FEBRUARY 2005
WEEK ENDING FEBRUARY 5
PRODUCT
Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm
Part Numbers: 234-010-078; 234-010-080.
CODE
Lot # 32101; Lot # 32103.
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA.
REASON
The label on the outside of the shipping box has an incorrect description of
the screw diameter.
VOLUME OF PRODUCT IN COMMERCE
16 units of 078, 284 units of 080.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Hill-Rom brand VersaCare Bed; product P3200.
CODE
All serial numbers distributed prior to November 22, 2004.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN.
REASON
A potential trip hazard exists when the fracture frame adaptor bracket is installed
on the bed without the fracture frame.
VOLUME OF PRODUCT IN COMMERCE
324 units.
DISTRIBUTION
Nationwide.
PRODUCT
a) VAXCEL PASV Peripherally Inserted Central
Catheter, 3F, single lumen. Catalog #45-450,
UPN #M001454500; sold as individual catheters.
DEVICE DESCRIPTION: A radiopaque, polyurethane
catheter with a hub/suture wing, polyurethane
extension leg(s) and luer locking adapter(s).
A peel away sheath introducer allows for
percutaneous insertion of the catheter.
The hub/suture wing promotes fixation of the
catheter hub to the patient's skin.
b) VAXCEL PASV Peripherally Inserted Central
Catheter, 3F, single lumen, sold in a kit,
Catalog #45-451, UPN #M001454510, DEVICE
DESCRIPTION: A radiopaque, polyurethane
catheter with a hub/suture wing, polyurethane
extension leg(s) and luer locking adapter(s).
A peel away sheath introducer allows for
percutaneous insertion of the catheter. The
hub/suture wing promotes fixation of the
catheter hub to the patient's skin. Each KIT
contains catheter, cap; tape measure, 60 cm
length; stylet; stylet guide/flush assembly;
attachable suture wing; StatLock Catheter
Securement Device, Instructions for Use;
Peelaway Sheath Introducer; 10 mL Syringe;
CSR Wrap.
c) VAXCEL PASV Peripherally Inserted Central
Catheter, 3F, single lumen, sold in a kit,
Catalog #45-452; UPN #M001454520. DEVICE
DESCRIPTION: A radiopaque, polyurethane
catheter with a hub/suture wing, polyurethane
extension leg(s) and luer locking adapter(s).
A peel away sheath introducer allows for
percutaneous insertion of the catheter. The
hub/suture wing promotes fixation of the
catheter hub to the patient's skin. Each
KIT contains: Catheter; caps; tape measure,
60 cm length;stylet; stylet guide/flush
assembly; attachable suture wing; statlock
catheter securement device; instructions for
use; 21 gauge, 1.5 inch introducer needle with
echogenic tip; 30 cm floppy tip guidewire; 5cm
peelable introducer sheath with locking dilator;
10 ml syringe; scalpel, CSR wrap.
d) VAXCEL PASV Peripherally Inserted Central
Catheter, 3F, single lumen, sold in kits,
Catalog #45-454, UPN #M001454540; DEVICE
DESCRIPTION: A radiopaque, polyurethane
catheter with a hub/suture wing, polyurethane
extension leg(s) and luer locking adapter(s).
A peel away sheath introducer allows for
percutaneous insertion of the catheter.
The hub/suture wing promotes fixation of
the catheter hub to the patient''s skin.
Each KIT contains: catheter; cap; tape measure,
60 cm length; stylet; stylet guide/flush
assembly; attachable suture wing; statlock
catheter securement device; instructions for
use; 21 gauge, 2.75 inch introducer needle with
echogenic tip; 60 cm guidewire with floppy tip
platinum tip; 10cm peelable introducer sheath
with locking dilator; 10 mL syringe, scalpel;
exact length measurement chart.
e) VAXCEL PASV Peripherally Inserted Central
Catheter, 3F, single lumen: CUSTOM KIT ‚ Catalog
#60M120521, UPN # M00160M1205210; DEVICE
DESCRIPTION: A radiopaque, polyurethane
catheter with a hub/suture wing, polyurethane
extension leg(s) and luer locking adapter(s).
