OCTOBER
2001
WEEK ENDING OCTOBER 13
PRODUCT AND CODE: Patient Restraints, with
locks.
Codes:
Cat.
No. Name
1070 Keylock
Buckle
1334 Posey
Keylock Belt
1337 Swedish
Belt
2320
Series Connecting Straps
2350
Series Connecting Straps
2792 Locking
TAT Cuffs
2793 Locking
TAT Cuffs
2794 Wrist,
Bed Set
2795 Ankle,
Bed Set
2798 Locking
TAT Cuffs
2799 Locking
TAT Cuffs
2800 TAT
Ambulatory Belt
2801 TAT
Hobble
REASON: Locks break open at 50 pounds pressure specification
is 100 pounds.
MANUFACTURER/RECALLING FIRM: J. T. Posey Co. Arcada, CA
DISTRIBUTION: Nationwide
QUANTITY: 20,031
PRODUCT AND CODE: Medtronic Single Chamber
Temporary Pacemaker, Model 5348, Codes:Serial Numbers PEP016687P - PEP016696P,
PEP016698P - PEP016744P, PEP016746P - PEP016763P, PEP016765P - PEP016780P,
PEP016782P - PEP016797P, PEP016799P - PEP016809P, PEP016831P, PEP016922P,
PEP016952P, PEP016953P, and PEP016955P.
Use
before date of December 31, 2039 according to Medtronic's C/R report.
REASON: Possibility of device shutdown if the
non-conforming component fails. The device would not complete the self-test
routine prior to the shutdown. Another possible condition is that the battery
life may not last the intended 7 days at nominal settings.
MANUFACTURER/RECALLING FIRM: MedTronic, Inc.
Minneapolis, MN.
DISTRIBUTION: Nationwide and Canada, Netherlands and
Japan
QUANTITY: 42 pacemakers
PRODUCT AND CODE: Split Tissue Protection
Sleeve
Codes:
Product Number 393.745 Lot number 4041562 and Product Number 393-746 Lot number
4044728.
REASON: Mislabeled protection sleeves
MANUFACTURER: Synthes (USA) West Chester, PA
RECALLED BY: Synthes (USA) Paoli, PA
DISTRIBUTION: Nationwide
QUANTITY: 24 units
PRODUCT AND CODE: Save-A-Tooth Emergency
Tooth Preserving System. The product is
shipped in cases of 24 units. A unit is
a complete preserving system. The unit is a plastic jar filled with preserving
solution.
Codes:
catalog number Z-12488-1, part number 32-393, lot number 512844
REASON: Product leaking, compromising sterility.
MANUFACTURER: Polysciences, Inc. Warrington, PA
RECALLED BY: Save-A-Tooth, Inc. Pottstown, PA
DISTRIBUTION: AZ
QUANTITY: 417 cases
PRODUCT AND CODE: Examination gloves contained
in the following Products:
Product
name
1)
Central Line DRSG Valve
2)
Dry Prep Tray
3)
Peripheral Vascular Tray
4)
Sterile O.R. Prep Tray
5)
LTC/Laparoscopy Tracepak
6)
Dr. Calhoun Lap Chole
7)
Exit Site Care Kit
8)
Pgy-Bk Peritonitis Kit
9)
Patient Prep Tray
10)
Diag. Gyn. Lapar Tracepak
11)
Dr. Danielson ACF Tracepak
12)
Cath Lab Pacemaker
13)
Dr. Pridjian Heart Tracepak
14)
Exploratory Lap Tracepak
15)
Prostatectomy Tracepak
Codes:
Product code Lot number
1) 50-13363 501105
2) 50-10751 500067
3) 50-3052 485681
4) 50-750 494735
5) 90-0185 509809
6) 90-0224 505813
7) 50-9246 492900, 503238
8) 50-9248 503239
9) 50-002 500644
10) 90-1342 502793, 511059
11)
90-1031 507203
12)
90-1742 510730
13)
90-1972 505551, 505473
14)
90-0731 508799
15)
90-2229 505715
REASON: Examination gloves in surgical kits fail leak test
due to defects and holes
MANUFACTURER: DeRoyal Orthopedic Fabrication,
Maynardville, TN
RECALLED BY: The DeRoyal Industries, Inc Powell, TN
DISTRIBUTION: LA, PA, TN, NY, OK, CA, MN, MS and NC
QUANTITY: 358
PRODUCT AND CODE: Allograft Heart Valve,
Codes:
Serial
No. - 6226337 - Model No. AV05
Serial
No. - 6226345 - Model No. PV05
Serial
No. - 6289924 - Model No. AV00
Serial
No. - 6289932 - Model No. PV00
REASON: Donor does not meet current guidelines for
serodilution of plasma
MANUFACTURER/RECALLING FIRM: CryoLife, Inc. Kennesaw,
GA
DISTRIBUTION: AZ, MT, MO and GA.
QUANTITY: 4 valves
PRODUCT AND CODE: MacConkey Agar w/
Sorbitol, Product No. 01-556, packaged 10 plates per sleeve, Codes: MacConkey
Agar w/ Sorbital, Catalog No. 01-556, Lot No. 057184, Exp. Date 02-12-01
REASON: Product is mislabeled as MacConkey Agar w/
Sorbital.
