SEPTEMBER 2002
WEEK ENDING SEPTEMBER 7
PRODUCT
Sterile Laceration Tray, product code 50-10890, packaged in sterile tray, 30
trays\case.
CODE Lot number 324580.
RECALLING FIRM/MANUFACTURER Recalling Firm: Deroyal Industries, Inc., Powell,
TN.
Manufacturer:
Deroyal Wound Care, Rose Hill, VA.
REASON Defective seals on surgical trays compromise device sterility.
VOLUME OF PRODUCT IN COMMERCE 90 trays.
DISTRIBUTION GA.
PRODUCT
Buffered Iontophoretic Delivery Electrode System, non-sterile, single-use only,
packaged in a metalized mylar bag, 12 per box.
IO-Drive Iontophoresis Electrode System. The product consists of 1 active drug
delivery electrode, 1 return electrode, 1 or 2 alcohol swabs, and an
instruction manual. The device is sold as a kit that is non-sterile and
intended for single-use only.
The kits contain one of three sizes of the active electrode (small, medium, or
large).
The medical device is sold under the 'Selective Med Components' label and
several private labels as follows:
1) Buffered Iontophoretic Delivery Electrode System; North Coast Medical, Inc.
2) Buffered Iontophoretic Delivery Electrode System, EMSI, Tampa, Florida.
3) Buffered Iontophoretic Delivery Electrode System; MedPend, Inc., Lake Mary,
FL.
4) Buffered Iontophoretic Delivery Electrode System; Rudolph Medical.
5) Buffered Iontophoretic Delivery Electrode System; Physio Tech.
6) Buffered Iontophoretic Delivery Electrode System; Spectramed.
7) IoDOSE Buffered Iontophoretic Delivery Electrode System; MagMed, Inc.
8) SUPER-TRODES Buffered Iontophoretic Delivery Electrode System; SME, Inc.
9) Buffered Iontophoretic Delivery Electrode System; Selective Med Components.
10) IONTO-Clone Buffered Iontophoretic Delivery Electrode System; New England
Surgical, Inc.
CODE Lot Numbers: 5129-1, 5130-1, 5131-1, 5291-1, 5292-1, 5293-1, 5368-1,
5369-1, 5370-1, 5573-1, 5574-1, 5575-1, 5684-1, 5685-1, 5686-1, 5946-1, 5947-1,
5948-1, 6483-1, 6484-1, 6487-1, 6711-1, 6712-1, 6713-1, 7030-1, 7031-1, 7032-1,
7427-1, 7428-1, 7429-1, 7513-1, 7514-1, and 7515-1.
RECALLING FIRM/MANUFACTURER Selective Med Components, Inc., Mt. Vernon, OH.
REASON The device may cause skin burns.
VOLUME OF PRODUCT IN COMMERCE 70,000 kits.
DISTRIBUTION FL, MS, OH, MA, CA, VA, and NC.
PRODUCT
Storz brand Concentrix Phacoemulsification Pack, Labeled as Sterile. Product or
reference number CX4310.
CODE Lot Number: S7825.
RECALLING FIRM/MANUFACTURER Bausch & Lomb Surgical, Inc., Clearwater, FL.
REASON Irrigation line tubing may not properly adhere to the casette and leak or
detach.
VOLUME OF PRODUCT IN COMMERCE 600 (100 boxes/6 units each).
DISTRIBUTION Nationwide and Australia, Canada and The Netherlands.
WEEK ENDING SEPTEMBER 21
PRODUCT
SSCOR Suction Unit Model 2314; SSCOR Suction Unit Model 2314B; SSCOR Suction
Unit Model 2315.
CODE All Codes.
RECALLING FIRM/MANUFACTURER Sscor, Sun Valley, CA.
REASON Overheats and fails to suck.
VOLUME OF PRODUCT IN COMMERCE 4105.
DISTRIBUTION Nationwide and Saudi Arabia.
PRODUCT
Vanish Point Blood Collection Tube Holder, packaged 10 units per sleeve, 25
sleeves per case.