A peel away sheath introducer allows for
percutaneous insertion of the catheter. The
hub/suture wing promotes fixation of the
catheter hub to the patient's skin.
f) PASV PICC CUSTOM KIT, 3F, single lumen ‚ Catalog
# 60M195071, UPN # M00160M1950710. DEVICE
DESCRIPTION: Each kit contains a radiopaque,
polyurethane catheter with a hub/suture wing,
polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer
allows for percutaneous insertion of the
catheter. The hub/suture wing promotes fixation
of the catheter hub to the patient's skin.
g) VAXCEL WITH PASV PICC, 3F, single lumen.
CUSTOM KIT - Catalog # 60M210624, UPN
#M00160M2106240. DEVICE DESCRIPTION:
Each kit contains a radiopaque, polyurethane
catheter with a hub/suture wing, polyurethane
extension leg(s) and luer locking adapter(s).
A peel away sheath introducer allows for
percutaneous insertion of the catheter. The
hub/suture wing promotes fixation of the catheter
hub to the patient's skin.
h) PASV PICC, 3F, single lumen, CUSTOM KIT.
Catalog #60M220991, UPN #M00160M2209910.
DEVICE DESCRIPTION: Each kit contains a radiopaque, polyurethane catheter with a
hub/suture wing, polyurethane extension leg(s)
and luer locking adapter(s). A peel away
sheath introducer allows for percutaneous
insertion of the catheter. The hub/suture
wing promotes fixation of the catheter hub
to the patient's skin.
CODE
a) 913404; 913661; 917962; 924521; 930616; 936038;
943745; 950540; 950969; 3010403046; 3010403102;
3010803014; 3010803015; 3010803016; 3010803178;
3011002259; 3011102034; 3011102035;
b) 933284;
c) 933285; 982726;
d) 913405; 924522; 930838; 939045; 950541; 977138;
982727; 3010303254; 3010403103; 3010403104;
3011002260; 3011002261; 3011102036; 3011102037;
e) 898658; 898990; 901923; 921920; 931621; 933875;
938673; 939255; 942560; 960665; 961989; 970713;
975113; 982649;
f) 876451; 880973; 895705; 895840; 902035; 904140;
912436; 914101; 917478; 920964; 924386; 930246;
933161; 936220; 937349; 941261; 944296; 950194;
951521; 952701; 953969; 956599; 959868; 961578;
963203; 966369; 970121; 977692; 980758; 983865;
985575;
g) 909873; 910390; 910849; 964847; 966372; 969263;
972284; 973904;
h) 975342.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Natick, MA.
REASON
Catheter separation immediately distal to the nose of the suture wing.
VOLUME OF PRODUCT IN COMMERCE
3,461 units.
DISTRIBUTION
Nationwide and Canada.
PRODUCT
a) Harvard 2 Dual Channel Syringe Infusion Pump
P/N 20001-001.
b) Harvard 1 Single Channel Syringe Infusion Pump
P/N 2003-001.
c) Harvard 2 Syringe Pump, Model Number 2005-001.
CODE
a) Serial number range: 208002251 - 408203175;
b) Serial number range: 308102012 - 408102213;
c) Serial number range 218002222 - 218002382
02R00222 - 02R002382 318002383 - 318002426.
RECALLING FIRM/MANUFACTURER
Harvard Clinical Technology, Natick, MA.
REASON
Potential pump motor/encoder assembly failure may cause over infusing medication
in patients.
VOLUME OF PRODUCT IN COMMERCE
1,334
DISTRIBUTION
Nationwide.
PRODUCT
B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR
Analyzers, List numbers 8C89-01 and 3M74-01.
CODE
All lots manufactured.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX.
REASON
Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on
the same analyzer due to carryover. B-12 results are not impacted.
VOLUME OF PRODUCT IN COMMERCE
6,860 units.
DISTRIBUTION
Internationally.
PRODUCT
Arctic Sun Temperature Management System. Catalog No. 2000-02 (115 volt) and
2000-03 (230 volt).
CODE
Serial numbers 3001 thru 3080.
RECALLING FIRM/MANUFACTURER
Medivance Inc., Louisville, CO.
REASON
Potential for an inaccuracy of the primary patient temperature reading that
is used to monitor and control patient temperature.
VOLUME OF PRODUCT IN COMMERCE
67 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
VISTA Brite Tip RDC(1) Guiding Catheter. Product Code 67021055, Percutaneous
Catheter..
CODE
Lot X0704002.
RECALLING FIRM/MANUFACTURER
Cordis Corporation, Miami Lakes, FL.