MANUFACTURER/RECALLING FIRM: Remel Inc. Lenexa, KS
DISTRIBUTION: Nationwide
QUANTITY: 2,730 plates
PRODUCT AND CODE: 18" Flat Panel Color
LCD Monitor with touch screen, Codes: Part Number: 0160-00-0059, Serial Number:
01-9694, 01-9698, 01-9682, 01-9683, 01-9688, 01-9696, 01-9700, 01-9703,
01-9699. Distributed in France:
01-9685, 01-9686, 01-9690, 01-9695, 01-9704, 01-9901
REASON: In attempting to incline the monitor, the montior
may tip over
MANUFACTURER/RECALLING FIRM: DataScope Corp.,Mahwah, NJ
DISTRIBUTION: Nationwide and International
QUANTITY: 15
PRODUCT AND CODE: Allograft Heart Valve,
Model Numbers AV00 and PV00, Codes: Model Number AV00 - Serial Number 3861457
Model
Number PV00 - Serial Number 3861465
REASON: Donor does not meet current guidelines regarding
serodilution of plasma
MANUFACTURER/RECALLING FIRM: Cryolife, Inc. Kennesaw,
GA
DISTRIBUTION: OH
QUANTITY: 2 valves
PRODUCT AND CODE: Allograft Heart Valve,
Model Numbers AV00 and PV00, Codes:Model AV00 - Serial Number 3789357
Model
PV00 - Serial Number 3789349
REASON: Donor does not meet current guidelines regarding
serodilution of plasma
MANUFACTURER/RECALLING FIRM: Cryolife, Inc. Kennesaw,
GA
DISTRIBUTION: TN and WA
QUANTITY: 2 valves
PRODUCT AND CODE: Allograft Heart Valve, Model
Number AV00 and PV00, Codes: Model No. AV00 - Serial Number 3896536
Model
No. PV00 - Serial Number 3896528
REASON: Donor does not meet current guidelines regarding
serodilution of plasma
MANUFACTURER/RECALLING FIRM: Cryolife, Inc. Kennesaw,
GA
DISTRIBUTION: IN
QUANTITY: 2 valves
PRODUCT AND CODE: Allograft Heart Valve,
Model Number PV00 Codes: Model No. PV00 - Serial Number 6335756
REASON: Donor does not meet current guidelines regarding
serodilution of plasma
MANUFACTURER/RECALLING FIRM: Cryolife, Inc. Kennesaw,
GA
DISTRIBUTION: New York, NY
QUANTITY: 1 valve
PRODUCT AND CODE: Monticelli Spinelli Single
Action Wire Tensioner Wire Tensioner Orthopedic Manual Surgical Instrument
Codes:
Product: Monticelli-Spinelli Single
Action Wire Tensioner Catalog No:
5119-0-850 Lot: All
manufacturing lot codes
REASON: The internal mechanism may experience wear that
eventually hinders its function
MANUFACTURER: Stryker Trauma Geneva, Switzerland,
RECALLED BY: Howmedica Osteonics Corp., Rutherford, NJ
DISTRIBUTION: Nationwide and Australia
QUANTITY: 128
PRODUCT AND CODE: Baxter Interlink System
Micro-Infusion Manifold with 4-Way Stopcock and Extension Set, product code
2N3411; Baxter Healthcare Corporation, Deerfield, IL, Codes: Product code
2N3411, lot U557207R
REASON: Pinholes in packaging compromise the sterility of
the product
MANUFACTURER: Baxter Healthcare Corp. of Puerto Rico
Aibonito, PR.
RECALLED BY: Baxter Healthcare Corp., Round Lake, IL
DISTRIBUTION: IN and Japan
QUANTITY: 2150 units
PRODUCT AND CODE: Codes:
A)
Bivona Flextend Plus pediatric cuffless tracheostomy tube. All catalog numbers beginning with
60PFP. All lots.
B)
Bivona Flextend Standard pediatric cuffless tracheostomy tube. All catalog numbers beginning with
60PFS. All lots.
C)
Bivona obturators labeled for use with Bivona Flextend Plus or Flextend
Standard tracheostomy tubes. All catalog numbers
beginning
with the letters OBT and ending with the numbers –009-3. All lots.
REASON: Obdurator tip may not be bonded to the shaft
MANUFACTURER/RECALLING FIRM: Bivona Medical
Technologies, Inc. Gary, IN.
DISTRIBUTION: Nationwide and Belgium, England, France and
Germany
QUANTITY: 548
PRODUCT AND CODE: Steris Quick Connect,
Model C1665, is designed to process the Olympus 20D Series and BF-XT20
Bronchoscopes in STERIS SYSTEM I Sterile Processing System, with C1160
Universal Processing Tray.
Codes:
Lot Number: CA22900, Catalogue Number:
#QC 1665.
REASON: The tubing in the kits are labeled with an
incorrect endoscope model number.
MANUFACTURER/RECALLING FIRM: Steris Corp. Mentor, OH
DISTRIBUTION: GA
QUANTITY: 2 units
PRODUCT AND CODE: BD Vacutainer Plus Plasma
Separator Tube (PST) 4.5.ml 13 x 100,
Codes:
Catalog Number: 367962, Lot Number:
1008353
REASON: Some tubes did not have required amount of Lithium
Heparin
MANUFACTURER: Becton Dickinson & Co., Broken Bow, NE
RECALLED BY: Becton Dickinson & Co. Franklin Lakes,
NJ.
DISTRIBUTION: Nationwide
QUANTITY: 1,017,000 tubes
PRODUCT AND CODE: Software versions AE through
AL (except AI) for the Bayer Advia Centaur Automated Chemiluminescence
Immunoassay System. The affected
software was distributed as a component of the Advia Centaur Automated
Chemiluminescence Immunoassay system.
