FEBRUARY
2001
WEEK ENDING FEBRUARY 2
PRODUCT: Medtronic BioMedicus Adult Femoral Cannula:
a) Bio-Medicus arterial percutanious cannula
kits.
b) Bio-Medicus arterial percutanious cannula
kits.
c) Bio-Medicus arterial percutanious cannula kits.
d) Bio-Medicus arterial percutanious cannula kits.
e) Bio-Medicus venous percutanious cannula
kits.
f) Bio-Medicus venous percutanious cannula
kits.
g) Bio-Medicus venous percutanious cannula
kits.
h) Bio-Medicus venous percutanious cannula
kits.
i) Bio-Medicus adult venous cannulae with introducer
and 1/2 inch non-vented connector.
j) Bio-Medicus adult venous cannulae with introducer
and 1/2 inch non-vented connector.
k) Bio-Medicus adult venous cannulae with introducer
and 1/2 inch non-vented connector.
l) Bio-Medicus adult venous cannulae with introducer
and 1/2 inch non-vented connector.
CODE:
a) Product Code 96530-015; b) Product Code
96530-017;
c) Product Code 96530-019; d) Product Code
96530-021;
e) Product Code 96600-015; f) Product Code
96600-017;
g) Product Code 96600-019; h) Product Code
96600-021;
i) Product Code 96370-023; j) Product Code
96370-025;
k) Product Code 96370-027; l) Product Code
96370-029.
MANUFACTURER: Medtronic Sterile Systems,
Inc., Grand Rapids, MI.
DISTRIBUTION: US, Australia, Canada,
Latin America, the Netherlands.
QUANTITY: 345 units in the US, 17
internationally, also affected are 893 units that remain under Medtronic
control, total 1347.
REASON: Difficulty in inserting
the recommended 0.038 inch guidewire into the tip end of the introducer.
PRODUCT: a) Zimmer Trilogy Acetabular System Eccentric
Liner, 32mm I.D.,10 Degree Oblique Face for use with 70mm O.D. Shell, Catalog
No. 00-6151-070-32. b Zimmer Trilogy Acetabular System Eccentric Liner, 32 mm
I.D., 10 Degree Oblique Face for use with 72 mm O.D. Shell Catalog No.
00-6151-072-32,
CODE: a)Lot No. 35031200; b) Lot
No. 35031300.
MANUFACTURER: Zimmer, Inc., Warsaw, IN.
DISTRIBUTION: Ohio, Illinois, Michigan, California,
Maryland, Oregon, Florida and Arizona.
QUANTITY: 36 units manufactured, 32
units distributed (16 of each lot).
REASON: 70 mm liner inside a 72 mm
package.
PRODUCT: a)Sensolog III Pulse Generator, Model No. 2033. b)
Dialog II Pulse Generator, Model No. 2037.
CODE: Sensolog III model 2033
and Dialog II model 2037. All serial
numbers.
MANUFACTURER: Siemens-Elema AB Sweden.
RECALLED BY: St. Jude Medical, Inc.,
Sylmar, CA.
DISTRIBUTION: Bethesda Naval Hospital in
Bethesda, MD, VA facilities in AL, FL, GA, IA, ND, SC, TN. To physicians nationwide.
QUANTITY: 367 active implants in US,
plus 123 lost to follow-up.
REASON: A corrosion bridge forms
across the feedthrough inside the battery resulting in a sudden decrease of
cellvoltage.
PRODUCT: Cryovalve Allograft
CODE: a) Model No. AVOO, Serial
Nos. 3803473, 6280099. b) Model No.
PVOO, Serial No. 3803465.
MANUFACTURER: Cryolife, Inc., Kennesaw,
GA.
DISTRIBUTION: Portland, Or; Roslyn, NY,
and Boston, MA.
QUANTITY: 3 valves.
REASON: Did not meet the current
guidelines regarding serodilution of plasma because of the amount of
transfused/ infused fluids administered.
PRODUCT: TheraSeed Palladium 103 (Pd-103) Seeds.
CODE: Model 200, Lot 0039D.
MANUFACTURER: Theragenics Corp.,
Norcross, GA.
DISTRIBUTION: CO, FL, IA, KY, LA, NJ,
NY, PA, SD, TN, WA.