REASON
The product was manufactured such that the distal end had an "RDC" shape rather
than the "RDC(1)" shape. The RDC shape has a larger curve.
VOLUME OF PRODUCT IN COMMERCE
153 units.
DISTRIBUTION
Nationwide and Internationally.
FDA Issues Nationwide Alert on IV Flush Brand of Preloaded Syringes Containing Heparin or Sodium Chloride Intravenous Catheter Flushes
FDA is issuing a nationwide alert against the use of all lots of preloaded syringes containing either heparin or sodium chloride intravenous catheter flushes manufactured by the IV Flush, LLC and distributed by Pinnacle Medical Supply, of Rowlett, Texas, because these products have not received proper clearance from FDA and may be contaminated.
Consumers and institutions who have these preloaded syringes containing heparin or sodium chloride intravenous flushes should return them to the IV Flush, LLC or the original distributor.
The heparin and sodium chloride containing intravenous flushes were sold to distributors who redistributed to other medical distributors and hospitals. They can be identified by the syringe label, which reads in part: "IV Flush Dallas, TX."
IV Flush, LLC, is notifying its distributors by phone and letter and has requested those distributors contact their customers. The company is arranging for return of all recalled products.
Consumers with questions may contact the company at 1-972-463-7389. Persons wanting to report anything to the Food and Drug Administration regarding either of these products may contact FDA's MedWatch office at 1 800-FDA-1088.
WEEK ENDING FEBRUARY 12
PRODUCT
a) Bio Med Devices Patient Breathing Circuit
Catalog Number: 80011 Labeled in part:
":PATIENT BREATHING CIRCUIT =-=-=-= CONTENTS:
1-PATIENT HOSE 22mmIDx42" 1-PRESSURE GAGE
LINE 3/16"IDx54" 1-PATIENT HOSE 22mmIDx24"
3-ADAPTERS 22mm x 22mm 1-PATIENT HOSE 22mmIDx6"
1-ADULT PRESSURE TEE 1-EXHALATION VALVE w/HOLDING
ARM & 1-TEMPERATURE ADAPTER 22mmID x 22mm
COLLECTION HEAD 2-CUFF 1û4"ID x 5/4" 1-EXHALATION
VALVE LINE 1/8"IDx52"
b) Bio Med Devices Patient Breathing Circuit
Catalog Number: 80015 Labeled in part:
DO NOT REUSE DISPOSABLE DISPOSABLE PATIENT
BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-
CONTENTS: 1-PATIENT SMOOTH BORE HOSE 1-ADAPTER
22mmx22mm 22mmIDx72" w/CLIPS 1-ADULT PRESSURE
TEE w/.140 HOLE 1-LINE 1/8"IDx84" 1-TEE
1/8"x1/8"x1/8" 1-LINE 1/8"IDx24" 1-HOLDING
ARM 1-LINE 1/8"IDx2" 1-CUFF 1û4"IDx2".
c) Bio Med Devices Patient Breathing Circuit
Catalog Number: 8002A Labeled in part:
ONE SET - SINGLE USE CATALOG NO. 8002A PATIENT
BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-
CONTENTS: 1-PATIENT HOSE 22mmIDx42" 1-PRESSURE
GAGE LINE 1-PATIENT HOSE 22mmIDx6" 1-EXHALATION
VALVE w/HOLDING ARM& COLLECTION HEAD 48" w/CUFF
1û4"ID 1-ADULT PRESSURE TEE w/CUFF 1-EXHALATION
VALVE LINE 1/8"IDx48" 2-ADAPTERS 22mmx22mm.
d) Bio Med Devices Patient Breathing Circuit
Catalog Number: 8002A-7 Labeled in part: ONE
SET - SINGLE USE ATALOG NO. 8002A-7 PATIENT
BREATHING CIRCUIT =-=-=-=-=-=-=-=-CONTENTS:
1-PATIENT HOSE 22mmIDx60" 1-EXHALATION VALVE
LINE 1/8"IDx90" 1-PATIENT HOSE 22mmIDx18"
1-PATIENT HOSE 22mmIDx6" 1-PRESSURE GAGE LINE
84" w/CUFF 1û4"ID 1-EXHALATION VALVE w/HOLDING
ARM& COLLECTION HEAD 1-ADULT PRESSURE TEE
w/CUFF 3-ADAPTERS 22mmx22mm.
