DECEMBER 2002

 

WEEK ENDING DECEMBER 7

 

PRODUCT MYO/WIRE™ Temporary Cardiac Pacing Wire. The wire has a piece for connecting to a generator on one end and the opposite end has a hook shaped needle designed for contact with the heart. Outer carton labeled in part, ”MYO/WIRE***Temporary Cardiac Pacing Wire***Soft multi-stranded surgical steel wire***Extruded PTFE insulation*** ***Contents: 24 individual sterile wires***Instructions for use and warnings inside box.***Single use. Do not resterilize.” The INCORRECT Insert is labeled in part:  "MYO/WIRE II Sternotomy Sutures.

The CORRECT insert is labeled in part: “MYO/WIRE Temporary Cardiac Pacing Wires.

CODE Catalogue No. 021-001 Lot #0378A.

RECALLING FIRM/MANUFACTURER Alto Development Corp., Farmingdale, NJ

REASON Insert mixup.

VOLUME OF PRODUCT IN COMMERCE 120 boxes of 24 devices.

DISTRIBUTION Nationwide and in Europe.

 

PRODUCT AC/DC portable aspirators manufactured under the following brand names: Gomco OptiVac Aspirator, Model G178; w/carrying case, Model GC178 Life Support Products OptiVac Aspirator, Model L178; w/carrying case, Model LC178 Schuco OptiVac Aspirator, Model S178; w/carrying case Model SC178 RX device.

CODE Units with a serial number beginning with the letter T, U, or V or any units with a serial number that starts with the year 1999, 2000, or 2001 (for example T9274 or 20010426002).

RECALLING FIRM/MANUFACTURER Allied Healthcare Products, Inc., St. Louis, MO

REASON Power supply could overheat.

VOLUME OF PRODUCT IN COMMERCE 5,780 units.

DISTRIBUTION Nationwide.

 

PRODUCT Boehringer Suction Regulator, Suction Regulator.

CODE Model number 3710 Lot numbers 01I, 01J, and 01K.

RECALLING FIRM/MANUFACTURER Boehringer Laboratories, Norristown, PA

REASON Units provided three positions instead of the described two.

VOLUME OF PRODUCT IN COMMERCE 34 units.

DISTRIBUTION VA and CA.

 

PRODUCT Spacelabs Burdick Cassette Holter Recorders, Models 90205 (2 channel) and 90208 (3 channel).

CODE Model 90205 (2 Channel) Holter Recorders with the following serial numbers are subject to the recall: 10730001128, 10730001129, 10730001130, 10730001131, 10730001132, 10730001133, 10730001134, 10730001135,10730001136, 10730001137, 10730001139, 10730001140, 10730001142, 10730001145, 10730001146, 10730001148, 10730001151, and 10730001152.

Model 90208 (3 Channel) Holter Recorders with the following serial numbers are subject to the recall:  10740000903, 10740000905, 10740000906, 10740000907, 10740000908, 10740000909, 10740000910, 10740000911, 10740000912, 10740000913, 10740000914, 10740000919, 10740000920,

10740000923, 10740000925, 10740000927, 10740000928, and 0740000929.

RECALLING FIRM/MANUFACTURER Spacelabs Burdick, Inc., Deerfield, WI

REASON The tape head slide spring may cause the tape speed to change.

VOLUME OF PRODUCT IN COMMERCE 36 units.

DISTRIBUTION CA, NM, TN, VA and Germany and Portugal.

 

PRODUCT a) Micro-Lite Phototherapy System, Model PTS68-1; b) Infant Intensive Care System 7850 Phtotherapy, Model PTM78-3.

CODE Model PTS68-1 all serial numbers since original release in February 1999.

RECALLING FIRM/MANUFACTURER Hill-Rom Air-Shields, Hatboro, PA

REASON The power supply malfunctions, causing the unit to become inoperable.

VOLUME OF PRODUCT IN COMMERCE 825 units (MicroLite) and 1619 units (PTM78-3).

DISTRIBUTION Nationwide and Internationally.

