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U.S. Department of Health and Human Services

Safety

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Enforcement Report for February 4, 2004

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.


February 4, 2004
04-05

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Oxycodone Hydrochloride Oral Concentrate Solution, 20
mg/mL, 30 mL bottle, Rx only. Recall # D-105-4.
CODE
8558E12384 Exp. 08/05; 8558E12385 Exp. 09/05; 8558E12386 Exp. 09/05; 8558E12387 Exp 09/05; 8558E12388 Exp. 09/05; and 8558E14997 Exp. 10/05.
RECALLING FIRM/MANUFACTURER
Mallinckrodt Inc., Hobart, NY, by letters dated January 15, 2004. Firm initiated recall is ongoing.
REASON
Defective Dropper: The ink graduated markings dissolve when stored in the product which may result an inaccurate administration of prescribed dose.
VOLUME OF PRODUCT IN COMMERCE
17,130 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
ACEON(r) (Perindopril erbumine) Tablets, 2 mg, 100 count
bottles, Rx only. Recall # D-106-4.
CODE
Lot Numbers/Expiration Dates: 3025305 (30 June 2004) and 3025306 (30 June 2004).
RECALLING FIRM/MANUFACTURER
Solvay Pharmaceuticals Inc., Marietta, GA, by letter on January 20, 2004
REASON
Degradation Products: Related compound specification failure (l8 month stability).
VOLUME OF PRODUCT IN COMMERCE
4,504 bottles.
DISTRIBUTION
Nationwide and Puerto Rico.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
Mammography X-Ray Systems. Recall # Z-0282/0287-04.
CODE
Model Number: Seneographe 2000D, DMR (all versions), 700T, 800T, 500 (all versions), and 600 (all versions).
RECALLING FIRM/MANUFACTURER
General Electric Medical System, Waukesha, WI, by letter beginning on January 14, 2004. Firm initiated recall is ongoing.
REASON
The Mammography System's user information was missing the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.
VOLUME OF PRODUCT IN COMMERCE
6,931 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Drager Sola 500 Surgical Lamp and Steris Harmony LL 500
Surgical Lamp. Recall # Z-0358-04;
b) Drager Sola 700 Surgical Lamp and Steris Harmony LL 700
Surgical Lamp. Recall # Z-0359-04.
CODE
Catalog numbers 4115571, YG18568, YG19051, and YG19262.
RECALLING FIRM/MANUFACTURER
Drager Medical, Inc., Telford, PA, by letter dated January 9, 2003. Firm initiated recall is ongoing.
REASON
The adjustment screw may break due to material fatigue.
VOLUME OF PRODUCT IN COMMERCE
51 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
ICON 25 h CG test kit. Recall # Z-0374-04
CODE
Lot HCG030732.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA, by letter on December 22, 2003. Firm initiated recall is ongoing.
REASON
Test can exhibit false negative results.
VOLUME OF PRODUCT IN COMMERCE
7,668.
DISTRIBUTION
Nationwide.

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PRODUCT
Cidex Plus Test Strips. Recall # Z-0375-04.
CODE
Product code 2924 - Lot 010185; Product code 2926 - Lot 010252.
RECALLING FIRM/MANUFACTURER
Advanced Sterilization Products, Irvine, CA, by emails sent December 12, 2003 to December 19, 2003. Firm initiated recall is ongoing.
REASON
Product may not accurately detect minimum effective concentration (MEC).
VOLUME OF PRODUCT IN COMMERCE
710 cases, 2 bottles per case.
DISTRIBUTION
Nationwide, Japan, Puerto Rico, Latin America, and the Caribbean.

_______________________________
PRODUCT
Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832. Recall # Z-0376-04.
CODE
Serial numbers 108050HR, 108183HR, 108298HR, 109036HR, 109216HR, 109622HR, 110004HR, 110700HR, 111126HR, 111270HR, 111540HR, 112441HR, 201178HR, 308361HR/308440HR, 309001HJ/309030HJ, 309001HR/309345HR 309001HW/309015HW, 310001HG/310010HG , 310001HW/310010HW , 310007HR/310088HR, and HR1976/HR27480. Only those pumps within these serial numbers with installed motor assemblies from date codes 33/03, 34/03 and 35/03 are affected.
FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL, by letters dated December 17, 2003. Firm initiated recall is ongoing.
REASON
Premature motor failure.
VOLUME OF PRODUCT IN COMMERCE
188 units.
DISTRIBUTION
Nationwide and Internationally.

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PRODUCT
Micromix BCR Compounder, product code 2M8297; a pharmacy automation device with a barcode reader used in preparation of parenteral solutions. Recall # Z-0377-04.
CODE
Serial numbers T2001/T20014, T20016/T20018, T20021, T20023/T20028.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL, by telephone December 16, 2003. Firm initiated recall is complete.
REASON
The compounder may omit an ingredient during the compounding process.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
WI and UT.