e) Bio Med Devices Patient Breathing Circuit
Catalog Number: 8002A-9 Labeled in part: ONE
SET - SINGLE USE CATALOG NO. 8002A-9 PATIENT
BREATHING CIRCUIT =-= CONTENTS: 1-PATIENT HOSE
22mmIDx60" 1-EXHALATION VALVE LINE 1/8"IDx108"
1-PATIENT HOSE 22mmIDx36" 1-PATIENT HOSE 22mmIDx6"
1-PRESSURE GAGE LINE 1-EXHALATION VALVE w/HOLDING
ARM&COLLECTION HEAD 102" w/CUFF 1û4"ID 1-ADULT
PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm.
f) Pneumotach, Disposable (B) Catalog Number:
4408 Labeled in part: SINGLE USE CATALOG NO.4408 PNEUMOTACH, DISPOSABLE (B) =-=-=-= CONTENTS: 1-
PNEUMOTACH HEAD ASSEMBLY 1- PARATUBE 60"2- TUBING
FITTINGS 1- 22x22mm ADAPTER.
g) Bio-Med Patient Breathing Circuit Product Number:
3030-5 Labeled in part: ONE SET - SINGLE USE
CATALOG NO. 3030-5 PATIENT BREATHING CIRCUIT =-=-=-
CONTENTS: 1-PATIENT HOSE 22mmIDx60" 1-PRESSURE GAGE
LINE 1/8"IDx72" 1-PATIENT HOSE 22mmIDx6"
1-EXHALATION VALVE w/COLLECTION HEAD 1-ADULT
PRESSURE TEE w/CUFF 1-EXHALATION VALVE LINE
1/8"IDx72 2-ADAPTERS 22mmx22mm.
h) Bio-Med Dental Breathing Circuit Product Number: DENTL. .
CODE
a) Lot Numbers: Last 6 digits 01092304, 01092404,
01092804, 01092904, 01093004, 01100504, 01100604,
01100704 01100804, 01101104, 01101204, 01101404,
01101504, 02101804, 01101904, 01102004 01102104,
01102204, 01102504, 05102504 01102604, 01102804,
01102904, 01110104 01110204, 01110504, 09111004,
01111104 05111204, 09111604, 01111704, 01111904
01112204, 09112404, 09113004, 09120204;
b) Lot Numbers: Last 6 digits 09092304, 09092404,
05092704, 02092804 01092904, 05093004, 01100104,
01100404, 01100504, 01101104, 01101204, 01101404,
01101804, 01102004, 01102104, 01102504 01102604,
09102704, 09102804, 09110104 09110204, 09110404,
05110804, 09111104 09111504, 01111604, 09111704,
09111804 02111904, 09112204, 09112304, 09112404
05112904, 09113004, 02120104, 09120204;
c) Lot Numbers: last 6 digits 09092204, 01092404,
05093004, 01100604 05100704, 02100804, 05101204,
01101804 09102804, 01110104, 09110404, 05110404,
05110904, 05111104, 09111604, 09111804 09111904,
09112204, 09112404, 05120104;
d) Lot Numbers: 05092304, 01092804, 01100104,
05100504 01100604, 05100704, 05101204, 01101304,
05102104, 01102504, 01102604, 09102704 09102804,
09110404, 01110404, 09110504 09110904, 02111004,
09111104, 09111204 09111504, 09112304, 09112904,
09113004 09120104;
e) Lot Numbers: 05092404, 01100404, 05100604,
05100704 05100804, 05101304, 05101404, 05101504,
05101904, 05102204, 05102804, 05110404 02110504,
05110804, 01110904, 05111204 05111504, 01111804,
05112204, 09120104;
f) Lot Numbers: 05092204, 05101104, 05101304,
05101404 05102004, 05102604, 05102804, 05110204,
05110304, 05110904, 05111804, 05112404 05120104;
g) Lot Number: 09111704;
h) Lot Number: 09110804.
RECALLING FIRM/MANUFACTURER
Bio-Med Devices, Inc., Guilford, CT.
REASON
Adapters may be occluded potentially preventing inhalation.
VOLUME OF PRODUCT IN COMMERCE
970 cases (20/cs).
DISTRIBUTION
Nationwide, and Internationally.