 

WEEK ENDING DECEMBER 14

 

PRODUCT Medtronic RF Enhancr SC Single-Curve Steerable Ablation Catheters,Model numbers 11744523, 11745523, 11745533, 19745533, 19746534; Medtronic RF Enhancr NTC (Non-Thermocouple) Steerable Mapping/Ablation Catheters, Model numbers 21744523, 21745523, 29745533, 29746534.
CODE Model 11744523, lot numbers FA11245, FA11256, FA11256A, FA11257, FA11370, FA11606, FA11777, FA11831, FA11895, FA11895A, FA11990, FA12056, FA12104, FA12186, FA12299, FA12378, FA12477, FA12540, FA12726, and FA12908

Model 11745523, lot numbers FA11359, FA11369, FA11660, FA11660B, FA11778, FA11778B, FA11832, FA11832B, FA11991, FA12105, FA12300, FA12423, FA12478, FA12478A, FA12645, and FA12909

Model 11745533, lot numbers FA11243, FA11360, FA11368, FA11609, FA11658, FA11658A, FA11779, FA11833, FA11833C, FA11896, FA11992, FA12057, FA12106, FA12216, FA12256, FA12256A, FA12301, FA12302, FA12302B, FA12379, FA12479, FA12646, FA12727, and FA12910

Model 19745533, lot numbers FA11244, FA11255, FA11255A, FA11367, FA11615, FA11659, FA12058, FA12107, FA12107A, FA12303, FA12303A, FA12480, and FA12728

Model 19746534, lot numbers FA11242, FA11254, FA11364, FA11616; FA11661, FA12059, FA12108, FA12108A, FA12217, FA12257, FA12304, FA12380, FA12541, FA12541A, FA12729, FA12730, and FA12911

Model 21744523, lot numbers FA11361, FA11608, FA12258, FA12258A, FA12424, and FA12731

Model 21745523, lot numbers FA11607, FA11834, FA12055, FA12305, and FA12381

Model 29745533, lot numbers FA11362, FA11617, and FA12306

Model 29746534, lot numbers FA11253, FA11363, FA11897, FA12307, and FA12846.
RECALLING FIRM/MANUFACTURER Recalling Firm: Medtronic, Inc., Minneapolis, MN.
Manufacturer: Medtronic Puerto Rico, Inc., Villalba, RQ.
REASON In some of the catheters, the catheter manipulator wire detached from the catheter insulating tip anchor during operation of the catheter deflection mechanism and after detachment penetrated the catheter wall and protruded from the shaft.
VOLUME OF PRODUCT IN COMMERCE 500 catheters.
DISTRIBUTION Nationwide.

 

WEEK ENDING DECEMBER 21

 

PRODUCT Alumina V40 Head, Femoral Bearing Head, Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained Cemented or Nonporous Uncemented prosthesis.
CODE Product number: 6260-7-036 Lot Numbers: 3269301, 3515401, 3515402, 3516201
Product number: 6260-7-032 Lot Numbers: 2743801, 2743802, 2802001, 2963601, 2963602, 2967901, 2967902, 3487001, 3487101, 3547901, 3547902

***NEW*** Product Number: 6260-7-028 Lot Numbers: 2729301, 2729302, 2729303, 2729304, 2729305, 2735901, 2735902, 2735903, 3015901, 3015902, 3015903, 3015904, 3015905, 3050901, 3052401, 3052402, 3052403, 3052404, 3225601, 3225603, 3225604, 3225605, 3323801, 3323802, 3486701, 3577001, 3577002, 3631501.
RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ.
Manufacturer: Stryker Howmedica Osteonics Corp. Co., Cork, Ireland.
REASON V40 Alumina Heads may not assemble properly onto V40 hip stems.
VOLUME OF PRODUCT IN COMMERCE 190 (+676 28mm heads).
DISTRIBUTION Nationwide and United Kingdom, Australia, France, and Italy.

 

PRODUCT Epidural Catheterization Kit, model number AK-05503L. The kit is labeled as containing a 19 gauge catheter. The catheter permits access to the epidural space.
CODE Lot number RF2088943.
RECALLING FIRM/MANUFACTURER Arrow Intl., Inc., Reading, PA.
REASON Mislabeled - package may contain incorrect gauge catheter.
VOLUME OF PRODUCT IN COMMERCE 720 kits.
DISTRIBUTION IL, CA, IN, KY, and OH.

