FEBRUARY 2003

 

 

WEEK ENDING FEBRUARY 8

 

PRODUCT
Hex-Lock Abutment, 2.5 mm Diameter. This medical device is designed for use in the firm's Sulzer Dental Implant Systems for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The abutment is screwed onto an endosseous dental implant, protrudes through the gingiva and is attached to the prostheses or fabricated tooth. The catalog numbers affected are HLA3/4. The devices are labeled sterile.
CODE
Lot 012239, Exp Date 7/2006
RECALLING FIRM/MANUFACTURER Sulzer Dental Inc
REASON Sterility
VOLUME OF PRODUCT IN COMMERCE 1
DISTRIBUTION PA


PRODUCT
a) 0.9% Sodium Chloride Flush Syringe, 30 syringes per case.
b) 10 U/mL Heparin Lock Flush Solution USP, 5mL in 12 mL  Syringe, 30 syringes per case

c) 100 U/mL Heparin Lock Flush Solution USP; 30 syringes per case.
CODE
a) All lots within expiration date of the following pre-filled syringes:
Code 2K0901: 2 mL in 3 mL syringe
Code 2K0903: 3 mL in 6 mL syringe
Code K0905: 5 mL in 12 mL syringe
Code 2K0906: 10 mL in 12 mL syringe
Code 2K6011: 2 mL in 3 mL syringe w/cannula
Code 2K6012: 3mL in 6 mL syringe w/cannula
Code 2K6013: 5 mL in 12 mL syringe w/cannula
Code 2K6014: 10 mL in 12 mL syringe w/cannula.
b) Code 2K6030, All lots within expiration date.
c) All lots within expiration date of the following pre-filled syringes:
Code 2K6049: 3 mL in 12 mL syringe
Code 2K6050: 5 mL in 12 mL syringe
Code 2K6058: 5 mL in 12 mL syringe w/cannula.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL.,
Manufacturer: Baxter Healthcare Corporation, Deerfield, IL.
REASON Sterility questioned.
VOLUME OF PRODUCT IN COMMERCE
a) 51,052,140 syringes;
b) 388,080 syringes;
c) 727,560 syringes.
DISTRIBUTION Nationwide, Canada, Honduras, Indonesia and Israel.

PRODUCT
a) Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a 0 neck length on Co-Cr 12/14 tapers. Cat. No. 6418-26-02.
b) Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.0 neck length on Co-Cr 12/14 tapers. Cat. No. 6418-26-03.

c) Zimmer Alumina ceramic femoral head; 26 mm diameter  alumina head with a +3.5 neck length on Co-Cr tapers. Cat. No. 6418-28-03

CODE All lots.
RECALLING FIRM/MANUFACTURER Zimmer Inc., Warsaw, IN
REASON Compression test results are not in accordance with device approval submission.
VOLUME OF PRODUCT IN COMMERCE 362.
DISTRIBUTION Nationwide.


PRODUCT
a) Premier brand C. difficile Toxin A, diagnostic test kits, one kit per pouch, one pouch per shipping box.
b) Premier brand Toxins A. & B, diagnostic test kits, one kit per pouch, one pouch per shipping box.
c) Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box.
 
CODE
a) Lot #601096.180, Exp Date 27 SEP 03; Kit Catalog #601096.
b) Lot #616096.053, Exp Date 23 JUL 03; Lot #616096.055, Exp Date 23 JUL 03; Lot #616096.056, Exp Date 23 JUL 03; Kit Catalog #616096.
c) Lot #601348.069, Exp Date 22 SEP 03; Lot #601348.070, Exp Date 22 SEP 03; Kit Catalog #601348.
RECALLING FIRM/MANUFACTURER Meridian Bioscience Inc., Cincinnati, OH,

REASON Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE
a) 1,215 kits;
b) 1,409 kits;
c) 1,020 kits.
DISTRIBUTION Nationwide and Internationally.


PRODUCT Kendall Argyle 3.7 Fr Polyurethane Umbilical Vessel Catheter.

CODE Reference Number: 8888-160350 Lot Numbers: U14250, U15530, U15850, U16210, U16460, U16670, 423878.
RECALLING FIRM/MANUFACTURER Recalling Firm: Tyco Healthcare Group Lp/Kendall Mansfield, MA
Manufacturer: Kendall, a division of Tyco Healthcare Group LP Argyle, NY

REASON Lumen of Catheter may not accomodate the designated blood gas sensor.
VOLUME OF PRODUCT IN COMMERCE 734 cases (10/case).
DISTRIBUTION Nationwide.