QUANTITY: 13
REASON: Improperly labeled Pd-103
sources may lead to inappropriate exposure of the patient to radiation with the
potential for a misadministration of radiation therapy.
PRODUCT: ION Implanted Femoral Bearing Head.
CODE: Lot 58486201.
MANUFACTURER: Howmedica Osteonics Corp,
Allendale, NJ
DISTRIBUTION: Nationwide.
QUANTITY: 12
REASON: Package labeled as a
06-2800, Lot 58486201, Osteonics C-Taper + 0
Head actually contained a 06-28056201,Oseonics C-Taper + 5 Head.
PRODUCT: Roche Creatinine Mira, Catalog No.3033414.
CODE: Lot No. A12071, Exp.
September 2002.
MANUFACTURER: Raichem, division of
Hemagen, San Diego, CA.
RECALLED BY: Roche Diagnostics Corporation,
Indianapolis, IN
DISTRIBUTION: Nationwide.
QUANTITY: 2550 pieces.
REASON: Package insert, contained
in the kit, was printed with an incorrect reagent volume for COBAS MIRA
analyzers using software Version 8735.
WEEK
ENDING FEBRUARY 9
PRODUCT: Gelfoam Sterile Powder, 1 g jar; Gelfoam Sterile Sponge, Dental Pack
- Size 4, Gelfoam Sterile Sponge, Size 2 cm and Size 12-7 mm.
CODE: All lots.
MANUFACTURER: Pharmacia Corporation, Kalamazoo, MI.
DISTRIBUTION: United States, Canada, United Kingdom,
Japan, Aruba, Barbados, Bermuda, Curacao, Grand Cayman, Haiti, Jamaica, Puerto
Rico, St. Lucia, Singapore, Ireland, Australia, Belgium, Egypt, Saudi Arabia,
Jordan, Korea, New Zealand, Taiwan, Chile, Panama, Costa Rica, Brazil, and
Cyprus.
QUANTITY: 1,505,802 units were distributed between 10/95 and
10/00.
REASON: Aluminum shavings or fragments from the lid liner
of the jar.
PRODUCT: Model Smoothlase Alexandrite
Laser System.
CODE: Serial Nos. 019 thru 023, 025-026, 028-029.
MANUFACTURER: Cooper Surgical of Shelton, CT.
DISTRIBUTION: NY, CA, VA, NJ, AR, ID and IL.
QUANTITY: 9 units
REASON: Lasers lacked certain required procedures and
labels.
PRODUCT: I Stat Systems a)I Stat CG-4+, Catalog No. 220500, b) Abbott
Laboratories, Catalog Nos. 7G02-01, 7G02-02.
CODE: Abbott Lot Nos. P00263.00275, P00280.
MANUFACTURER: I-Stat Corp., Windsor, NJ.
DISTRIBUTION: Ohio, Tenn., Florida, Washington, D.C.,
Iowa, and Hong Kong, Singapore, Japan, and Australia
QUANTITY: 9100 cartridges.
REASON: The calibration fluid contained in most if not all
cartridges in the three affected lots, has a low and out of specification
concentration of lactic acid used to calibrate the lactate test.
PRODUCT: Rugged EZ-Pro 2, Model No. 6091 Ambulance Cots.
CODE: All cots manufactured in the period August 14,
1999 to February 15, 2000. The first
four numbers of the serial number are 9908 through 9912, and 0001 and 0002.
MANUFACTURER: Stryker Medical, Kalamazoo, MI.
DISTRIBUTION: United States and Canada, Naval Medical
Clinic Portsmouth, NH, and Elmendorf AFB, AK.
QUANTITY: 172.
REASON: The device lock pin may not properly engage and
therefore the cot may drop to the next lower level while transporting patients.
PRODUCT: Clearview Easy hCG Pregnancy Test.
CODE: Lot Nos. CE0029A, CE0031/1A, CE0033A.
MANUFACTURER: Carter Wallace Inc., Cranbury, NJ.
DISTRIBUTION: Nationwide.
QUANTITY: 805 kits.
REASON: Contaminant in a batch of pouching foil, which may
affect the performance of this product.
PRODUCT: Whisperflow 2-60 CPAP Generator (with Criterion 60 Pressure/Oxygen
Monitor).