Codes: Software versions AE through AL, except version AI. Catalog
Number: 120535
REASON: Software defect.
MANUFACTURER/RECALLING FIRM: Bayer Corporation
Tarrytown, NY
DISTRIBUTION: Nationwide and France, Canada, Belgium,
Australia, Sweden and Germany.
QUANTITY: 57 units contain the affected software
WEEK ENDING OCTOBER 20
PRODUCT AND CODE: Integra Neurosciences True
Tech REF NL960-V Ventricular Tunneling Pressure Monitoring Kit
Ventrix®
True Tech
Codes: Lot numbers:
a)
VTT0024 Carries an Expiration Date of August 2001
b)
VTT0025 Carries an Expiration Date of August 2001
c)
VTT0026 Carries an Expiration Date of October 2001
REASON: The "lock/unlock" label was reversed on
the catheter connector.
MANUFACTURER/RECALLING FIRM: Integra Neurocare LLC, San
Diego, CA
DISTRIBUTION: Nationwide
QUANTITY: a) 24 units; b) 48 units; and c) 36 units.
PRODUCT AND CODE: Western OPC-830 Portable
Oxygen Conserving Regulator. The
OPC-830 is a regulator and conserving device combined within one unit. The user can switch between the Continuous
Mode (delivers a constant flow, regardless of breathing patterns) and Conserve
Mode (delivers flow only during inhalation) without disconnecting the unit.
Codes: All Serial Numbers.
REASON: Defective demand valve does not function as intended
in the 'Conservative Mode'.
MANUFACTURER/RECALLING FIRM: Western Medica Westlake,
OH.
DISTRIBUTION: Nationwide
QUANTITY: 1,846 units.
PRODUCT AND CODE: Babytherm 8004/8010 with
Phototherapy Option. The device is an infant warming system.
Codes:
Catalog Numbers FR00104, FR00105, FR00114, FR00120, FR00098, 2M30404.
REASON: Breakage
MANUFACTURER: Drager Medizintechnik GmbH Lubeck, Germany,
RECALLED BY: North American Drager,Telford, PA
DISTRIBUTION: Nationwide
QUANTITY: 140 units
PRODUCT AND CODE: MediVators brand Rapicide
High-Level Disinfectant and Sterilant.
Active ingredient:
Glutaldehyde.
CODE:
Lots L020711, L021211 and L021411.
REASON: Bottles may leak.
MANUFACTURER/RECALLING FIRM: Ecolab Inc. Huntington, IN
DISTRIBUTION: MN
QUANTITY: 2,956 cases of 4 units each
PRODUCT AND CODE: COBAS Integra 400
laboratory clinical chemistry analyzer, Model 400, Catalog number 1045199. All
serial numbers of analyzers lower than 38-2606. Serial numbers of 38-2606 or higher have already been updated with
software revision upgrade 4.
REASON: If the operator fails to position the diluent on
the instrument, the instrument may not detect that the reagent is missing an
aspirate air instead of diluent.
MANUFACTURER: Tegimenta, AB Switzerland,
RECALLED BY: Roche Diagnostics Corp. Indianapolis, IN
DISTRIBUTION: Nationwide
QUANTITY: 161 units
PRODUCT AND CODE: Heartport brand StillSite
II Stabilizer, Straight Arm, A beating Heart Stabilization System Codes: 505021F; 515011B; 515011A Catalog Numbers:
PO-S2S, P0-S2C
REASON: Sterility may be compromised
MANUFACTURER: MedSource - Newton Newton, Ma
RECALLED BY: Heartport, Inc. Redwood City, CA
DISTRIBUTION: Nationwide
QUANTITY: 466 devices
PRODUCT AND CODE: Dual Stage Venous Return
Cannulae, labeled in part: "PRODUCT CODE: DNF-3651S DUAL STAGE VENOUS
RETURN CANNULA, NON-WIRE REINFORCED, 36/51 FR. BULLET TIP STERILE EO CHASE
Medical, Inc. Richardson, TX
75081", packaged individually, 10 units per shipping box. DNF-3651SLot Numbers: C008135, C008159, C009180, C010120, C010206
REASON: Tip may separate in use
MANUFACTURER/RECALLING FIRM: Chase Medical, Inc.
Athens, TX
DISTRIBUTION: Scotland and Portugal
QUANTITY: 280 units
WEEK ENDING OCTOBER 27
PRODUCT AND CODE:
Codes:
A) Stryker Zoom Patient Transport
Frame. Model 2040; Serial numbers 0012036662, 0012036663 and 010215001 through
0107037043.
B) Stryker Epic II Critical Care bed with
Zoom. Model 2030; Serial numbers 010215606
through 0106036627.
C)
Stryker Secure II Med/Surg bed with Zoom.
Model 3002; Serial numbers 0101035906 through 010515421.
REASON: Inverter/charger board may catch fire when
unplugged from power source.
MANUFACTURER/RECALLING FIRM: Stryker Corp. Kalamazoo,
MI
DISTRIBUTION: Nationwide, Brazil and Korea
QUANTITY: 271 beds
PRODUCT AND CODE: IMMULITE Turbo Troponin I
Kit. An in-vitro diagnostic kit for the quuantitative measurement of Troponin I
in serum or plasma. Models affected are 100 test kit (LSKTI1 lot 118) and 500
test kit (LSKTI5 lot 118).