 

PRODUCT Qwikwash Tubing (Air, Waste, Water), list 6208-23; an accessory for use with the Abbott Commander Parallel Processing Center (PPC) and Qwikwash Instruments; each package contains 3 pieces of tubing.
CODE All lots shipped between 4/26/2002 and 6/28/2002. There are no lot numbers on the tubing packages. The affected tubing sets can be identifed by the lack of the TYGON logo imprinted on both the Water Tubing (tubing with black connectors) and the Air Tubing (tubing with white connectors).
RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Inc., Abbott Park, IL.
Manufacturer: Abbott Laboratories, Inc., Irving, TX.
REASON Visual discoloration of water tubing assembly.
VOLUME OF PRODUCT IN COMMERCE 1343.
DISTRIBUTION Nationwide, Canada, Germany and Singapore.

 

PRODUCT
Trade Name: ABC Fixation Pin.
System Name: ABC Cervical Plating System.
Common Name: Plate Fixation Pin. The device product number is FJ833R and sold 2 per box.
CODE Lot number 51133750.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aesculap, Inc., Center Valley, PA.
Manufacturer: Aesculap Ag & Co., Kg. Tuttlingen, Donau.
REASON Pin manufactured with sharp tip and not hardened, pin may be susceptible to bending.
VOLUME OF PRODUCT IN COMMERCE 216 kits.
DISTRIBUTION Nationwide.

 

WEEK ENDING DECEMBER 28

 

PRODUCT Detection Reagent 1 of Digene's Hybrid Capture(TM) System Human Papilloma Virus DNA Assay test kit, catalog #4401-1030.
CODE Lot 1601, EXP 2003-05-20 Lot 1733, EXP 2003-05-31.
RECALLING FIRM/MANUFACTURER Digene Corp., Gaithersburg, MD.
REASON IVD test kit reagent may give false negative results.
VOLUME OF PRODUCT IN COMMERCE 217 kits.
DISTRIBUTION Internationally.


PRODUCT Stryker Wedge turning frame stretcher, model 965.
CODE All units manufactured from 11/01/01 through 10/15/02. Serial numbers: 0205044264, 0207045797, 0111036590, 0202043279, 0202043280, 0208043250, 0206045817, 0206045818, 0206045819, 0204045104, 0204045393, 0204045394, 0111036727, 0111036728, 0204045278, 0204045276, 0204045277, 0204045315, 0204045177, 0207045798, 01110036522, 0111036523, 011203618, 020142290, 0205044263, 0203043636, 0111036534, 0111036535 and 0208043371.
RECALLING FIRM/MANUFACTURER Stryker Corp., Kalamazoo, MI.
REASON Weld failure-anterior and posterior frame may dislodge from stretcher litter.
VOLUME OF PRODUCT IN COMMERCE 29.
DISTRIBUTION Nationwide and Internationally.


PRODUCT Little Soothers Cold pack. Each boxed set (unit) contains 3 patches. The Little Soother is a 3-inch by 2-inch sealed plastic liquid-filled patch. It was manufactured in three shapes: a yellow fish, a pink butterfly, and a blue penguin.
CODE The product is uncoded and is featured in campaigns 16-18 Wellness Magalog. Day lot codes: July 8, 9 and 10, 2002 (dates of manufacture)
RECALLING FIRM/MANUFACTURER Recalling Firm: Avon Products, Inc., New York, NY.
Manufacturer: Joy House, China. 
REASON Microbial contamination.
VOLUME OF PRODUCT IN COMMERCE 1609 units, each containing three Little Soothers.
DISTRIBUTION Nationwide.


PRODUCT Cryolife Valve Allograft.
CODE Model Number: PV00, Device Serial Number: 6570135.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON Donor tissue had possible sepsis secondary to pyogenic brain abscess.
VOLUME OF PRODUCT IN COMMERCE One individual heart valve allograft.
DISTRIBUTION IN.


PRODUCT HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Made in U.S.A.; The following models are affected:
a) Baxter HomeChoice Automated PD System, catalog 5C4471, 115 volt;
b) Baxter HomeChoice Automated PD System, catalog 5C4474, 220 volt;
c) Yume Automated PD System, catalog T5C4441, 100 volt;
d) Baxter HomeChoice PRO Automated PD System, catalog 5C8310, 115 volt;
e) Baxter HomeChoice PRO Automated PD System, catalog 5C8320, 220 volt;
f) Yume Plus Automated PD System, catalog T5C8300, 100 volt.
CODE All HomeChoice and HomeChoice PRO Systems with software versions 8.51 and 8.52.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL.
Manufacturer: Baxter Healthcare Corporation, Largo, FL.
REASON Possible overfill.
VOLUME OF PRODUCT IN COMMERCE 12,667 units.
DISTRIBUTION Nationwide and Internationally.