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PRODUCT
MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens). Recall # Z-0378-04.
CODE
SFC-25 (8 lots) 1180608, 1181078, 1181170,1181171, 1181396, 1181397, 1182237, 1184864 MTC-60 (25 lots) 1177222, 1177950, 1178121, 1178212, 1176868, 1177421, 1178738, 1178883, 1178885, 1179023, 1181789, 1181790, 1181797, 1181798, 1181980, 1182245, 1182342, 1182343, 1182344, 1182345, 1182675, 1182676, 1182677, 1182761.
RECALLING FIRM/MANUFACTURER
Staar Surgical Co, Inc., Monrovia, CA, by recall notice on January 6, 2004. FDA initiated recall is ongoing.
REASON
Increased numbers of lens tears during placement of lens into eye.
VOLUME OF PRODUCT IN COMMERCE
29,021.
DISTRIBUTION
Nationwide, Canada and Australia.

_______________________________
PRODUCT
CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hydrophilic) replaced in 30 days or less. Contains hydrogen peroxide as the disinfecting agent. 12 Fl. Oz (355 ML). (OTC) Item Number: 191648. Recall # Z-0379-04.
CODE
All lot codes.
RECALLING FIRM/MANUFACTURER
CVS, Woonsocket, RI, by letter and e-mail on November 19, 2003. Firm initiated recall is ongoing.
REASON
Product label fails to provide adequate warning for use.
VOLUME OF PRODUCT IN COMMERCE
19,261 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile
6 ply-4.5 in x 4.1 yd Product Number: 3331.
Recall # Z-0380-04;
b) Kendall Kerlix Large Roll, 4.5 in X 4.1 yd, Sterile
Product Number: 6730. Recall # Z-0381-04;
c) Kendall Curity Disposable Laparotomy Sponges, 12 in x 12
in, Sterile Product Number: 6034. Recall # Z-0382-04.
CODE
a) Lot Number: 33492700;
b) Lot Numbers: 33462700 33462701 33462702 33462703
33472700 33472701;
c) Lot Number: 33452700.
RECALLING FIRM/MANUFACTURER
Kendall Healthcare Products Co., Mansfield, MA, by letters on January 8, 2004. Firm initiated recall is ongoing.
REASON
Sterility compromised due to lack of package seal integrity.
VOLUME OF PRODUCT IN COMMERCE
193 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Products are various dental surgical drills packed in a
sealed tray and labeled as sterile. The tray is labeled
as follows: 3i Implant DC500 LOT 5.0mm Implant
Disposable Countersink Pilot Drill STERILE.
Recall # Z-0383-04;
b) Products are various dental surgical drills packed in a
sealed tray and labeled as sterile. The tray is labeled
as follows: DDK315 LOT Disposable Drill Kit with DT315
STERILE. Recall # Z-0384-04;
c) Products are various dental surgical drills packed in a
sealed tray and labeled as sterile. The tray is labeled
as follows: DT220 2.3mm (D)x 20.0 mm (L) STERILE.
Recall # Z-0385-04;
d) Products are various dental surgical drills packed in a
sealed tray and labeled as sterile. The tray is labeled
as follows: DT 310 LOT 3.0 mm (D) X 10.0 mm (L) STERILE.
Recall # Z-0386-04;
Products are various dental surgical drills packed in a
sealed tray and labeled as sterile. The tray is labeled
as follows: DT423 LOT 4.25 mm (D) X 13.0 mm (L)
Disposable Twist Drill STERILE. Recall # Z-0387-07.
CODE
a) Lot # 219630;
b) Lot # 220995 and 221052;
c) Lot # 219636;
d) Lot # 221285;
e) Lot # 221393.
RECALLING FIRM/MANUFACTURER
Implant Innovations, Inc., by e-mail and fax on December 2, 2003. Firm initiated recall is ongoing.
REASON
The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots.
VOLUME OF PRODUCT IN COMMERCE
565.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Holdex(r) + Butterfly, Blood Collection Set, Single use only. Sterile. Recall # Z-0388-04.
CODE
Item # 450271, Lot # 12-8461.
FIRM/MANUFACTURER
Greiner VACUETTE North America, Monroe, NC, by letter or fax on December 16, 2003. Firm initiated recall is ongoing.
REASON
Product may have a defective connection.
VOLUME OF PRODUCT IN COMMERCE
5 cases (5000 pieces).
DISTRIBUTION
IN, NY, and TX.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
a) ARCHITECT(r) Folate Low and Medium Controls, List 6C12-10;
the kit contains 2 - 8 mL vials, Low Control L 2.5 ng/mL
and Medium Control M 7.0 ng/mL; Recall # 0361-04;