PRODUCT
Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed
for refilling the Medtronic SynchroMed family of pumps. The 8561 kit contains
a 1-20 ml ampule of 500 mcg/ml Baclofen injection along with a sterile refill
kit tray and sterile drug preparation tray. Lioresal drug ampules contained
witin Medtronic Lot N0016487 bear the primary manufacturer's label and lot number
007J2583. The drug box is labeled with Lot 017H1925. Medtronic packages a manufacturer's
labeled ampule into a protective drug box. A lot number and drug lot expiration
date are printed on the outside of the drug box. The filled and labeled drug
box is placed inside a larger kit assembly that contains other components necessary
to complete a pump refill. Only the large kit assembly ("Lioresal Refill
Kit") will display the Medtronic lot number (N0016487). The Model 8561
refill kit does not have a product code for itself; it is approved under PMA
P860004. PMA P860004 is classified as: pump infusion, implanted, programmable
under product code LKK.
CODE
N0016487.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Neurological & Spinal Division, Columbia Heights, MN.
REASON
Outer package of Lioresal Intrethecal Refill Kit, Model 8561, identifies the
kit to contain 1-20 ml ampule of baclofen injection for intrathecal administration,
500 mcg/ml (10 mg/20 ml). Lot N0016487 incorrectly contains 1-20 ml ampule of
baclofen concentration 2000 mcg/ml (40 mg/20 ml).
VOLUME OF PRODUCT IN COMMERCE
96 kits.
DISTRIBUTION
Nationwide.
PRODUCT Logix-CM Compounder Software, catalog 2M8400.
CODE
Software version 2.0.9 for Clintec Compounders.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare, Corp, Round Lake, IL.
REASON
A software anomaly in the Logix CM software could result in a drug mixture being
compounded without one of the ingredients if two drugs have the same indentifier
in Logix and another order entry program being used with the Logix software.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
MD, AZ, IN, OH, MN, PA, and Canada.
PRODUCT Logix-CM Compounder Software, catalog 2M8400.
CODE
Software version 3.0.4.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare, Corp, Round Lake, IL.
REASON Logix-CM software version 3.0.4 has not completed its official release process.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
AZ, UT, NC, WI, and CA.
PRODUCT
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000;
all series 1000 instruments labeled as System 1000, Altra Touch 1000, Baxter
Tina and Baxter Aurora.
CODE
All System 1000 Delivery System.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare, Renal Division, Mc Gaw Park, IL.
REASON
The air detector may not detect air bubbles consistently at the selected limit.
VOLUME OF PRODUCT IN COMMERCE
28,482 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
HomeChoice PRO Automated Peritoneal Dialysis Systems.
CODE
Units with software version 8.7 used with Physioneal Clear-Flex PD products.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Division, Mc Gaw Park, IL.
REASON
A software anomaly may allow concentrated solution to be infused into the patient
when the HomeChoice unit is used with Physioneal Clear-Flex PD products.
VOLUME OF PRODUCT IN COMMERCE
165 units.
DISTRIBUTION
Denmark and Sweden.
PRODUCT
Ultraview Universal Clinical Workstation System, Model 90385.
CODE SN: 385-000337 to SN: 385-111440 units with the specified Revision M or earlier
base which have not already been updated.
RECALLING FIRM/MANUFACTURER
Spacelabs Medical Inc., Issaquah, WA.
REASON
Weakness of the swivel base for the universal clinical workstation may result
in the unit falling from its mounted position endangering users and patients.
VOLUME OF PRODUCT IN COMMERCE
12,306 devices.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Harvard 2 Dual Channel Syringe Infusion Pump
P/N 2001-001.
b) Harvard 1 Single Channel Syringe Infusion Pump
P/N 2003-001.
CODE
a) Serial number range: 208002251 - 408203175;
b) Serial number range: 308102012 - 408102213.
RECALLING FIRM/MANUFACTURER
Harvard Clinical Technology, Natick, MA.
REASON
Potential pump motor/encoder assembly failure may cause over infusing medication
in patients.
VOLUME OF PRODUCT IN COMMERCE
1,334 units.
DISTRIBUTION
Nationwide.
PRODUCT
B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR
Analyzers. List numbers 8C89-01 and 3M74-01.
CODE
All lots manufactured.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX.
REASON
Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on
the same analyzer due to carryover B-12 results are not impacted.
VOLUME OF PRODUCT IN COMMERCE
6,860 units.
DISTRIBUTION
Internationally.
PRODUCT
Arctic Sun Temperature Management System, Catalog No. 2000-02 (115 volt) and
2000-03 (230 volt).