REASON: Component mix-up in diagnostic kit
MANUFACTURER/RECALLING FIRM: Diagnostic Products Corp.,
Los Angeles, CA
DISTRIBUTION:
Nationwide and Worldwide
QUANTITY: 318 100 test kits; 6 500 test kits
PRODUCT AND CODE: Cryocyte Freezing
Containers, 250 ml with Label Pocket. Labeled in part, "Immunotherapy Code
XXXXXX Cryocyte Freezing Container with Label Pocket 250 ml Capacity*** Baxter
Healthcare Corporation, Deerfield IL 60015" Codes:
Codes:
4R9953, , 4R9959, R4R9951,R4R9955 Lots: H98G14462R, H98G23463R
REASON: Cracking of fill tubing.
MANUFACTURER/RECALLING FIRM: Nexell Therapeutics, Inc.,
Irvine, CA
DISTRIBUTION: Nationwide and Canada.
QUANTITY: 103 cases
PRODUCT AND CODE: Behring Coagulation System
(BCS) Coagulation Analyzer. Codes: Software Version 2.2 Code OVIO03
REASON: Falsely shortened APTT value.
MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH,
Marburg, Germany
RECALLED BY: Dade Behring, Inc., Newark, DE
DISTRIBUTION: Nationwide
QUANTITY: 167
PRODUCT AND CODE: American Medical System
Cavernotome C&R Disposable Dilators; set includes 4 sizes of dilators.
Codes:
Lot Numbers: R11,584/5/6/7 Part Number: 72403293
REASON: Sterile disposable dilators punctured sterile packaging
in transit.
MANUFACTURER/RECALLING FIRM: Uroan XXI Electromedicina
Palma De Mallorca, SP
RECALLED BY: American Medical Systems, Inc., Minnetonka,
MN
DISTRIBUTION: Nationwide
QUANTITY: 107 Units
PRODUCT AND CODE: Chamberlite Emergency
Portable Hyperbaric ChamberLabeled: Operation Pressure 15 PSI
Codes:
Serial numbers: 10, 14, 51, 52, 170, 205, 311, 312, 313, 314, 504, 538, 539,
657, 752, 753, 755, 756, 817, 818, and 820
REASON: Firm is distributing device at a higher psi level
than it is approved for.
MANUFACTURER/RECALLING FIRM: Hyperbaric Technologies,
Inc. Amsterdam, NY
DISTRIBUTION: Nationwide
QUANTITY: 21 units
PRODUCT AND CODE: Premier brand Chagas IgG
EIA test kits. Codes: Lot # TCE100.012, Exp Date: 4/5/02
REASON: False positive test results.
MANUFACTURER/RECALLING FIRM: Meridian Bioscience, Inc.,
Cincinnati, OH
RECALLED BY: Meridian Diagnostics, Inc., Cincinnati, OH
DISTRIBUTION: IA, MN, TX and Brazil and Panama Republic.
QUANTITY: 859 kits
PRODUCT AND CODE: Nipro Safe Touch Safety
Fistula Needle Codes: All model numbers and lot numbers are included in this
recall.
model(
Reorder or Catalog numbers) and lot numbers below:
REORDER
NUMBER LOT
NUMBERS
FS
152530BC 01B22,
01B26, 01C01, 01C09, 01C16, 1C21, 01C17, 01C18, 01C22, 01C24, 01D04, 01D05,
01C30
FS
152530BCR 01C28,
01C30, 01C29, 01D01
FS
162530BC 01B25, 01B26,
01C18, 01C12, 01C14, 01C15, 01C16, 01C17
FS
142530BC 01C27,
01C26, 01C28
FS
172530BC 01C24,
01C23, 01C26
REASON: Needle may separate from the hub of the fistula
needle
MANUFACTURER/RECALLING FIRM: Nissho Nipro Corp., LTD.,
Ayuthaya
RECALLED BY: Nipro Medical Corporation Miami, FL
DISTRIBUTION: VA, IL, CO, TN and MA.
QUANTITY: 696,500
PRODUCT AND CODE: Gamow Bag, a portable
hyperbaric chamber, Codes: All Gamow Bags with S/N's between "31" and
"1062"
REASON: Unsubstantiated claims for HACE and HAPE
MANUFACTURER/RECALLING FIRM: Hyperbaric Technologies,
Inc. Amsterdam, NY
DISTRIBUTION: CO and Japan, India and NYS
QUANTITY: 86
PRODUCT AND CODE: Pediatric Pallet, part
number 5239715; an accessory used with the E.CAM Emission Imaging Computed
Tomography Systems to adapt the unit for pediatric use for all common nuclear medicine
procedures. Codes: All Pediatric Pallets sold as accessories to the following
E.CAM Systems:
Model
4380221 - E.CAM Gantry Dual Head Variable, serial numbers 0005 through 1215
Model
5242826 - E.CAM Gantry Dual Head Variable, serial numbers 1001 through 3141 and
4001 through 4111
Model
5977066 - E.CAM Gantry Dual Head Variable, serial numbers 4100 through 4178
Model
4380213 - E.CAM Gantry Single Head, serial numbers 0001 through 4016
Model
5977074 - E.CAM Gantry Single Head, serial numbers 4001 through 4031
REASON: Pediatric Pallet plunger end pin may break
MANUFACTURER/RECALLING FIRM: Siemens Medical Systems,
Inc., Hoffman Estates, IL
DISTRIBUTION: Nationwide.