CODE 11 lots recalled: RTI Lot number/Abbott Lot number D152A/700126S;
D158A/710166S; D166A/720076S; D167A/720086S; D169A/720146S; D170A/720196S;
D171A/720206S; D172A/730046S; D173A/730056S; D174A/730126S; D181A/730286S.
RECALLING FIRM/MANUFACTURER Retractable Technologies, Inc., Little Elm, TX.
REASON Unexpected premature retraction is possible.
VOLUME OF PRODUCT IN COMMERCE 951,750 units.
DISTRIBUTION Nationwide and Canada and Africa.
PRODUCT
Misys Laboratory.
CODE Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems Inc., Tuscon, AZ.
REASON Software anomaly regarding cell counts.
VOLUME OF PRODUCT IN COMMERCE 469.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT
LIFEPAK 12 defibrillator/monitor. The particular part is the therapy connector
- this connector allows hard paddles, disposable electrode cables, or
internal-paddle cables to be easily connected or disconnected to the device.
CODE Serial numbers are non-continuous and can be obtained from the SEA-DO
Recall Coordinator.
RECALLING FIRM/MANUFACTURER Medtronic Physio-Control Corp., Redmond, WA.
REASON Potential for interrupted pacing or defibrillator functions.
VOLUME OF PRODUCT IN COMMERCE 5494.
DISTRIBUTION Nationwide.
PRODUCT
Model 8870 Software Application Card for the Model 8840 N’Vision Handheld
Clinician programmer.
CODE All units are involved.
RECALLING FIRM/MANUFACTURER Medtronic, Inc., Neurological Division,
Minneapolis, MN.
REASON An incorrect drug administration rate can be programmed into SynchroMed
or SynchroMed EL implantable infusion pumps due to defective software.
VOLUME OF PRODUCT IN COMMERCE 34 Model 8870 Application Cards.
DISTRIBUTION Europe and the Middle East.
PRODUCT
Mysis Commercial Laboratory
CODE Versions 3.2.0; 3.2.2; 3.2.3, 3.3.0, 3.3.1a, 3.3.1, 3.4.0, 3.4.1b, and
3.4.1a.
RECALLING FIRM/MANUFACTURER Mysis Healthcare Systems, Inc., Plano, TX.
REASON Software anomaly: a result for an accesion number came across the
interface as negative but should have been Do Not Result (DNR).
VOLUME OF PRODUCT IN COMMERCE 44
DISTRIBUTION Nationwide.
PRODUCT
HP Deskjet 970Cxi Printer connected as an accessory to the Elan ATAC 8000
Random Chemistry
CODE
HP Deskjet 970Cxi Printer connected as an accessory to the Elan ATAC 8000
Random Chemistry Analyzer.
RECALLING FIRM/MANUFACTURER Elan Diagnostic Smithfield, RI
REASON Printer power cord may crack and cause electric shock.
VOLUME OF PRODUCT IN COMMERCE 29
DISTRIBUTION Nationwide
PRODUCT
VACUTAINER Brand Luer Adapters (Catalog #367290).
CODE Catalog #367290 Lot #'s 1242595 and 1284859.
RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson & Co.,
Franklin Lakes, NJ.
Manufacturer: Becton Dickinson & Co., Sumter, SC
REASON Needle Separated from the Hub.
VOLUME OF PRODUCT IN COMMERCE 3,690,000 units estimated in commerce.
DISTRIBUTION Nationwide.
PRODUCT
Power supply cord sold with and used with Spacelabs Medical Models 90342,
90344, 90346, 90348, and 90479 telemetry systems/receiver housings.
CODE All codes.
RECALLING FIRM/MANUFACTURER Recalling Firm: Spacelabs Medical, Inc., Redmond,
WA.
Manufacturer:
Winegard Company, Burlington, IA.
REASON Power supply cord not UL or CSA approved.
VOLUME OF PRODUCT IN COMMERCE 759 power supplies.
DISTRIBUTION Nationwide.
