JANUARY 2003

 

WEEK ENDING JANUARY 10

 

 PRODUCT

AXIS/IRIX Gamma Camera System, controlled with Odyssey computers, operating with version 8.5 software. Recall # Z-0353-3/Z-0364-3.

The systems are controlled with Odyssey computers that are connected to a Prism gantry.  Some Odyssey computers operate as stand

alone workstations.A Prism XPVT System, Tomography, Computed, Emission, 90KPS System.

CODE

Serial Numbers:  101 to 763.

RECALLING FIRM/MANUFACTURER

Philips Medical Systems, Highland Heights, OH, by letter dated October 8, 2001. Firm initiated recall is ongoing.

REASON

A broken gantry wire may prevent the contact sensors from stopping motion of the unit.

VOLUME OF PRODUCT IN COMMERCE

653 devices installed.

DISTRIBUTION

Nationwide and Internationally.

 

 PRODUCT

LC+, LCV+, and LCA Angiographic X-ray Systems.  Recall # Z-0365-3/Z-0381-3.

CODE

All serial numbers of models 2168678, 2168678-2, 2219151, 2124824, 2168678-3, 2219150, 2107015, 2115906, 2168677, 2219152, 2219152-2. 

For model 2219151-2 serial numbers up to 349479BU6; for model 2219151-3 serial numbers up to 349678BU3;

for model 2219150-2 serial numbers up to 349089BU3; for model 2219150-3 serial numbers up to 350083BU2;

for model 2219152-3 serial numbers up to 348497BU9; and for model 2219152-4 serial numbers up to 347199BU2.

RECALLING FIRM/MANUFACTURER

Recalling Firm:  General Electric Medical Systems, Waukesha, WI, by letter on October 28, 2002.

Manufacturer:  GE Medical Systems Europe, 78533 Buc Cedex, France. Firm initiated recall is ongoing.

REASON

The motor gearshaft for the image intensifier may break allowing the image intensifier to slide down to its end stop.

VOLUME OF PRODUCT IN COMMERCE

1361 systems.

DISTRIBUTION

Nationwide and Internationally.

 

PRODUCT

BD DTX Plus Pressure Monitoring Kits and Extension Sets. Packaged as a single unit or assembled in pressure monitoring kits prior to

sterilization.  Recall # Z-0383-3/Z-0393-3.

CODE

Pressure Monitoring Kits

Ref. No.    Lot Number

682000      109178, 111271

682117      112035

682133      111025

686014      109020, 110026, 111030, 112028

686016      108029, 109022, 110028, 111032, 112030

686017      108030, 109023

687100      109026, 108086

687102      108087, 109027

697202      112169

687341      110517

Extension Kit

682100      112021.

RECALLING FIRM/MANUFACTURER

Recalling Firm: Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT, by telephone on July 8, 2002.

Becton Dickinson Critical Care Systems Pte Ltd., Singapore. Firm initiated recall is complete.

REASON

Bond between the tubing and female or male luer fitting may fail.

VOLUME OF PRODUCT IN COMMERCE

7122 pressure monitoring kits; 1450 extension sets.

DISTRIBUTION

Nationwide.

 

 PRODUCT

9 Fr. Percutaneous Sheath Introducer KitZs, catheter introducer.  Recall # Z-0394-3.

CODE

Product Number AK-09903-S, Lot numbers: RF2088607, RF2088664, RF2088828, RF2089239, RF2089338, and RF2100307.

Product Number CA-09903-LF, Lot numbers: RF2088835 and RF2089087.

Product Number NL-09903-S, Lot numbers: RF2089254 and RF2099563.

Product Number NM-07903, Lot numbers: RF2089116 and RF2089117.

Product Number NR-09903-S, Lot numbers: RF2088648, RF2088668, RF2089256, RF2099535, and RF2099786.

Product Number SM-01410, Lot number: RF2099718.

Product Number SM-09813-T, Lot numbers: RF2088795, RF2089001, and RF2089206.

Product Number SU-09903-S, Lot number: RF2088750.

RECALLING FIRM/MANUFACTURER

Arrow International, Reading, PA, by letters dated November 11, 2002. Firm initiated recall is ongoing.

REASON

Possibilty of leakage.

