. bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Premarin Tablets (conjugated estrogens tablets, USP), 0.625 mg,
100 tablet unit dose packages;
100 tablet bottles; and 5,000 tablet bottles. Rx only.
Recall # D-263-3;
b) Premphase Tablets, 0.625 mg/5 mg (conjugated estrogens 0.625 mg
and medroxyprogesterone acetate 5 mg tablets), Ez-dial dispenser
containing 28 tablets, Rx only. Recall # D-264-3.
CODE
a) Lot #s: A09049 exp. April 2004 (100-tablet bottles);
A09041 exp. April 2004 (5,000-tablet bottles);
A09067 exp. April 2004 (100-tablet unit dose packages);
b) Lot #s: A09065 Exp. 11/03; A12270 Exp. 12/03; A09069, Exp. 12/03.
RECALLING FIRM/MANUFACTURER
Robins Division of Wyeth, Richmond, VA, by letters on/about May 16, 2003. Firm initiated recall is ongoing.
REASON
Dissolution failure; 18 month stability station-2 hour time point.
VOLUME OF PRODUCT IN COMMERCE
111,605 units.
DISTRIBUTION
Nationwide.
___________________________
PRODUCT
Red Blood Cells. Recall # B-1019-3.
CODE
Unit number 0147668.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on February 18, 2002. Firm initiated
recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
________________________________
PRODUCT
Red Blood Cells. Recall # B-1020-3.
CODE
Unit number 0161448.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on May 30, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
________________________________
PRODUCT
a) Platelets. Recall # B-1030-3;
b) Cryoprecipitated AHF. Recall # B-1031-3;
c) Fresh Frozen Plasma. Recall # B-1032-3.
CODE
a) and c) Unit number 7506170;
b) Unit number 7618557.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated June 22, 2001. 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
3 units.
DISTRIBUTION
TX.
________________________________
PRODUCT
a) Platelets. Recall # B-1036-3;
b) Fresh Frozen Plasma. Recall # B-1037-3.
CODE
a) and b) Unit number 5379485.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated September 25, 2001. Firm initiated recall is complete.
REASON
Blood products, manufactured from a unit of Whole Blood that had a discrepant collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
________________________________
PRODUCT
a) Red Blood Cells. Recall # B-1038-3;
b) Platelets. Recall # B-1039-3.
CODE
a) and b) Unit number 5358384.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated June 22, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of colitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and MI.
______________________________
PRODUCT
Cornea. Recall # B-1044-3.
CODE
ID number 03-097-1
RECALLING FIRM/MANUFACTURER
Utah Lions Eye Bank, Salt Lake City, UT, by telephone and by letter on March 20, 2003. Firm initiated recall is complete.
REASON
Cornea that was collected from a donor who was found to test repeatedly reactive for Hepatitis B Core antibody (HBcAb) subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
UT.
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1047-3;
b) Cryoprecipitated AHF. Recall # B-1048-3.
CODE
a) and b) 50LG75346.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone on September 5, 2002, and by letter dated September 13, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units,
DISTRIBUTION
OH, and IN.
________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1049-3;
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1050-3.
CODE
a) Unit numbers 20030-0136, 20407-7092, 21608-4302;
b) Unit number 17199-2305.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by telephone on September 24, 2002, and by letter dated October 15, 2002. Firm initiated recall is complete.
REASON
Blood products, possibly exposed due unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Source Plasma. Recall # B-1065-3.
CODE
Unit numbers G-15328-113, and DLG004449.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Beaumont, TX, by letter on November 19, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was documented as unacceptable, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KY, and CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1066-3.
CODE
Unit number DLG005475.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Beaumont, TX, by facsimile on October 30, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was documented as unacceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
_______________________________
PRODUCT
Source Plasma. Recall # B-1067-3.
CODE
Unit number DLG012653.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Beaumont, TX, by facsimile on December 9, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
_______________________________
PRODUCT
Source Plasma. Recall # B-1068-3.
CODE
Unit number WSG007612.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on January 27, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
_______________________________
PRODUCT
Source Plasma. Recall # B-1069-3.
CODE
Unit number WSG007388.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 1, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
________________________
PRODUCT
a) Portex 1st Response Adult Manual Resuscitators REF 8506P,
expandable tube reservoir, peep valve. Recall # Z-0808-03;
b) Portex 1st Response Adult Manual Resuscitators REF 8500P,
Bag Reservoir, peep valve. Recall # Z-0809-03;
c) Portex 1st Response Adult Manual Resuscitators REF 8503P,
40" tube reservoir. Recall # Z-0810-03.
CODE
a) Lot #'s 020624, 020705, 021003, 200205, 200214, 200216;
b) Lot #'s 020607, 020620, 020622, 020703, 020710, 020829,
200214, 200215, 200216;
c) Lot #'s 020624, 020702, 020917, 021003, 200205, 200214, 200216.
RECALLING FIRM/MANUFACTURER
Sims Portex, Inc., Keene, NH, by telephone on November 15, 2002, and November
18, 2002, and by letter dated November 19, 2002. Firm initiated recall is ongoing.