CODE
Serial numbers 3001 thru 3080.
RECALLING FIRM/MANUFACTURER Medivance, Inc., Louisville, CO.
REASON
Potential for an inaccuracy of the primary patient temperature reading that
is used to monitor and control patient temperature.
VOLUME OF PRODUCT IN COMMERCE
67 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.
CODE
Lot no. X1004212.
RECALLING FIRM/MANUFACTURER
Cordis Corp., Miami Lakes, FL.
REASON
Six of 370 stents released to market had a slightly below the required polymeric
coating weight. All other specifications were met.
VOLUME OF PRODUCT IN COMMERCE
300 units.
DISTRIBUTION
Nationwide.
PRODUCT
a) The Hospira Plum A + I.V. Infusion pump is a
cassette-based, multi-function fluid delivery
infusion system, consisting of pumping module and
assortment of IV sets.
b) The Hospira Plum A + 3 I.V. Infusion pump is a
cassette-based, multi-function fluid delivery
infusion system, consisting of pumping module and
assortment of IV sets.
CODE
a) All lots (serial numbers) are currently under
recall. List No 11971-04 and List No. 12391-04.
b) All lots (serial numbers) are currently under
recall. List No 12618-04 and List No. 12348-08.
RECALLING FIRM/MANUFACTURER Hospira, Inc., Morgan Hill, CA.
REASON
The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely
when the pump is operating solely on battery power.
VOLUME OF PRODUCT IN COMMERCE
31,914 units.
DISTRIBUTION
Nationwide and Internationally.
WEEK ENDING FEBRUARY 19
PRODUCT
Platelets.
CODE
Unit J08361.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI.,
REASON
Blood product, which was manufactured from a whole blood unit in which the associated
red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Source Plasma.
CODE
Unit numbers: 02OWIF8936, 02OWIF9969, 02OWIG0416.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Oshkosh, WI.,
REASON
Blood products, collected from a donor who had received MMR vaccine prior to
donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Austria.
PRODUCT
Fresh Frozen Plasma.
CODE
Unit number 6207723.
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ.,
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE
a) and b) Unit numbers FG97141, LE89604.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence,
RI.
REASON
Blood products, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MI, RI, and NY.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: 0662304.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA.
REASON
Blood product, collected from a donor who did not have a hematocrit or hemoglobin
test performed during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: 261185685.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR.
REASON
Blood product, collected using a hematocrit centrifuge that did not have quality
control performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 18V62680.
RECALLING FIRM/MANUFACTURER
American Nation Red Cross, Great Lakes Region, Lansing, MI.
REASON
Blood product, collected from a donor who did not have a hemoglobin test during
the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 18GM14239.
RECALLING FIRM/MANUFACTURER
American Nation Red Cross, Great Lakes Region, Lansing, MI.
REASON
Blood product, collected from a donor who did not have a hemoglobin test during
the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
a) Platelets, Leukocytes Reduced.
b) Cryoprecipitated AHF.
c) Fresh Frozen Plasma.
d) Plasma, Cryoprecipitate Reduced.
Recall # B-0554-5.
a) Unit 11GR41559;
b) Units 11FF84655, 11GL56432, 11GT44260,
11FW01586, 11FY19538, 11GW37928, 11GY28128,
11GV49410, 11FZ51078, 11GF35711, 11GW40541,
11FM82085;
c) Units 11GQ48977, 11GG22094, 11GT44209;
d) Units 11FF84655, 11LJ80341, 11FW01586,
11FY19538, 11GY28128, 11GV49410, 11FZ51078,
11KE39913, 11GV50515, 11GF35711, 11GW40541,
11FM82085.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Missouri-Illinois Region, St. Louis, MO.
REASON
Blood products, associated with units of Red Blood Cells that contained clots,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 units.
DISTRIBUTION
AL, AK. IL, GA, MO, OK, TN, and PR.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 33GR63495.
RECALLING FIRM/MANUFACTURER
American Nation Red Cross, Connecticut Region, Farmington, CT.
REASON
Blood product, collected from a donor who had lived in an area designated as
endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.
PRODUCT
Source Plasma.
CODE
Unit numbers: 51188702, 51180645, 39865724, 39845245, 39841193, 39822437, 39818829,
39810144, 39805799, 39797636, 39790842, 39782007, 39774132, 39771247, 39762955,
and 39758354.