VOLUME OF PRODUCT IN COMMERCE

25130 kits.

DISTRIBUTION

Nationwide and Internationally.

 

 PRODUCT

Digene's Rapid Capture System (RCS) robotic microplate processor, Catalog #6000-3111. Recall # Z-0395-3.

CODE

S/Ns 1922, 2491, 2707, 2721, and 2730.

RECALLING FIRM/MANUFACTURER

Digene Corp., Gaithersburg, MD, by letters dated November 11, 2002. Firm initiated recall is ongoing.

REASON

IVD instrument may measure incorrect sample volume for clinical testing.

VOLUME OF PRODUCT IN COMMERCE

5 units.

DISTRIBUTION

MD, IN and OR and Japan.

 

 PRODUCT

Holdex tube holder. Recall # Z-0396-3.

CODE

Item# 450261,Lot# A020208 and A050113

RECALLING FIRM/MANUFACTURER

Recalling Firm: Greiner Vacuette North America, Inc., Monroe, NC, by letter dated September 11, 2002. Firm initiated recall is ongoing.

REASON

Holdex tube holder malfunction: the inner metal tube of device dislodged.

VOLUME OF PRODUCT IN COMMERCE

Lot# A020208-9800 pieces; Lot#A050113-23800 pieces.

DISTRIBUTION

Nationwide.

 

 PRODUCT

Medex Vented Flow Clip Nitroglycerin Set, Pv22ml, sterile, packaged 20 units per case. Recall Z-0397-3.

CODE

Lot Numbers: 29A140110, 29B080171, 29B230184, 29F040045, 29G260064, 29K290194, 31K290061, and 32C260065.

Catalog Number: FC7A01

RECALLING FIRM/MANUFACTURER

Recalling Firm:  Medex, Inc., Dublin, OH, by telephone and fax beginning October 17, 2002.

Manufacturer:  Medex, Inc., Hilliard, OH. Firm initiated recall is ongoing.

REASON

Product contains latex, however the label incorrectly states 'Latex  Free'.

VOLUME OF PRODUCT IN COMMERCE

304 cases (6,080 units).

DISTRIBUTION

IL, AL, FL, UT, NY, and CA.

 

 PRODUCT

Myocardial Temperature Probe, YSI 400 Series, 15mm, packaged in sterile and non-sterile pouches, 20 or 40 pouches per carton.

Catalog #81-030415 and #81-031415. Recall # Z-0406-3.

CODE

Lots 209250, 216868, 219928, 223738, 224871, 229899, 241142, 243500, 248570, 249581, 255258, 256627, 260922, 261583, 265552, 268217, 203166, and 228438.

RECALLING FIRM/MANUFACTURER

Deroyal Surgical, Rose Hill, VA, by letter on September 17, 2002. Firm initiated recall is ongoing.

REASON

Surgical device is mislabeled with incorrect size.

VOLUME OF PRODUCT IN COMMERCE

3000 units.

DISTRIBUTION

Nationwide.

 

WEEK ENDING JANUARY 17


PRODUCT
Blue-Vis, CIBASOFT VISITINT, daily wear contact lens. Recall # Z-0342-3;
CODE
Lot number: 1170119, Expiration: 2007/10, Prescription: base curve 8.9, diameter 13.8, power -1.50.
RECALLING FIRM/MANUFACTURER
Ciba Vision Corporation, Duluth, GA, by letter on November 12, 2002 with attached Business Reply Card form. Firm initiated recall is ongoing.
REASON
Lenses were labeled with the wrong prescription.
VOLUME OF PRODUCT IN COMMERCE
559 vials.
DISTRIBUTION
CA, GA, IL, MN, NJ, TX, VA and Internationally.


PRODUCT
Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastomer, Sterile/R, REGENT, One Pair sterile gloves packaged 50 pair per box/ 4 boxes per case/ total 200 pair per case. Recall # Z-0346-3.
CODE
Lot numbers 01H0161 through 01H2668.
RECALLING FIRM/MANUFACTURER
SSL Americas Inc., Norcross, GA, by telephone and letter November 25, 2002. Firm initiated recall is ongoing.
REASON
Sulfur particles on the surface of gloves.
VOLUME OF PRODUCT IN COMMERCE
173,310 pairs
DISTRIBUTION
Nationwide and Canada, Venezuela and British Colombia.