PRODUCT
a) Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size ll,standard body. Cat. No. 7841-11-10. b) Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size l2,standard body. Cat. No. 7841-12-10

c) Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size l3,standard body. Cat. No. 7841-13-10

d) Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size l4,standard body. Cat. No. 7841-14-10

e) Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size l5,standard body. Cat. No. 7841-15-10

f) Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size l6,standard body. Cat. No. 7841-16-10. CODE All lots.
RECALLING FIRM/MANUFACTURER Zimmer, Inc., Warsaw, IN.
REASON The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
VOLUME OF PRODUCT IN COMMERCE 383
DISTRIBUTION Nationwide, Australia and Canada.

 


PRODUCT PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734..
CODE All PO2 electrodes are affected.

RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN

REASON Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results.
VOLUME OF PRODUCT IN COMMERCE  695.
DISTRIBUTION Nationwide.


PRODUCT
a) Roche/Hitachi Modular Analytics E 170 Module.
b) Roche/Hitachi Integrated MODULAR ANALYTICS E 170 Module.
CODE All units of all catalog numbers [7656961, 7657009, 7657021 and 7657900].
RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN

Manufacturer: Hitachi Ltd., Ibaraki-ken 312-8504, Japan.
REASON Fluid leak may cause smoke/damage analyzer.
VOLUME OF PRODUCT IN COMMERCE 116.
DISTRIBUTION Nationwide and Canada.

 


PRODUCT ComforTEC II Single Use pH Probe Latex Free. Packaged individually.

CODE All product models: C2NS, C2NS-P, C2NS-A, C2N5, C2N10, C2N15, C2N10-V, C2IS, C2I5, C2I10, C2I15, C2I10-V. All lot numbers: U02314 through U021216N-15G.
RECALLING FIRM/MANUFACTURER Sandhill Scientific, Inc., Highlands Ranch, CO

REASON Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.
VOLUME OF PRODUCT IN COMMERCE 6678 probes.
DISTRIBUTION Nationwide, Argentina, Canada, Chile, China, Ireland, Italy, Jordan, Malaysia, Netherlands and Spain.

 

WEEK ENDING FEBRUARY 15

 

***CORRECTION***

Enforcement Report for February 5, 2003, (03-06), the recall listing for Baxter's Sodium Chloride Flush and Heparin Lock Flush Syringes, Recall # Z-456/458-3 has Baxter, Deerfield, IL listed as the manufacturer, the correct manufacturer is Baxter, Nashville, TN.


PRODUCT Pulmonary heart valve allograft, human tissue for transplantation.
CODE 01-0293HV-02.
RECALLING FIRM/MANUFACTURER LifeNet, Virginia Beach, VA

REASON A heart valve from donor whose sera was found potentially positive for Hepatitis C, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 valve.
DISTRIBUTION NY.

PRODUCT Philips BV 300 Mobile X-Ray System.
CODE Part numbers 9896 000 06801 and 9806 000 06802 with serial numbers: DBXXXX - all DBXXXX - all DDXXXX - all DEXXXX - all DG0001-DG0129 DH0001-DH0033 DJ0001 - DJ0152 DK0001 - DK 0076.
RECALLING FIRM/MANUFACTURER Philips Medical Systems, Bothell, WA.,

 REASON The C-bow support can bend and break allowing C-arm to fall from support.
VOLUME OF PRODUCT IN COMMERCE 229 devices.
DISTRIBUTION Nationwide.

 

PRODUCT Spinal 26 Gauge Quincke with Bupivacaine, Epinephrine, and Lidocaine.
CODE List No. 3099-20 Lot No. 78-725-Z1, Expiration Date: July 1, 2003.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Abbott Park, IL.,

REASON Mis-stenciling on tray. Tray stenciled Saddle Block instead of Spinal.
VOLUME OF PRODUCT IN COMMERCE 2980 units.
DISTRIBUTION AR, CA, FL, MA, ME, NH, NM, PA, PR.

 


PRODUCT
a) Restoration #8 HA Hip Stem, Catalog No. 6013-1216;
b) Restoration #8 HA Hip Stem, Catalog No. 6013-1218.
CODE
a) Lot Code: 37778302;
b) Lot Code: 37778401.
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics, Mahwah, NJ

REASON Product mix-up. 16mm stem in a 18mm package.
VOLUME OF PRODUCT IN COMMERCE 6
DISTRIBUTION  FL, Chile and Spain.