RECALLING FIRM/MANUFACTURER
ZLB Bioplastic, Inc, Medford, OR.,
REASON
Blood products, collected from a donor with a history of body piercing, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number LK98270.
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA.
REASON
Blood products, collected from an ineligible donor due to a reported history
of Hepatitis C, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA and Switzerland.
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced
Irradiated.
CODE
a) Unit numbers 2013896, 2011743, 2010157,
and 2007667;
b) Unit numbers 2005997 and 2001553.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood products, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
TN.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated.
b) Platelets.
CODE
a) and b) Unit number 2043842.
RECALLING FIRM/MANUFACTURER
Medic, Inc. Knoxville, TN.
REASON
Blood products, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers 2015686 and 2023382.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood products, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 2515035.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 2029927.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 18GC25187.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Lansing, MI
REASON
Blood product, which was collected from a donor in which the hematocrit result
was not documented on the blood donation record, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Red Blood Cells.
CODE
Unit number J74486.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI.
REASON
Blood product, which was collected from a donor who had traveled to a malarial
endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
a) Fresh Frozen Plasma.
b) Recovered Plasma.
CODE
a) Unit R11475;
b) Unit S77924.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI.,
REASON
Blood products, which were collected from a donor who was at increased risk
for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI, and Switzerland.
PRODUCT
Red Blood Cells
CODE
Unit L59363.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI
REASON
Blood product, which was collected from a donor who had traveled to a malarial
endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
c) Cryoprecipitated AHF,
CODE
a) Units FH33677 and KS29554;
b) Unit KS29554;
c) Unit FH33677.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, VA
REASON
Blood products, which were collected from a donor who was at risk for Creutzfeldt-Jakob
Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MD and VA.
PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a) Units KT32875, KT26949, KT14157, and KT19784;
b) Units KT19784 and KT14157;
c) Units KT32875, KT19784, and KT14157;
d) Unit KT26949.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, VA
REASON
Blood products, which were collected from a donor who was at risk for Creutzfeldt-Jakob
Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
VA, and Switzerland.
PRODUCT
Red Blood Cells.
CODE
Unit FW23828.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, VA
REASON
Blood product, which was collected from a donor who had lived in a malarial
endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 231453457.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Billings, MT
REASON
Blood product, which was incorrectly tested and labeled as negative for the
Kell antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WY.
PRODUCT
Platelets, Irradiated.
CODE
Unit number 0799631.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, Irwin Center, San Francisco,
CA
Manufacturer: Blood Centers of the Pacific, North Bay Center, Fairfield, CA.
REASON
Blood product that was removed from controlled storage for more than allowed
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 04KT65714.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA
REASON
Blood product, collected from an ineligible donor due to a history of a chronic
ulcerative condition, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VT.
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
Unit 5403969.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ
REASON
Platelets, possibly contaminated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced Irradiated.
CODE
Unit number 2048005 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN
REASON
Blood products, that were found to be out of specification for red blood cell
recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
Fresh Frozen Plasma.
CODE
Unit 18GC25141.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Lansing, MI
REASON
Blood product, which did not have the collection time documented on the blood
donation record, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
WEEK ENDING FEBRUARY 26
PRODUCT
Advanced D-Dimer. Fibrinogen and fibrin split products, Catalog numbers OQWM11
AND OQEM13.
CODE
Lot numbers 544531 to 544548 and 544502 to 544504.
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE
REASON
Decrease in product stability after reconstitution and reduced stability on
board certain instrument systems.
VOLUME OF PRODUCT IN COMMERCE
25,381 units.
DISTRIBUTION
Nationwide.
PRODUCT
Most Options System Porous and Non-Porous Revision Stem Adapters. Catalog Numbers:
5000-50-100 and 5000-50-200.
CODE
Lot Numbers: 1529444, 1536181, 1538936, 1538937, 1542189, 1568350, 1568351,
1569597, 1596886, 1596890, 1601839, 1601841, 1610470, 1616609, and 1617691.
RECALLING FIRM/MANUFACTURER
Zimmer Austin, Inc., Austin, TX.
REASON
Risk of adapter disassociation from mating components when assembled improperly
or when subjected to high-stress femoral applications.
VOLUME OF PRODUCT IN COMMERCE
121 units.
DISTRIBUTION
AZ, CA, NY, IL, FL, MD, OH, MI, WI, MO, TX, Canada and Portugal.