PRODUCT
Misys Commercial Laboratory.
CODE Versions 3.3.0, 3.3.1, 3.4.0 and 3.4.1a.
RECALLING FIRM/MANUFACTURER Mysis Healthcare Systems, Inc., Plano, TX.
REASON Software anomaly. If the deformatter begins to process data prior to all
patient result records or orders being extracted from the flat files, the
remaining results or orders will not be extracted. This can result in data
being processed out of sequence into the Mysis Commercial Laboratory System.
VOLUME OF PRODUCT IN COMMERCE 7.
DISTRIBUTION TX, FL, NY, MN, NC and PA.
PRODUCT
a) MediSense ExacTech Blood Glucose Test Strips (50 Count); b) MediSense
ExacTech Blood Glucose Test Strips (100 Count);
c)
MediSense ExacTech RSG Blood Glucose Test Strips(50 Count)
CODE a) Lot Number: 45874; b) Lot Number: 45874; c) Lot Number: 45852.
RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Inc.,
Medisense Products, Bedford, MA.
Manufacturer: Medisense UK Limited Abingdon Oxon.
REASON Blood Glucose Test Strip May Give False High Readings.
VOLUME OF PRODUCT IN COMMERCE 6,241 Boxes (50 test strips/box).
DISTRIBUTION Nationwide.
PRODUCT
Optetrak 1/2 Tibial Augmentation Block Implants, (Classification name: knee
joint patellofemoral polymer/metal/polymer semi-constrained). Product is
intended to be implanted during total knee joint replacement surgery where
augmentation of the standard implant components is required.
CODE All serial numbers less than 0260014 for the following products:
|
Part
Description |
Catalog
Number |
|
1/2
Tibial Augmentation Block, Sz 0 X 5 mm |
204-60-05 |
|
1/2
Tibial Augmentation Block, Sz 0 X 8 mm |
204-60-08 |
|
5mm
Tibial Augmentation 1/2 Block Sz.1 |
204-61-05 |
|
8mm
Tibial Augmentation 1/2 Block Sz.1 |
204-61-08 |
|
11mm
RL, LM Tibial Augmentation 1/2 Block Sz.1 |
204-61-88 |
|
11mm
RM, LL Tibial Augmentation 1/2 Block Sz.1 |
204-61-89 |
|
5mm
Tibial Augmentation 1/2 Block Sz.2 |
204-62-05 |
|
8mm
Tibial Augmentation 1/2 Block Sz.2 |
204-62-08 |
|
11mm
RL, LM Tibial Augmentation 1/2 Block Sz.2 |
204-62-88 |
|
11mm
RM, LL Tibial Augmentation 1/2 Block Sz.2 |
204-62-89 |
|
5mm
Tibial Augmentation 1/2 Block Sz 3 |
204-63-05 |
|
8mm
Tibial Augmentation 1/2 Block Sz 3 |
204-63-08 |
|
11mm
RL, LM Tibial Augmentation 1/2 Block Sz 3 |
204-63-88 |
|
11mm
RM, LL Tibial Augmentation 1/2 Block Sz 3 |
204-63-89 |
|
5mm
Tibial Augmentation 1/2 Block Sz 4 |
204-64-05 |
|
8mm
Tibial Augmentation 1/2 Block Sz 4 |
204-64-08 |
|
11mm
RL, LM Tibial Augmentation 1/2 Block Sz 4 |
204-64-88 |
|
11mm
RM, LL Tibial Augmentation 1/2 Block Sz 4 |
204-64-89 |
|
5mm
Tibial Augmentation 1/2 Block Sz 5 |
204-65-05 |
|
8mm
Tibial Augmentation 1/2 Block Sz 5 |
204-65-08 |
|
11mm
RL, LM Tibial Augmentation 1/2 Block Sz 5 |
204-65-88 |
|
11mm
RM, LL Tibial Augmentation 1/2 Block Sz 5 |
204-65-89. |
RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL
REASON
Compromise of sterility barrier packaging.