 

WEEK ENDING FEBRUARY 22

 

PRODUCT

a) Baxter Vented Buretrol Volumetric Pump Solution Set,  10 drops/mL; catalog 1C8384; 10 units per case. 

b) Baxter Interlink System Minivolume Extension Set; catalog 1C8412. 

c) Baxter Y-Type Minivolume Extension Set; catalog 1C8499.

d) Baxter Interlink System Extension Set with 0.22 Micron  Filter, catalog 1C8546. 

e) Baxter Interlink System Vented Buretrol Solution Set, 10 drops/mL; catalog 1C8560. 

f) Baxter Interlink System Minivolume Extension Set with 0.22 Micron Filter, catalog 1C8577. 

g) Baxter Interlink System Buretrol Solution Set, 10 drops/mL; catalog 1C8633. 

h) Baxter Auto Syringe Micro-Volume Extension Set with 0.22  Micron Filter, catalog 1M8516 and 1M8516Y. 

i) Baxter Auto Syringe Micro-Volume Extension Set with 0.22  Micron Filter, catalog 1M8522 and 1M8522Y. 

j) Baxter Auto Syringe Micro-Volume Extension Set with 0.22  Micron Filter, catalog 1M8527 and 1M85827Y. 

k) Baxter Auto Syringe Extension Set with 0.22  Micron Filter, catalog 1M8529.

l) Baxter Minivolume T-Connector Extension Set with 0.22  Micron High Pressure Pediatric Filter, catalog 2C5683,

   48 units per case.

m) Baxter Minivolume Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5693, 48 units per case.

 n) Baxter Interlink System Microbore T-Connector Extension  Set with 0.22 Micron High Pressure Pediatric Filter,

   catalog 2N3332, 200 units per case.

o) Baxter Interlink System Microbore T-Connector Extension  Set with 0.22 Micron High Pressure Pediatric Filter,

   catalog 2N3333, 200 units per case.

p) Baxter Microbore 3-Lead Extension Set with 0.22 Micron  High Pressure Pediatric Filter, catalog 2N3342, 50 units

   per case.

q) Baxter 36" Micro-Volume Extension Set, catalog 2N3347.

r) Baxter 60" Micro-Volume Extension Set, catalog 2N3350.

s) Baxter Interlink System Minivolume Extension Set, catalog 1C8483. 

t) Baxter Interlink System Buretrol Solution Set, 60 drops/mL; catalog 1C8600. 

CODE All lots received prior to 10/23/2002.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Baxter Healthcare Corp., Round Lake, IL.,

Manufacturer:  Baxter Healthcare Corp., Deerfield, IL.

REASON The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

VOLUME OF PRODUCT IN COMMERCE

a) 2,064 units;

b) 679,968 units;

c) 13,104 units;

d) 0 units;

e) 21,972 units;

f) 1,920 units;

g) 4,908 units;

h) 16,860 units;

i) 53,310 units;

j) 0 units;

k) 0 units;

l) 198,816 units;

m) 634,992 units;

n) 47,000 units;

o) 265,240 units;

p) 130,040 units;

q) 247,800 units;

r) 630,140 units;

s) 74,832 units;

t) 9,072 units.

DISTRIBUTION Nationwide and Internationally.

 

***CORRECTION***

Enforcement Report for February 12,2003, (03-07), the recall listing for Spinal 26 Gauge Quincke with Bupivacaine, Epinephrine, and Lidocaine, Recall # Z-0527-03 has Abbott Laboratories, Abbott Park, IL listed as the Recalling Firm/Manufacturer, the correct Recalling Firm/Manufacturer is Abbott Laboratories, Laurinburg, NC.

 

PRODUCT X-Cel MB-700 A/C Podiatry X-Ray System. 

CODE Model Number:  MB-700 A/C.

RECALLING FIRM/MANUFACTURER X-Cel X-Ray Corporation, Crystal Lake, IL

REASON The X-Ray system contained a defective X-Ray tube shield.

VOLUME OF PRODUCT IN COMMERCE 6 units.

DISTRIBUTION Nationwide.

 

PRODUCT

a) Venus Eye Sphere 12 mm (Sterile).

b) Venus Eye Sphere 14 mm (sterile). 

c) Venus Eye Sphere 16 mm (sterile).

d) Venus Eye Sphere 18 mm (sterile).

e) Venus Eye Sphere 20 mm (sterile). 

f) Venus Eye Sphere 22 mm (sterile). 

g) Conformer Small (sterile). 

h) Conformer Medium (sterile.)

i) Conformer Large (sterile). 

j) Conformer Small with holes (sterile). 

k) Conformer Medium with holes (sterile). 

l) Conformer Large with holes (sterile). 

m) Venus Eye sphere 10 mm (Sterile).  