CODE: Serial numbers: 0526000711-01 through
0526000711-09; 0526000809-01 through 0526000809-12; 0526000814-01 through
0526000814-12
MANUFACTURER: Caradyne, Ltd., Galway, Ireland.
RECALLED BY: Engineered Medical Systems, Inc.,
Indianapolis, IN
DISTRIBUTION: Nationwide.
QUANTITY: 29
REASON: The observed measured oxygen reading might be
higher than that delivered to a patient.
PRODUCT: Immulite 2000 Automated Immunoassay Analyzer
Software Versions 1.6 and 1.61.
CODE: None.
MANUFACTURER: DPC Cirrus, Inc.,
Randolph, NJ
DISTRIBUTION: Nationwide. There are 8
Government accounts. The product was
shipped internationally to Argentina, Australia, Austria, Brazil, Canada,
Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Finland,
France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Mexico,
Netherlands, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South
Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK,
Venezuela.
QUANTITY: 962.
REASON: Software code is incorrect
for manual dilutions in the Batch Tests by Rack, which could cause incorrect
calculation of results.
PRODUCT: LiquiChem Liquid Reagent LD), Catalog No. 139-121
(USA), S1203 (International).
CODE: Lot No. 030004.
MANUFACTURER: Medical Analysis Systems,
Inc., Camarillo, CA.
DISTRIBUTION: PA and MA, Internationally
to Spain, England and Belgium.
QUANTITY: 50 kits.
REASON: Stability failure may not
flag a lower LD-P result indicating a potential problem for the patient.
PRODUCT: Lyphochek Anemia Control, Catalog Item 500.
CODE: Lot No. 43060.
MANUFACTURER: Bio-Rad Laboratories,
Inc., Irvine, CA.
DISTRIBUTION: Nationwide, and Australia,
Canada, France, Germany, Hong Kong, Italy, New Zealand, Sweden. Also U.S. Naval
Medical Center Portsmouth VA and VA Medical Center Albuquerque NM.
QUANTITY: 8,580 Vials distributed (6
per box for 1,430 boxes).
REASON: Defective control may
cause a slight increase in total variation (%CV and SD).
WEEK
ENDING FEBRUARY 16
PRODUCT: Electromyography (EMG)
Monitor, Nerve Locator/Stimulator, Model No. 302L A3000, Recall #Z-149-1; Model
No. 302P A3000
CODE:
9910-1000 9909-1001 9910-1002 9910-1005
9910-1006 9910-1007 9911-1008 9911-1009
9911-1011 9912-1012 9912-1013 0001-1014
0003-1015 FJ960184 120 132
134 137 142 144
166
MANUFACTURER: Neurosoft, Inc., El Paso,
TX.
DISTRIBUTION: Missouri, New York, California,
South Carolina, Texas, Ohio, Maryland, Minnesota, North Carolina, Canada,
Egypt, and the United Kingdom.
QUANTITY: 21
REASON: The device violates the
safety standard 601-1 identified in the pre-market approval.
PRODUCT: Electromyography (EMG)
Monitor, Nerve Locator/Stimulator Patient Interface for Model Nos. NIM2 and
NIM2XL.
CODE: 82-20201.
MANUFACTURER: Medtronic Xomed, Inc.,
Jacksonville, FL.
DISTRIBUTION: Nationwide and Hong Kong,
Turkey, Singapore, Switzerland, Israel, Sweden, Ireland, Taiwan-Republic of
China, Australia, France, Germany, Ontario-Canada, England and Osaka, Japan.
QUANTITY: 271.
REASON: The device may fail to
indicate the existence of a nerve and result in permanent nerve damage from
surgery, which would have a serious impact on the patient. The device defect presents a moderate risk
of severe adverse health consequences.
PRODUCT: Ohmeda Medical Two Mode
Continuous Vacuum Regulators:
Model 67xx1225-9xx - 2 Mode
Standard Clockwise Domestic;
Model 67xx1227-9xx - 2 Mode
Low Clockwise Domestic;
Model 67xx-1330-9xx - 2 Mode
High Clockwise Domestic;
Model 67xx-1230-9xx - 2 Mode
High Counter-clockwise
International; Model
67xx-1233-9xx - 2 Mode Low Counter-clockwise International.