PRODUCT
a) SureStep 50 Test Strips, For the measurement of glucose in whole blood, Two bottles of 25 Test Srips, LIFESCAN.
Recall # Z-0398-3;
b) Genuine One Touch Glucose 50 Test Strips, For the quantitative measure of glucose in whole blood, For Sale
Outside of the USA and Canada. Product is packed two vials of 25 strips per vial. Recall # Z-0399-3;
CODE
a) Lot: E-169380A, Exp: 2003-01;
b) Lot# 1666680A Exp. 2003-11.
RECALLING FIRM/MANUFACTURER
River City Drug, Marietta, GA by letters on/about October 8, 2002. Firm initiated recall is ongoing.
REASON
Products labeled 'For Sale Outside The USA and Canada,' were being offered for sale in the U.S.
VOLUME OF PRODUCT IN COMMERCE
a) 576 units (Sure Step);
b) 2790 units (Genuine One Touch).
DISTRIBUTION
Nationwide.


PRODUCT
Ohmeda Medical Giraffe(tm) Omnibeds; and Ohmeda Medical Giraffe(tm) Incubators. Recall # Z-409-3.
CODE
For corrections due to unintended movement of the Elevating Base the Giraffe OmniBeds and Giraffe Incubators are each identified with a unique S/N beginning with HDGD*****, HDGE*****, HDGF*****, HDHF**** and HDHE*****, where "*****" refers to 5 digit numbers less than 54000.

For corrections of the leakage current defect in the devices, the Giraffe OmniBeds and Giraffe Incubators are each identified with a unique S/N beginning with HDGD*****, HDGE*****, HDGF*****, HDHF***** and HDHE*****, where "*****" refers to 5 digit numbers less than 53000.

For corrections of the battery defect in the devices, the Giraffe OmniBeds and Giraffe Incubators are each identified with a unique S/N beginning with HDGD*****, HDGE*****, HDGF*****, HDHF***** and HDHE*****, where "*****" refers to 5 digit numbers less than 52000.
RECALLING FIRM/MANUFACTURER
Ohmeda Medical, Laurel, MD, by letter on October 21, 2002. Firm initiated recall is ongoing.
REASON
Electrical defects in neonatal incubators may lead to unintended movement.
VOLUME OF PRODUCT IN COMMERCE
1364 units.
DISTRIBUTION
Nationwide and Internationally.


PRODUCT
Side Fire Laser Fibers, Models;
a) DBLF-60SF;
b) HBLF-60SF.
Recall # Z-0411-3.
CODE
a) lot numbers LP-260, LP-262, LP-266, and LP-267;
b) lot numbers LP-258, LP-260, LP-263, LP-265 and LP-271.
RECALLING FIRM/MANUFACTURER
Laser Peripherals, LLC., Golden Valley, MN, by telephone on October 15, 2002. Firm initiated recall is ongoing.
REASON
The laser fibers were manufactured with an expired epoxy sealant which could result in degradation and misdirection of the laser beam.
VOLUME OF PRODUCT IN COMMERCE
159 laser fibers.
DISTRIBUTION
Nationwide, Canada and Japan.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III


PRODUCT
Contigen Bard Collagen Implant. The product is one syringe filled with Contigen. Description: Contigen Bard collagen implant is a sterile, nonpyrogenic device composed of highly purified bovine dermal collagen. Recall # Z-0344-3.
CODE
Product Code 651005, Lot No.: 03GM2009, Exp.: 04/12.
RECALLING FIRM/MANUFACTURER
C.R. Bard, Inc., Urological Division, Covington, GA, by letters on November 4, 2002. Firm initiated recall is ongoing.
REASON
Contigen Bard Collagen Syringe cartons have incorrect expiration dates.
VOLUME OF PRODUCT IN COMMERCE
306 units.
DISTRIBUTION
Nationwide.


PRODUCT
EXPO 32 Software. Recall # Z-0407-3.
CODE
Versions 1.0, 1.1B, and 1.2.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on May 20, 2002. Firm initiated recall is ongoing.
REASON
Software contains errors that might affect Cytometry instruments.
VOLUME OF PRODUCT IN COMMERCE
33.
DISTRIBUTION
Nationwide.