QUANTITY: 28 pallets
PRODUCT AND CODE: AccuSync 7 ECG Gating
Device/Monitor used as an accessory to the E.CAM family of Emission Imaging
Computed Tomography Systems to monitor the patients' cardiac output and act as
a trigger during gated cardiac acquisitions; Siemens Medical Systems Inc.,
Hoffman Estates, IL; two models of monitor were affected by the recall:
a)
ECG Monitor without Chart Recorder, part 5220327
b)
ECG Monitor with Chart Recorder, part 5220335
Codes:
Accusync 7 ECG Monitors, Models 7000-3 and 7000-3P, part numbers 5220327 and
5220335 respectively, shipped as accessories with the following cameras: Model
4380221 - E.CAM Gantry Dual Head Fixed, serial numbers 9, 13, 1005 through 1215
Model
5242826 - E.CAM Gantry Dual Head Variable, serial numbers 1001 through 1131 and
2001 through 2082
Model
4380213 - E.CAM Gantry Single Head Fixed, serial numbers 1, 2, 1002 through
1022 and 2002 through 2022
Model
3562357 - Multispect 2 HD3 Gantry, serial numbers 1017, 1028, 1039, 1044, 1046,
1047, 1048
Model
3562332 - Diacam HD3 Gantry Integrated, serial numbers 1001 through 1106
REASON: Monitor generates ECG patterns & traces when
not connected to patient
MANUFACTURER/RECALLING FIRM: AccuSync Medical Research
Corp. Milford, CT
RECALLED BY: Siemens Medical Systems, Inc., Hoffman
Estates, IL
DISTRIBUTION: Nationwide and Worldwide
QUANTITY: 432 monitors
PRODUCT AND CODE: Boston Scientific
Corporation’s Viper Small Vessel Peripheral (Balloon) Dilatation Catheters with
Bioslide Hydrophilic Coating,
Model Lot
Numbers
M001192060 4009868
M001192130 4006308
M001192150 4003520, 4009870
M001192020 4003569
M001192110 4003574
REASON: Some units have mid-shaft bond strengths below
specifications making it is possible that a distal segment of the catheter may
become detached.
MANUFACTURER/RECALLING FIRM: Boston Scientific SciMed,
Inc., Maple Grove, MN
DISTRIBUTION: FL, GA, IL, NY, WA and Germany
QUANTITY: 22 catheters
PRODUCT AND CODE: Airlife Manual
Resuscitation Bags, Latex Free; a disposable single patient use device used for
pulmonary resuscitation; the immediate container has the warning
"IMPORTANT Perform functional test on Resuscitator by squeezing the bag
and verifying proper valve action PRIOR TO PLACING IN SERVICE";
Manufactured for Allegiance Healthcare Corporation, IL
Codes:
Catalog # 2K8001, 2K8005 and 2K8017: all lots beginning with Y9, Y0, Y1A and
04440, 04401, 04634, and all lots between Y1B0000 through Y1B0257
Catalog
#2K8008 and 2K8010: Any lot number where the last six digits are prior to
001216, where the digits represent the year, the month and the day, i.e. 2000,
DEC 16 and prior Catalog #2K8000, 2K8004, 2K8018, 2K8019, 2K8020, 2K8021,
2K8032, 2K8033, 2K8034, 2K8035, 2K8036, 2K8037, 2K8038, 2K8039 and 2K8040: Any
lot number where the last six digits are prior to 010115, i.e. prior to 2001
JAN 15 Custom Sterile kit product numbers packaged with the above listed
resuscitation bags include:
Kits
containing adult resuscitation bags:
a)
BLK675361A, manufacture dates 03/03/1999, 03/24/1999, 04/12/1999, 05/25/1999
b)
BLKOC1026B, manufacture dates 03/02/2001, 03/20/2001
c)
PC12CG15A, manufacture date 11/05/1999
d)
PC12CG15B, manufacture dates 11/11/1999, 12/21/1999
e)
PC12CG15C, manufacture dates 12/21/1999, 01/19/2000, 01/31/2000, 02/08/2000,
02/22/2000, 03/24/2000, 04/13/2000, 04/18/2000, 04/20/2000
f)
PC12CG15D, manufacture dates 05/08/2000, 05/10/2000, 05/12/2000
g)
PC12CG15E, manufacture date 05/26/2000
h)
PC12CG15F, manufacture dates 06/15/2000, 06/20/2000, 06/30/2000, 07/19/2000,
07/25/2000, 08/09/2000, 08/17/2000, 08/23/2000, 08/31/2000,
09/09/2000,
10/02/2000, 10/20/2000, 10/24/2000, 10/31/2000, 11/20/2000, 11/29/2000,
12/02/2000, 12/26/2000, 01/23/2001, 02/02/2001, 02/16/2001, 03/14/2001
i)
PC12CGFFZ, manufacture dates 10/22/1999, 11/02/1999
j)
PC12VR15A, manufacture dates 12/10/1999, 01/11/2000, 01/31/2000, 03/24/2000,
04/20/2000
k)
PC12VR15B, manufacture dates 05/05/2000, 05/20/2000
l)
PC12VR15C, manufacture date 05/25/2000