CODE: Serial Nos. GFHD
004234-GFHD 053409.
MANUFACTURER: Aeros Instruments, Inc.,
Gurnee, IL.
DISTRIBUTION: 52 hospitals nationwide,
and 18 distributors in Saudi Arabia, Thailand, Kuwait, Canada, Germany, United
Kingdom, Australia, Spain, Italy, Honduras, Hong Kong, Belgium, Japan,
Malaysia, Ireland and Mexico.
QUANTITY: 818 units.
REASON: Continuous vacuum
regulator is mislabeled.
PRODUCT: TheraSeed Palladium 103
(Pd-103) Seeds.
CODE: Lots RP06N041A and
RM02N008Q.
MANUFACTURER: Theragenics Corporation,
Norcross, GA.
DISTRIBUTION: CO, CT, DE, FL, IL, IN,
MA, OH, TN, WA, WV, WI.
QUANTITY: 12.
REASON: Substandard spacers may
lead to difficulty during preparation and delivery of radiation therapy to the
patient.
PRODUCT:
Neoprene Knee Support with Ova Pad;
Perforated Knee Splint;
3"Elastic Ankle Wrap;
Universal Pelvic Traction Belt;
Universal Abdominal Binder, 9";
Universal Rib Belt;
6" Rib Belt;
Clavicle Strap II;
Clavicle Strap - Self Adjusting;
Tennis Elbow Strap;
Universal Ambidextrous Wristlet;
CODE: All codes for products
manufactured from 9/30/98 and 12/4/00
MANUFACTURER: DeRoyal Industries, Inc.,
Powell, TN.
DISTRIBUTION: Nationwide. Austria, Ireland, United Kingdom, Portugal, Costa
Rica, Sweden, El Salvador, Netherlands, Honduras, Saudi Arabia, Chile, Nairobe,
Switzerland, Japan and New Zealand. 17
Canadian firms and 74 US government/military accounts.
QUANTITY: 402,742.
REASON: Undeclared natural rubber
in the products.
PRODUCT: High Temperature Power Handle. Catalog No. HIT1.
CODE: All codes distributed
3/1/2000 to 7/1/2000.
MANUFACTURER: Aaron Medical Industries,
St. Peterburg, FL.
DISTRIBUTION: Nationwide, and France,
Finland, Canada, and Denmark.
QUANTITY: 125.
REASON: The descriptive labeling
imprinted on the body of the device identifies it incorrectly as a "low
temperature Power Handle." The
labeling of the device on the outer box correctly identifies the device as a
"High Temperature Power Handle."
PRODUCT: Cellpack-GL, Catalog No. PGL-300A.
CODE: PGL-300A.
MANUFACTURER: Sysmex Reagents America,
Inc., Los Alamitos, CA
DISTRIBUTION: Nationwide.
QUANTITY: 918 - 20 Liter containers.
REASON: Reagent design deficiency
provides too many false positive results.
PRODUCT: Tenure Dental Adhesive (DML-32).
CODE: Lot No. 461156;
MANUFACTURER: Den-Mat Corp., Santa
Maria, CA.
DISTRIBUTION: Canada.
QUANTITY: 17 units were recalled and
destroyed at the distributor.
REASON: Dental adhesive lot failed
the bond strength test prior to the expiration date of the product.
PRODUCT: Virtuoso Flowable Light Cure Composite with
Fluoride.
CODE: Lot No. 407001D, Part No.
030381827.
MANUFACTURER: Den-Mat Corp., Santa
Maria, CA
DISTRIBUTION: Nationwide.
QUANTITY: 565 syringes.
REASON: Lot failed the bond
strength test prior to the expiration date of the product.
WEEK
ENDING FEBRUARY 23
PRODUCT: Vitros Immunodiagnostic Products
AFP Reagent;
Catalog
No. 680 0784 AFP Reagent;
Catalog
No. 680 0038 CA 125 II Reagent Pack;
Catalog
No. 680 0039 CA 15-3;
Catalog
No. 189 6836 CK-MB Reagent Pack;
Catalog
No. 107 4053 Cortisol Reagent Pack;
Catalog
No. 835 6636 Ferritin Reagent Pack;
Catalog
No. 138 7000 Free T4 Reagent Pack;
Catalog
No. 193 1922 FSH Reagent Pack;
Catalog
No. 135 0198 LH Reagent Pack;
Catalog
No. 680 0030 NTx Reagent Pack;
Catalog
No. 184 9743 Prolactin Reagent Pack;
Catalog
No. 680 0269 Total B-hCG Reagent Pack.