PRODUCT
UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right,
Size 3, 10mm.
CODE
All of specific lot 044843.
RECALLING FIRM/MANUFACTURER
Plus Orthopedics, San Diego, CA.
REASON
Knee tibial insert is mislabeled completely as different device.
VOLUME OF PRODUCT IN COMMERCE
24 units.
DISTRIBUTION
CA, ID, IL, WI, and OR.
PRODUCT
Rapid Syphilis Test Kit, per insert, contents of the kit are 1 Rapid Syphilis
test cassette, 1 alcohol swab, 1 buffer container, 1 lancet (needle), 1 zipped
bag, 1 pipette (plastic) (included with cassette). There is no firm identified
on the product packaging.
CODE
All lots are subject to recall.
RECALLING FIRM/MANUFACTURER
Ups Supply Chain Solutions, Alpharetta, GA
REASON
The kits are not approved for use in the United States.
VOLUME OF PRODUCT IN COMMERCE
79 kits.
DISTRIBUTION
Nationwide.
PRODUCT
IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB 2, L2KVB6.
CODE
Kit lot 186 only.
RECALLING FIRM/MANUFACTURER
Diagnostic Products, Corp, Los Angeles, CA
REASON
A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin
B12 L2KVB 2, 6 kit lot 186 only.
VOLUME OF PRODUCT IN COMMERCE
189 kits.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Legionella ELISA Test System. The Is-Legionella IgG/IgM/IgA test kits are packaged
in cardboard boxes with individual components secured within a foam insert.
CODE
Lot # 91803Z and 30804/30804Z.
RECALLING FIRM/MANUFACTURER
Diamedix Corp., Miami, FL
REASON
The kits may lose activity, after one or two usages, causing the OD values for
the Cut-Off Calibrator and/or Positive Control to be recovered below their specified
ranges.
VOLUME OF PRODUCT IN COMMERCE
178 kits.
DISTRIBUTION
Nationwide.
PRODUCT
Waterlase MD, dental laser unit, Model #6200218.
CODE
Serial Numbers: 10500210 to 10502680,inclusive.
RECALLING FIRM/MANUFACTURER
Biolase Technology, Inc., San Clemente, CA
REASON
Reports that the Waterlase MD, a dental laser unit, water bottle broke under
pressure during installation.
VOLUME OF PRODUCT IN COMMERCE
209 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons
containing 6 lenses each. Cartons/blister packs are labeled with --3.25 DS,
-1.25DC, 170 degree Axis.
CODE
Carton lot: W44090230; Blister Lot W44089478.
RECALLING FIRM/MANUFACTURER
Bausch & Lomb, Inc., Rochester, NY
REASON
Portion of lot contains lenses with incorrect refractive power.
VOLUME OF PRODUCT IN COMMERCE
798/6 packs.
DISTRIBUTION
Nationwide.
Medtronic Announces Voluntary Recall of Certain Monophasic LIFEPAK 500 Automated External Defibrillators
Medtronic, Inc. (NYSE: MDT) today announced that it is voluntarily recalling a limited number of LIFEPAK 500 automated external defibrillators (AEDs). The AED may continue to display a "connect electrodes" message and may not analyze the patient's heart rhythm even when the electrodes are properly connected. Failure to analyze the patient's heart rhythm will inhibit defibrillation, if it is needed. This action affects 1,924 first-generation LIFEPAK 500 AEDs that were manufactured in 1997, which represents approximately 1 percent of LIFEPAK 500 AEDs currently in use worldwide. This action does not affect any other LIFEPAK 500 AEDs currently produced, or any other LIFEPAK product.
Medtronic distributed notices via certified mail on Feb. 3, 2005, to customers who purchased AEDs in this group of devices. The company will update or upgrade customer devices at no charge by March 31, 2005. The affected AEDs may remain in service and customers are currently being contacted with recommendations for use and replacement schedules. Only certain monophasic LIFEPAK 500 AEDs manufactured in 1997 are included in this action. Customers with further questions about this issue should call 1-877-873-7630 or visit www.medtronic-ers.com/500 to determine if their device is included in the action.
Medtronic is voluntarily recalling the affected AEDs.
The LIFEPAK 500 is used by first responders such as firefighters, police and others trained in
CPR/AED use and are first to arrive at the scene of a cardiac incident but do not have significant medical training.
Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its internet address is www.medtronic.com.