REASON
Peep valve set at the highest level and could result in patient injury.
VOLUME OF PRODUCT IN COMMERCE
10,416 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Aeroset Analyzer, item 9D05-01. Recall # Z-0843-03.
CODE
All units on the market prior to 12/3/2001.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on October 2, 2001. Firm initiated
recall is ongoing.
REASON
Extensive use of cuvettes causes inaccurate results. Preventative maintenance
did not specify replacement schedule.
VOLUME OF PRODUCT IN COMMERCE
238 units.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
Aeroset Analyzer. Recall # Z-0844-03.
CODE
All Aeroset devices distributed prior to 08/15/2002.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by Technical Service Bulletins dated
August 15, 2002, and by letter on August 20, 2002. Firm initiated recall is
ongoing.
REASON
Design of high concentration waste line causes formation of a precipitate in
the waste line causing overflow of waste.
VOLUME OF PRODUCT IN COMMERCE
578 units.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
a) GEM Premier 3000 Pak pH, pC02, p02, Hct Sensor and Reagent
Cartridge Part No. 24330004 (300 Sample Size) For In-Vitro
Diagnostic Use. Recall # Z-0845-03;
b) GEM Premier 3000 Pak Sensor pH, pC02, p02, Hct and Reagent
Cartridge Part No. 24345004 (450 Sample Size) For In-Vitro
Diagnostic Use. Recall # Z-0846-03;
CODE
a) Lot Number: 306355 Expires: 8/31/2003;
b) Lot Number: 306360 Expires: 8/31/2003.
RECALLING FIRM/MANUFACTURER
Instrumentation Laboratory, Co., Lexington, MA, by telephone on March 7, 2003.
Firm initiated recall is complete.
REASON
Incorrect bar code applied to cartridges could result in inaccurate p02 value.
VOLUME OF PRODUCT IN COMMERCE
18 cartridges.
DISTRIBUTION
CA, FL, NY, PA, and TN.
_____________________________
PRODUCT
a) "Hello Kitty", Plaque Removing Powered Toothbrush, Model HK70W.
Recall # Z-0847-03;
b) "NASCAR", Electric Powered Toothbrush, Model NC70.
Recall # Z-0848-03.
RECALLING FIRM/MANUFACTURER
Gimelli No: 7625.006; Emerson #: HK70W;
Gimelli No: 7625.005; Emerson #: NC70.
REASON
Powered toothbrushes are exploding due to gas build-up.
VOLUME OF PRODUCT IN COMMERCE
24,564 brushes.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) Nutriline with Peelable Sheath 2 Fr. Peripherally inserted
Catheter (PIC). Included with this catheter is a 2 Fr. Insertion
sheath. Product is packaged in tyvek sealed plastic tray.
Recall # Z-0849-03.
b) Neonatal Catheter & Insertion Tray is a catheter kit that
is comprised of the Nutriline Peelable Sheath 2 Fr. Catheter and
a separately packaged catheter tray. Recall # Z-0850-03.
CODE
a) Lot #B01A48 Exp. 11/2007;
b) Lot #31203MA Exp. 7/1/2005.
RECALLING FIRM/MANUFACTURER
Vygon Corporation, East Rutherford, NJ, by letters, via e-mails and telephone
on April 9, 2003. Firm initiated recall is complete.
REASON
Nutriline with Peelable Sheath 2 Fr. And Neonatal Catheter & Insertion Tray
were packaged with a 3 Fr. Insertion sheath.
VOLUME OF PRODUCT IN COMMERCE
71.
DISTRIBUTION
MA, NY, GA, FL, OH, CO, and CA.
______________________________
PRODUCT
Gent-L-Kare Sterile Mid-Stream Urine Collector. Recall # Z-0859-03.
Gent-L-Kare Sterile 3OZ. Ear/Ulcer Bulb Syringe Single Use.
Recall # Z-0860-03.
CODE
Catalog # 4150, Lot number 037667A2.
Catalog # 4173, Lot number 038594A1.
RECALLING FIRM/MANUFACTURER
Medegen Medical Products, LLC, Northglenn, CO, by letter on April 30, 2003.
Firm initiated recall is ongoing.
REASON
Finished products were not sterilized.
VOLUME OF PRODUCT IN COMMERCE
32,800 units.
DISTRIBUTION
Nationwide, Canada, and Saudia Arabia.
______________________________
PRODUCT
Cryo Valve Allograft, Pulmonary Heart valve & Conduit.
Recall # Z-0861-03.
CODE
Model #PVOO, Serial #7916346.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on May 5, 2003. FDA initiated recall
is ongoing.
REASON
Microorganisms were detected in associated allografts after initial release
of donor.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Multi-Link Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13.
Recall # Z-0862-03.
CODE
Lot 3021951.
RECALLING FIRM/MANUFACTURER
Guidant Corporation ACS, Temecula, CA, by letter dated May 6, 2003. Firm initiated
recall is ongoing.
REASON
Sterility compromised.