b) ARCHITECT Folate High Controls, List 6C12-11; the kit
contains 8 - 1 mL vials of High Control H 15.0 ng/mL.
Recall # 0362-04;
c) ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL
bottle of ARCHITECT Folate Manual Diluent containing
TRIS buffer with protein stabilizer. Recall # 0363-04;
d) ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL
(100 tests) and 25.9 mL (500 tests) bottles containing
TRIS buffer with protein stabilizer, contained in
ARCHITECT Folate Reagent Kit (Lists 6C12-20, 6C12-25,
6C12-30). Recall # 0364-04;
e) AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL
bottles containing TRIS buffer with protein
stabilizer. Recall # 0365-04;
f) AxSYM Folate RBC Protein Diluent Pack, list 3C81-65; one
13 mL bottle contains human albumin. Recall # 0366-04;
g) AxSYM Folate Medium Control Pack, list 3C81-11, the pack
contains 8 - 1 mL vials of Medium Control M 7.0 ng/mL.
Recall # 0367-04;
h) Folate Low and High Controls, list 9C13-10; the pack
contains 8 - 2 mL bottles( 4 for each level), Low
Control L 2.5 ng/mL and High Control H 15.0 ng/mL.
Recall # 0368-04;
i) IMx Folate Medium Control, list 2220-11; the pack
contains 8 - 1 mL bottles of IMx Folate Medium Control M
7.0 ng/mL. Recall # 0369-04;
j) IMx Folate Mode 1 Calibrator Pack, list 2220-40, the
pack contains 3 - 2 mL bottles of IMx Folate Mode 1
Calibrator 3.0 ng/mL. Recall # 0370-04;
k) IMx Specimen Diluent Pack, list 2220-50; 1 - 10 mL
bottle containing TRIS buffer with human albumin.
Recall # 0371-04;
l) IMx Folate Ion Capture Component Set, list 2220-88; the
set consists of 1 IMx Folate Reagent Pack, 100 tests,
list 2220-20, and 100 Ion Capture reaction cells.
Recall # 0372-04.
CODE
a) List 6C12-10, Lots 94718M200 and 04619M100;
b) List 6C12-11, Lot 06867M200;
c) List 6C12-50, Lots 07460M300, 11435M100;
d) List 6C12Y: lots 06537M100Y, 09888M100Y, 06537M101Y,
05081M100Y, 07465M300Y and 10587M200Y. These diluent
lots were packaged in the following reagent kit lots:
List 6C12-20 (4 x 100 tests), lots06537M100 and
09888M100; List 6C12-25 (100 tests), lots 06537M101and
05081M100; List 6C12-30 (4 x 500 tests), lots 07465M300
and 10587M200.
e) List 3C81-50, lots 91555M100, 05920M200;
f) List 3C81-65, lot 06783M100;
g) List 3C81-11, lot 01552M100;
h) List 9C13-10, lots 95523M200, 08899M100;
i) List 2220-11, lots 06320M200, 09655M100;
j) List 2220-40, lots 02181M200, 04441M300, 06371M200;
k) List 2220-50, lots 03234M300, 04030M300;
l) List 2220-88, lots 90376M300 and 90376M301.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, via e-mail on December 16, 2003 and January 5, 2004 and by letters dated December 16, 2003 and December 31, 2003. Firm initiated recall is ongoing.
REASON
There is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
VOLUME OF PRODUCT IN COMMERCE
12,388 packs.
DISTRIBUTION
Internationally.

_______________________________
PRODUCT
Directigen (tm) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog # 256030. Recall # Z-0373-04.
CODE
Lots 3253709, exp 12/18/03 and 3289760, exp 2/20/04.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Sparks, MD, by fax, e-mail, and letters on December 15, 2003. Firm initiated recall is ongoing.
REASON
Diagnostic test kit may exhibit false positive results.
VOLUME OF PRODUCT IN COMMERCE
600 kits.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS I

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PRODUCT
3-Nitro 20, Roxarsone Type-A Medicated Article, packaged in 50-lb bags. Active ingredient is 3-Nitro-4-hydroxyphenylarsonic acid (roxarsone) 20%. Recall # V-002-4.
CODE
Lot Number: AB 720575, EXP 08-05.
RECALLING FIRM/MANUFACTURER
Land O Lakes Inc., Washington Courthouse, OH, by telephone on January 22, 2003. Firm initiated recall is complete.
REASON
Type-A Medicated Feed Article was shipped illegally to an unlicensed Feed Mill.
VOLUME OF PRODUCT IN COMMERCE
20-50 Lb. bags.
DISTRIBUTION
OH.

END OF ENFORCEMENT REPORT FOR February 4, 2004

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