m)
PC12VR15D, manufacture dates 06/20/2000, 07/03/2000, 08/02/2000, 08/25/2000, 09/26/2000,
09/28/2000, 11/03/2000, 11/19/2000, 11/29/2000,
12/28/2000,
01/23/2001, 02/02/2001, 02/21/2001, 03/09/2001, 05/14/2001
n)
PC12VRFFZ, manufacture date 10/04/1999
o)
PC21CGMMQ, manufacture dates 08/16/2000, 10/03/2000
p)
PC21CGMMR, manufacture date 11/09/2000
q)
PC21CGMMS, manufacture dates 11/17/2000, 11/20/2000
r)
PC21CGMMT, manufacture date 01/08/2001
s)
PC21CGMMU, manufacture dates 02/08/2001, 03/09/2001
t)
PC21HTMMF, manufacture date 07/14/2000
u) PC21HTMMG,
manufacture dates 07/17/2000, 08/28/2000, 10/04/2000
v)
PC21HTMMH, manufacture date 10/06/2000
w)
PC21HTMMI, manufacture dates 11/30/2000, 01/08/2001, 01/30/2001, 03/09/2001
x)
PC21HTMMJ, manufacture date 03/22/2001
y)
PC21HTMMK, manufacture date 04/25/2001
z)
PC21VRMMM, manufacture dates 09/01/2000, 10/11/2000, 11/17/2000, 12/13/2000
aa)
PC21VRMMN, manufacture dates 12/20/2000, 12/22/2000
bb)
PC23OHAKJ, manufacture dates 12/20/1999, 01/26/2000, 02/16/2000, 03/21/2000,
05/12/2000
cc)
PC23OTMUB, manufacture dates 01/11/2000, 01/20/2000, 02/22/2000, 03/13/2000,
04/25/2000, 05/17/2000, 06/07/2000, 07/18/2000, 08/09/2000, 08/22/2000,
10/04/2000, 11/21/2000, 11/27/2000, 11/29/2000, 12/08/2000, 01/05/2001,
12/22/1999R
dd)
PC43CGSPB, manufacture date 05/09/2000
ee)
PC73OHASJB, manufacture date 05/11/2001
ff)
PC73OHSJA, manufacture dates 04/03/2001, 04/16/2001
gg)
PC73OHSJB, manufacture dates 05/04/2001, 05/07/2001
hh)
PV12AAFFJ, manufacture dates 08/06/1999, 09/08/1999, 09/27/1999, 12/14/1999,
01/14/2000, 02/02/2000, 02/25/2000, 04/11/2000, 04/21/2000
ii)
PV12AAFFK, manufacture date 05/24/2000
jj)
PV12AAFFL, manufacture dates 06/07/2000,
07/27/2000, 11/20/2000, 01/17/2001, 02/23/2001
kk)
PV12AAFFM, manufacture date 05/09/2001
ll)
PV12CVUME, manufacture dates 10/22/1999, 10/28/1999, 11/10/1999, 11/15/1999
mm)
PV12CVUMF, manufacture dates 12/09/1999, 01/11/2000
nn)
PV12CVUMG, manufacture dates 02/01/2000, 02/24/2000, 02/25/2000, 03/08/2000
oo)
PV12CVUMH, manufacture dates 03/28/2000, 04/15/2000, 04/26/2000, 05/01/2000,
05/11/2000, 05/13/2000, 05/18/2000, 06/01/2000, 06/14/2000, 06/26/2000
pp)
PV12CVUMI, manufacture dates 07/11/2000, 08/04/2000, 08/25/2000, 09/26/2000,
10/09/2000, 10/12/2000, 10/20/2000, 11/07/2000, 12/18/2000, 12/23/2000,
01/12/2001, 02/13/2001, 02/22/2001, 03/19/2001, 04/23/2001, 05/23/2001,
05/31/2001
qq)
RE1239086A, manufacture date 06/08/2000
rr)
RES131431A, manufacture dates 12/17/1998, 12/17/1998, 12/17/1998
ss)
RES215902D, manufacture dates 09/14/2000, 12/09/2000
tt)
RES232917A, manufacture dates 12/08/1999, 03/08/2000, 04/29/2000
uu)
RES235488B, manufacture dates 04/06/1999, 04/09/1999, 06/03/1999, 08/19/1999,
10/27/1999, 12/01/1999, 12/27/1999, 02/17/2000, 05/03/2000, 09/20/2000,
12/26/2000, 01/11/2001, 03/13/2001, 05/14/2001
vv)
RES361278A, manufacture dates 11/12/1998, 11/25/1998, 12/11/1998, 03/09/1999,
04/20/1999, 06/02/1999, 07/19/1999, 08/19/1999, 10/01/1999, 10/27/1999,
11/15/1999, 12/09/1999
ww)
RES365784A, manufacture dates 03/01/1999, 03/26/1999, 04/26/1999, 05/12/1999, 06/10/1999,
08/06/1999, 08/19/1999, 09/02/1999, 10/28/1999, 12/08/1999, 07/12/2001
xx)
RES377177C, manufacture dates 11/24/1998, 01/06/1999, 01/06/1999, 07/12/1999,
08/12/1999, 09/15/1999, 10/21/1999, 12/10/1999, 01/25/2000, 01/28/2000,
03/29/2000
yy)
RES411065A, manufacture dates 12/01/1998, 12/01/1998, 01/05/1999, 01/05/1999,
01/05/1999, 01/11/1999, 01/11/1999, 01/11/1999, 02/16/1999, 02/16/1999,
02/16/1999, 03/26/1999, 03/26/1999, 03/26/1999, 05/01/1999, 05/13/1999,
05/13/1999
zz)
RES413580A, manufacture date 11/30/1998 aaa) RES459293A, manufacture date
03/02/2001 bbb) RES459293B, manufacture date 3/02/2001
ccc)
RES731619B, manufacture dates 06/20/2001, 07/12/2001
ddd)
RES90RESUB, manufacture dates 04/13/1999, 04/23/1999
eee)
RESOC1026A, manufacture dates 12/15/1998, 01/08/1999, 02/09/1999
fff)
RESOC1431B, manufacture dates 01/14/1999, 03/09/1999, 05/12/1999, 07/09/1999,