VOLUME OF PRODUCT IN COMMERCE
40.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Cryo Valve Allograft, Heart valve. Recall # Z-0866-03.
CODE
Donor #61838, Serial #7691913, Model #SGPVOO;
Donor #65235, Serial #7915089, Model #SGAVOO;
Donor #64922, Serial #7883079, Model #SGAVOO;
Donor #64779, Serial #7883080, Model #SGPVOO;
Donor #64779, Serial #7888910, Model #SGPVOO;
Donor #64779, Serial #7888909, Model #SGAVOO; and
Donor #63941, Serial #7894710, Model #SGPVOO.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on April 30, 3003. FDA initiated recall
is ongoing.
REASON
Microorganisms were detected in associated allografts.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
CA, and IL.
_____________________________
PRODUCT
Misys Laboratory System. Recall # Z-0867-03.
CODE
Versions 5.2, 5.23, 5.3, 5.3.1, and 5.3.2.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on April 14, 2003. Firm initiated
recall is ongoing.
REASON
Incorrect results could be filed.
VOLUME OF PRODUCT IN COMMERCE
193.
DISTRIBUTION
Nationwide, Ireland, Canada, Denmark, United Kingdom, Saudi Arabia, and United
Arab.
_____________________________
PRODUCT
Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option
with firmware version 2.45 or lower. Recall # Z-0869-03.
CODE
Genesis 100, 150 & 200, Tecan PosID2 units with firmware version 2.5 or lower.
RECALLING FIRM/MANUFACTURER
Tecan U.S. Inc., Durham, NC, by letter, and via e-mail on/about March 13, 2003.
Firm initiated recall is ongoing.
REASON
Firmware defect. Under certain conditions a strip rack is no longer in the initial
position after a motor overload of the barcode scanner PosID2.
VOLUME OF PRODUCT IN COMMERCE
327 instruments.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
a) Elecsys Troponin T; catalog number 2017644. Recall # Z-0870-03;
b) Elecsys Troponin T STAT; catalog number 2017423.
Recall # Z-0871-03.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, by letter on April 21, 2003. Firm
initiated recall is ongoing.
REASON
Hemoglobin interference limitation revised downward; hemolyzed samples may result
in false negative results.
VOLUME OF PRODUCT IN COMMERCE
26,961 kits.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The
product is shipped 4 cartridges per carton. Recall # Z-0873-03.
CODE
Product code number RF451. Lot number CD4085 Exp 3/25/04.
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE, by telephone on April 24, 2003, and by letter
dated April 25, 2003. Firm initiated recall is ongoing.
REASON
Test results may be inaccurate by 0.2 to 0.5 ng/mL.
VOLUME OF PRODUCT IN COMMERCE
662 cartons.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
Recall # Z-0835-03;
b) Philips MX8000 Dual v, Exp CT Scanner, utilizing V2.0 software.
Recall # Z-0836-03;
CODE
a) Serial Numbers: 3094 through 3196;
b) Serial Numbers: 3008 through 3169.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland), Inc., Highlands Heights, OH, by a "Product
Safety Notification", dated April 2, 2003. Firm initiated recall is ongoing.
REASON
Patient images may be incorrectly stored in the archive directory of a different
patient.
VOLUME OF PRODUCT IN COMMERCE
187 units.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
Protege Self-Expanding Nitinol Stent 6 mm x 40 mm, model number SER6-40-135.
Recall # Z-0863-03.
CODE
Lot Number 132612.
RECALLING FIRM/MANUFACTURER
Ev3, Inc., St. Paul, MN, by letter dated April 15, 2003. Firm initiated recall
is ongoing.
REASON
The label has an expiration date of August 2005, but the correct expiration
date is February 2005.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
Nationwide, and Internationally.
________________________________
PRODUCT
a) Acuson Diagnostic Ultrasound System Transducer; Model Number(s):
L582 Linear Array Transducer for use on the 128XP Ultrasound
System; Catalog Numbers: 23656 (New), 45441 (Refurb).
Recall # Z-0864-03;
b) Acuson Diagnostic Ultrasound System Transducer; Model Number(s):
L582 Linear Array Transducer for use on the 128XP Ultrasound
System; Catalog Numbers: 23656 (New), 45441 (Refurb).
Recall # Z-0865-03;
CODE
All Serial Numbers: XXXXXXXX (8-digit).
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letters on March 24, 2003. Firm initiated recall is ongoing.
REASON
The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.
VOLUME OF PRODUCT IN COMMERCE
220 units.
DISTRIBUTION
Nationwide, and Internationally.
________________________________
PRODUCT
ACCESS Estradiol Reagent Test System. Recall # Z-0872-03.
CODE
Lot number 215173.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter dated May 8, 2003. Firm initiated recall is ongoing.
REASON
Short volume, resulting possibility of falsely elevated results.
VOLUME OF PRODUCT IN COMMERCE
1,593 kits.
DISTRIBUTION
Nationwide and Canada.
END OF ENFORCEMENT REPORT FOR JUNE 4, 2003
###
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