CODE

a) Model Number 14151, lot number 8284;

b) Model Number 14152, lot number 8447;

c) Model number 14153, lot numbrt 8159;

d) Model number 14154, lot number 8447;

e) Model number 14155, lot number 8404;

f) Model number 14156, lot number 8447;

g) Model number 14164, lot number 8264B;

h) Model number 14165, lot number 1187;

i) Model number 14166, lot number 1218;

j) Model number 14167, lot number 1233;

k) Model number 14168, lot number 1234;

l) Model number 14169, lot number 1235;

m) Model number 14150, lot number 7381.

RECALLING FIRM/MANUFACTURER

Gulden Ophthalmics, Elkins Park, PA.,

REASON Lack of sterility assurance.

VOLUME OF PRODUCT IN COMMERCE 1096 units.

DISTRIBUTION Nationwide and New Zealand.

 

PRODUCT Coulter LH 700 Series Hematology Analyzers. 

CODE All lots.

RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA

REASON Biohazard situation exists for users.

VOLUME OF PRODUCT IN COMMERCE 210.

DISTRIBUTION Nationwide and Canada.

 

PRODUCT Lifepak 12 defibrillator/monitor is a portable battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation.

CODE All LIFEPAK 12 units are affected.

RECALLING FIRM/MANUFACTURER Medtronic Physio Control Corp., Redmond, WA,

REASON Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAk 12 unit.

VOLUME OF PRODUCT IN COMMERCE 46,042.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Synchron LX20 and LX20 Pro. 

CODE All serial numbers.

RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.,

REASON The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence.

VOLUME OF PRODUCT IN COMMERCE 1001.

DISTRIBUTION Canada and Nationwide.

 

PRODUCT Radiopaque bone cement, 40 gram.  Product number 424800. 

CODE All lots.

RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN.,

REASON There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer.

VOLUME OF PRODUCT IN COMMERCE 301,226 units.

DISTRIBUTION Nationwide.

 

PRODUCT Zoll AED Plus Defibrillator (Automatic External Defibrillator). 

CODE Serial Numbers:  X02F000812 through X02K007486.

RECALLING FIRM/MANUFACTURER Zoll Medical Corp., Burlington, MA.,

REASON Defibrillator may fail to function due to false detection of safety fault condition.

VOLUME OF PRODUCT IN COMMERCE 5,597 units.

DISTRIBUTION Nationwide.

 

PRODUCT

a) Boston Scientific/Microvasive Rapid Exchange retrieval  Balloon/8.5 mm balloon, Catalog #4544. 

b) Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon, Catalog #4545. 

c) Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/15.5 mm balloon, Catalog #4546. 

CODE

a) Lot Number:  5173906;

b) Lot Numbers:  5175575 5185073 5185074 5185075 5193211, 5193212 5193213 5193920 5196902;

c) Lot Number:  5184800.

RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Natick, MA.,

REASON Breach in sterile barrier may compromise sterility.

VOLUME OF PRODUCT IN COMMERCE

a) 22 units;

b) 255 units;

c) 30 units.

DISTRIBUTION Nationwide.

 

PRODUCT 25 Gauge Hydrodissection Cannula 1" (25 mm) with U-Shaped Flattened End. 

CODE  Model Number of Device:  3425, Catalog Number:  3425, Lot Number:  MK10190 exp 11/2006.

RECALLING FIRM/MANUFACTURER Surgical Specialties Corp., Reading, PA.,

REASON The wrong product in the box.

VOLUME OF PRODUCT IN COMMERCE 211 units.

DISTRIBUTION CA, Spain and Australia.

 

PRODUCT

a) Ascension PIP, Prosthesis, finger, semi-constrained,  pyrolytic carbon, uncemented.  The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005.  Recall # Z-0549-03;

b) Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal. 

CODE

a) Removal domestically of literature Document:  LC-04-207-001.

b) Brochure intended for international distribution, Document:  LC-04-107-011.

RECALLING FIRM/MANUFACTURER Ascension Orthopedics, Inc., Austin, TX.,

REASON Brochures approved for international distribution only were distributed domestically.

VOLUME OF PRODUCT IN COMMERCE Unknown.

DISTRIBUTION Nationwide.