10/01/1999, 12/20/1999
ggg)
RESOC5849A, manufacture dates 11/16/1998, 11/16/1998, 12/15/1998, 12/15/1998,
01/11/1999, 01/11/1999, 02/23/1999,
02/23/1999,
04/01/1999, 04/01/1999, 05/14/1999, 05/14/1999, 06/24/1999, 06/24/1999,
09/13/1999, 09/13/1999
hhh)
RESOC-6120, manufacture dates 11/20/1998, 01/07/1999, 02/02/1999
iii)
RESOC6120C, manufacture dates 04/27/1999, 06/02/1999, 06/02/1999, 07/15/1999,
07/15/1999, 08/25/1999, 08/25/1999,
10/12/1999,
10/12/1999, 11/11/1999, 11/11/1999, 02/02/2000, 02/02/2000
jjj)
RESOC7180A, manufacture dates 04/07/1999, 05/12/1999, 06/18/1999
kkk)
RESOC7692A, manufacture dates12/09/1998, 12/09/1998
lll)
RPK218814A, manufacture dates 11/02/2000, 11/16/2000, 11/30/2000, 01/02/2001,
01/17/2001, 02/07/2001, 02/21/2001, 03/27/2001
mmm)
RPS411211B, manufacture dates 11/16/2000, 11/28/2000
nnn)
RPS670132B, manufacture date 09/12/2000
ooo)
SPK218814A, manufacture dates 07/13/2000, 08/07/2000
ppp)
SPK417242A, manufacture dates 06/21/2000, 06/30/2000 kits containing pediatric
resuscitation bag
a)
PRES461932, manufacture dates 11/10/1998, 11/30/1998, 03/04/1999, 03/09/1999
b)
RE1365784A, manufacture dates 03/31/2000, 03/31/2000, 03/28/2001, 03/28/2001
c)
RE1OC5445A, manufacture date 07/13/2001
d)
RE1VF0326A, manufacture dates 03/12/2001, 03/12/2001
e)
RES239086A, manufacture dates 02/11/2000, 03/10/2000, 05/25/2000, 06/08/2000,
11/03/2000
f)
RESOC7004A, manufacture date 03/12/2001
g)
SP1215902C, manufacture dates 06/14/2000, 08/02/2000, 09/19/2000, 10/31/2000,
11/13/2000, 01/15/2001, 03/07/2001, 06/30/2001
REASON: Resuscitation bags may not allow proper duck bill
valve action
MANUFACTURER/RECALLING FIRM: Engineered Medical
Systems, Inc. Indianapolis, IN
RECALLED BY: Allegiance Healthcare Corporation McGaw
Park, IL
DISTRIBUTION: Nationwide
QUANTITY: 2,076,594 units
PRODUCT AND CODE: Laser Doppler Flowmeter,
PF 5001 Main Unit; a Blood Flow Meter. Used for housing Laser Doppler Blood
Perfusion modules: PF 5010 Laser Doppler Module, or PF 5040 Transcutaneous
Oxygen Module. Codes: Serial Numbers: 1196 and 1199
REASON: A low output level from the laser light will
result in device failure during use
MANUFACTURER/RECALLING FIRM: Perimed AB Jarfalla -
Sweden
RECALLED BY: PeriMed, Inc., North Royalton, OH
DISTRIBUTION: AZ and IL
QUANTITY: 2
PRODUCT AND CODE: Constellation brand
Multiple Electrode Recording and Pacing Catheter. Codes: All lots affected.
REASON: Product may be contaminated with small fibers on
the distal tip of the catheter.
MANUFACTURER/RECALLING FIRM: Boston Scientific Corp.
San Jose, CA
DISTRIBUTION: Nationwide and worldwide
QUANTITY: 4,416 units
PRODUCT AND CODE: IsoMed Constant-Flow
Infusion System Clinical Reference Guide for Pain Therapy, Product Catalog
Number 182369-102/UC1999901594a EN NP3821 Codes: Lot number: None (clinical
guides do not have lot numbers)
REASON: Clinical guides given to physicians to aid their
management of patients with IsoMed pumps lack a warning statement.
MANUFACTURER/RECALLING FIRM: Medtronic, Inc.,
Neurological Division, Minneapolis, MN
DISTRIBUTION: Nationwide
QUANTITY: 102 Reference Guides
PRODUCT AND CODE: AxSYM Total T4 Reagent
AxSYM
Total T4 is a Fluorescence Polarization Immnunoassay (FPIA) for the
quantitative determination of thyroxine (T4) in human serum or plasma. This
includes both protein-bound and unbound forms of thyroxine. The AxSYMm Total T4
assay is used as an aid in the assessment of thyroid status. Codes: List
No.: 7A55-20 Lot No.: 70892Q100, 70892Q101 and 70892Q102 Exp. Date: 10/12/2001
REASON: Failure to calibrate the assay when using
these reagents lots
MANUFACTURER/RECALLING FIRM: Abbott Health Products,
Inc., Barceloneta, PR
DISTRIBUTION: Nationwide and Worldwide
QUANTITY: 11,259 kits
PRODUCT AND CODE: NORMOCARB (Sterile
Bicarbonate Renal Dialysis Concentrate).
Lots 1A530, 1A620, 1A940, 1B270, 1B280, 1C330, GA0951, GA1188, GA1190
and GA2889 Codes:
REASON: Contaminated with microorganism
MANUFACTURER/RECALLING FIRM: Dialysis Solutions, Inc.