PRODUCT
Cryo-Tip T-1910 Exo-Endocervical, Part Number 90501 (as labeled) for use with the Circon Cryomedics MT-700 Cryosurgical System. Recall # Z-412-3.
CODE
Lot TMDFC.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ACMI Corporation, Racine, WI, by telephone on June 19, 2002. Manufacturer: Circon Acmi, Norwalk, OH. Firm initiated recall is ongoing.
REASON
Derm Bevel Cryo-Tips, Part Number 90512, were mislabeled as Exo-Endocervical Cryo-Tips, Part Number 90501.
VOLUME OF PRODUCT IN COMMERCE
7 Cryo-tips.
DISTRIBUTION
CA and TX.
 

 

WEEK ENDING JANUARY 24


PRODUCT
Drop Hooks for Xact (tm) Lo-Pro with Removeable Drop Seat, Xact Integrated, and Xact Individual with Integrated Drop Seat wheelchairs, model/item numbers 05D, 1D, and 15D. Packaged as set of four in a poly bag. Recall # Z-316/318-3.
CODE
Drop Hooks are components of the wheelchair seat cushions coded as XLPD1516 XLPD1616 XLPD1618 XLPD1816 XLPD1717 XLPD1818 XLPI1516 XLPI1616 XLPI1816 XLPI1717 XLPI1818 XD... followed by one or more of the following, listed in product number: IDS, 05D, 1D, and 15D
RECALLING FIRM/MANUFACTURER
Action Products Incorporated, Hagerstown, MD, by letter on May 14, 2002. Firm initiated recall is complete.
REASON
Wheelchair seat component is defective.
VOLUME OF PRODUCT IN COMMERCE
73 sets.
DISTRIBUTION
LA, IN and MA.


PRODUCT
Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates. Catalog # 221267. Recall # Z-0345-3.
CODE
Lots: 2213201 EXP 11/25/02 2213211 EXP 11/26/02 2261524 EXP 1/14/02 2246310 EXP 1/1/03 2261552 EXP 1/15/03 2276445 EXP 1/29/03.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Sparks, MD, by fax on November 18, 2002. Firm initiated recall is ongoing.
REASON
Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species.
VOLUME OF PRODUCT IN COMMERCE

6422 cartons/100 plates per carton.
DISTRIBUTION
Nationwide and Internationally.

 

PRODUCT
FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599, 2007-01. Recall # Z-405-3.
CODE
049007 and 041599.
RECALLING FIRM/MANUFACTURER
Ciba Vision Corporation, Duluth, GA, by letter on December 16, 2002. Firm initiated recall is ongoing.
REASON
Mislabeling.
VOLUME OF PRODUCT IN COMMERCE
Specified.
DISTRIBUTION
Nationwide and Australia, Canada.

 

WEEK ENDING JANUARY 31

 

PRODUCT
IMx Glycated Hemoglobin Reagent Sets, list 1A86-88;
the set is composed of the IMx Gylcated Hemoglobin Reagent Pack, list 1A86-20, which contains 1 bottle (10.5 mL)Polyanion Affinity Reagent, 1 bottle (11.1 mL) Lysis Reagent, 1 bottle (10.5 mL) Sorbitol in buffer and 1 bottle (28.0 mL) Wash Buffer, and 1 box (100) Ion Capture Reaction Cells, list 5A57-01. Recall # Z-0445-3.
CODE
lot numbers 85129M200, 85129M201, 85128M200, 83668M200, 85127M200, 84879M100, 84880M100, 84876M100, 84876M101, 83669M200, 83667M200, 83666M200, 83665M200, 82339M200, 82338M200, 82337M200, 75768M300, 75767M300, 75766M300.
RECALLING FIRM/MANUFACTURER
Abbott laboratories, Inc., Abbott Park, IL, by letters dated July 2, 2002. Firm initiated recall is ongoing.
REASON
Low Control reads high, out of insert range.
VOLUME OF PRODUCT IN COMMERCE
38,877 kits.
DISTRIBUTION
Nationwide and Internationally.