CODE:
(1)
AFP, All lots below 5070;
(2)
CA 125 II, all lots below 120;
(3)
CA 15-3, all lots below 80;
(4)
CK-MB, all lots 101;
(5)
Cortisol, all lots below 81;
(6)
Ferritin, all lots below 112;
(7)
Free T4, all lots below 222;
(8)
FHS, all lots below 130;
(9)
LH, all lots below 101;
(10)
NTx, all lots below 100;
(11)
Prolactin, all lots below 102;
(12)
Total B-hCG, all lots below 140.
MANUFACTURER: Ortho-Clinical Diagnostics, Inc.,
Rochester, NY.
DISTRIBUTION: Nationwide to 157 clinic and hospital
laboratories, 26 Federal Government accounts (Contract V797P-6565A), and to 18
OCD/J&J Affiliates worldwide.
QUANTITY: 16,354 kits.
REASON: Defective microtiter wells in the various reagent
packs. Some wells were not coated with
the binding agent (Streptavidin).
PRODUCT: Cryovalve Allograft; a) Model No. AV00, Serial No. 3874532; b) Model
No. PV10, Serial No. 3874524.
CODE: a) Model No. AV00, Serial No. 3874532; b) Model
No. PV10, Serial No. 3874524;
MANUFACTURER: Cryolife, Inc., Kennesaw, GA.
DISTRIBUTION: Pasadena, CA. And Omaha, NE.
QUANTITY: 2 valves.
REASON: Donor did not meet current guidelines regarding
serodilution of plasma because of the amount of transfused/infused fluids
administered.
PRODUCT: Cryovalve Allograft; a) Model No. AV00, Serial No. 3958221; b) Model
No. PV00, Serial No. 3958248.
CODE: a) Model No. AV00, Serial No. 3958221; b) Model
No. PV00, Serial No. 3958248.
MANUFACTURER: Cryolife, Inc., Kennesaw, GA.
DISTRIBUTION: Milwaukee, WI. And Denver, CO.
QUANTITY: 2 valves.
REASON: Donor did not meet current guidelines regarding
serodilution of plasma because of the amount of transfused/infused fluids
administered.
PRODUCT: Cryovalve Allograft, Model No. PV05, Serial No. 3945944.
CODE: Model No. PV05, Serial No. 3945944.
MANUFACTURER: Cryolife, Inc., Kennesaw, GA.
DISTRIBUTION: Milwaukee, WI.
QUANTITY: 1 valve.
REASON: Donor did not meet current guidelines regarding
serodilution of plasma because of the amount of transfused/infused fluids
administered.
PRODUCT: Cryovalve Allograft, Model No. AV05, Serial No. 3945936.
CODE: Model No. AV05, Serial No. 3945936.
MANUFACTURER: Cryolife, Inc., Kennesaw, GA.
DISTRIBUTION: Cleveland, OH.
QUANTITY: 1 valve.
REASON: Donor did not meet current guidelines regarding
serodilution of plasma because of the amount of transfused/infused fluids
administered.
PRODUCT: Cryovalve Allograft, Model No. PV00, Serial No. 3946096.
CODE: Model No. PV00, Serial No. 3946096.
MANUFACTURER: Cryolife, Inc., Kennesaw, GA.
DISTRIBUTION: Tampa, FL.
QUANTITY: 1 valve.
REASON: Donor did not meet current guidelines regarding
serodilution of plasma because of the amount of transfused/infused fluids administered.
PRODUCT: Florestore Flowable Composite with Fluoride Light Cure.
CODE: Lot No. 407001C, Part No. 030381827.
MANUFACTURER: Den-Mat Corp., Santa Maria, CA.
DISTRIBUTION: Canada.
QUANTITY: 7
REASON: Lot failed the bond strength test prior to the
expiration date of the product.