Richmond Hills, Ontario, Canada
RECALLED BY: Novex Pharma Richmond Hills, Ontario,
Canada
DISTRIBUTION: AL, CA, MA, MS, NY, NC, PA
QUANTITY: Approx. 330 cases
PRODUCT AND CODE: Depuy brand PFC Sigma Knee
System fluted femoral stem, 18 mm x 175 mm. Catalog number 96-1713, Lot 099495.
Codes:
Depuy brand PFC Sigma Knee System fluted femoral stem, 18 mm x 175 mm. Catalog
number 96-1713, Lot 099495.
REASON: Mislabeled as to size
MANUFACTURER/RECALLING FIRM: Depuy Orthopaedics, Inc.,
Warsaw, IN
DISTRIBUTION: FL, LA, ME, MO, NV and England
QUANTITY: 20
PRODUCT AND CODE: Junction Box, a component
of Invacare Electric Beds, AC-Powered Adjustable Hospital.
Codes:
All affected junction boxes are identified with the date of manufacture from
8/1/1998 thru 10/31/2000.
REASON: A faulty junction box may overheat, and result in
electrical failure with potential fire hazard.
MANUFACTURER/RECALLING FIRM: Invacare Corp. Sanford, FL
RECALLED BY: Invacare Corp. Elypia, OH
DISTRIBUTION: Nationwide and Worldwide
QUANTITY: 222,022
PRODUCT AND CODE: COBE Cardioplegia Delivery
Sets (may also be labeled as the Sorin brand, the Dideco brand or be contained
in COBE Heart Lung packs).
Codes:
Part
# Lot #
032746002 11FO147, 12F0392,0101100069, 0106900012
020947601 12F0811MP
027812201 03F0641, 05F0502, 07F0610, 09F0729,
10F0678, 10F0679, 12F0585, 12F0584, 0102900082, 0108900150
027819201 03F0607, 07F0563, 09F0571, 10F0640,
11F0536, 12F0575, 12F0623, 12F0735, 0100300115, 0102200123, 0103600060,
0104000060,
0104600104, 0109500149, 0111000065, 0111600084.
067239001 0109300036
078722004 0107400098, 0109500184, 0113000058,
0100300153
078838003 09F0002, 11F0003, 0103600100,
0105700186, 0107400102.
078860004 01G0087, 01G0001.
078920001 0105700236
078939001 0110100019
078722002 03F0232, 06F0159, 08F0011, 08F0348,
10F0368, 11F0348.
027816201 05F0571, 07F0565, 08F0654, 09F0631.
027840201 01F0595, 02F0715.
025735403 10F0529MP.
REASON: Tubing subassembly assembled with wrong size
tubing.
MANUFACTURER/RECALLING FIRM: COBE CARDIOVASCULAR, INC.
ARVADA, CO
DISTRIBUTION: Nationwide, Canada and Italy
QUANTITY: 2566 sets
PRODUCT AND CODE: Human Dura Mater
Allograft, packaged in bottles, and labeled in part: "HUMAN FREEZE DRIED
ETHYLENE OXIDE STERILIZED DURA MATER" Codes: This code is on the label as "Deposit Number:", front
face.
D-17048-000-1998
D-17049-000-1998
D-17050-000-1998
D-17051-000-1998
D-17053-000-1998
D-17126-000-1998
D-17131-000-1998
D-17212-000-1998
D-17213-000-1998
D-17214-000-1998
D-17216-000-1998
D-17217-000-1998
D-17218-000-1998
D-17219-000-1998
D-17220-000-1998
D-17230-000-1998
D-17231-000-1998
D-17232-000-1998
D-17233-000-1998
D-17282-000-1998
D-17283-000-1998
D-17284-000-1998
D-17285-000-1998
D-17286-000-1998
D-17287-000-1998
D-17307-000-1998
D-17308-000-1998
D-17309-000-1998
D-17346-000-1998
D-17347-000-1998
D-17348-000-1998
D-17349-000-1998
D-17350-000-1998
D-17359-000-1998
D-17360-000-1998
D-17361-000-1998
D-17362-000-1998
D-17363-000-1998
D-17364-000-1998
D-17387-000-1998
D-17388-000-1998
D-17389-000-1998
D-17390-000-1998
D-17391-000-1998
D-17530-000-1998
D-17531-000-1998
D-17532-000-1998
D-17533-000-1998
D-17534-000-1998
D-17535-000-1998
D-17536-000-1998
D-17551-000-1998
D-17552-000-1998
D-17553-000-1998
D-17554-000-1998
D-17555-000-1998
D-17556-000-1998
D-17557-000-1998
D-17558-000-1998
D-17559-000-1998
D-17579-000-1998
D-17580-000-1998
D-17581-000-1998
D-17582-000-1998
D-17612-000-1998
D-17613-000-1998
D-17614-000-1998
D-17615-000-1998
D-17625-000-1998
D-17626-000-1998
D-17627-000-1998
D-17628-000-1998
D-17629-000-1998
D-17630-000-1998
D-17675-000-1998
D-17676-000-1998
D-17677-000-1998
D-17678-000-1998
D-17679-000-1998
D-17680-000-1998
D-17699-000-1998
D-17700-000-1998
D-17701-000-1998
D-17707-000-1998
D-17708-000-1998
D-17709-000-1998
D-17710-000-1998
D-17730-000-1998
D-17731-000-1998
D-17756-000-1998
D-17761-000-1998
D-17762-000-1998
D-17763-000-1998
D-18320-000-1998
D-18321-000-1998
D-18322-000-1998