VOLUME OF PRODUCT IN COMMERCE 1828.
DISTRIBUTION Nationwide.
PRODUCT
Hill-Rom brand Affinity Three birthing bed.
CODE All beds with a serial number of D196AA4617 or lower.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN.
REASON Calf support mounting screws may loosen and back out, allowing the calf
support to become unstable/fall off.
VOLUME OF PRODUCT IN COMMERCE 4,473 beds.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
Stryker Howmedica Osteonics V40TM Femoral Head, 26mm Diameter, (5o40’ Taper).
CODE Device : V40TM Femoral Head, 26mm Diameter, (5o40’ Taper) Catalog #:
6260-5-226 Lot #’s: BZDJPR, BZEHYR,
CABHVR, CABHWR, CABPZR, CABRCR, CABRDR, CABRER, CACNGR, CAFFKR, CAFFLR, CAFFNR,
CAFFPR, CAFFRR, CAFFSR, CAFFUR, CAGBMR, CAGBNR, CAGBOR, CAGBRR, CAGBSR, CAGBVR,
CAGBWR, CAGSJR, CAGSKR, CAGSNR, CAHMER, CAHMFR, CAHUWR, CAHUYR, CAJEPR, CAJERR,
CAJESR, CAJETR, CASUBR, CATJKR, CATJLR, CAVFMR, CAVFNR, CAVGBR, CAVGDR, CAVGDR,
CAVMSR, CAVMTR, CAVMUR, CAWKOR
Expiration Dates: 12/2006 (Lot #’s: CABHWR, CAGBWR, CAHMFR, CAJEPR, CAJERR,
CAJESR, CAJETR)
1/2007 (Lot #’s BZDJPR, BZEHYR, CABHVR, CABPZR, CABRCR, CABRDR, CABRER, CACNGR,
CAFFKR, CAFFLR, CAFFNR, CAFFPR, CAFFRR, CAFFSR, CAFFUR, CAGBMR, CAGBNR, CAGBOR,
CAGBRR, CAGBSR, CAGBVR, CAGSJR, CAGSKR, CAGSNR, CAHMER, CAHUWR, CAHUYR) 2/2007
(Lot #’s CASUBR, CATJKR, CATJLR, CAVFMR, CAVFNR, CAVGBR, CAVGDR, CAVGDR,
CAVMSR, CAVMTR, CAVMUR, CAWKOR) Device: 2o52’ Taper Femoral Head, 26mm Diameter
+0mm
Catalog #: 6280-0-126 Lot #’s: 6089722R, 6314756R, 6877383R, 6902451R,
6902452R, 6978671R, 6978672R, CADULR, CADUMR, CAJDER, CAJDHR, CAJHIR Expiration
Dates: 1/2007 (Lot #’s 6089722R, 6877383R, 6902451R, 6902452R, 6978671R,
6978672R, CADULR, CADUMR, CAJDER, CAJDHR, CAJHIR) 3/2007 (Lot # 6314756R)
RECALLING FIRM/MANUFACTURER Howmedica Osteonics Corp., Rutherford, NJ.
REASON Product mix up. Skirted heads in Non-skirted packaging.
VOLUME OF PRODUCT IN COMMERCE 125.
DISTRIBUTION NJ.
PRODUCT
a) Stryker Howmedica Osteonics Unitrax® C-Taper Neck Adjustment Sleeve (Adapter
for Unipolar Head). b) Stryker Howmedica Osteonics Unitrax® V40TM Std. Sleeve
5o 40’ Modular Adapter (Neck Adjustment Sleeve.
CODE
a) Unitrax® C-Taper Neck Adjustment Sleeve 6942-7-065 Lot 7153061
b) Unitrax® V40TM Std. Sleeve 5o 40’ Modular Adapter 6942-6-065 Lot 7153072
RECALLING FIRM/MANUFACTURER Howmedica Osteonics Corp., Rutherford, NJ.
REASON Product package mixup. Incorrect taper.
VOLUME OF PRODUCT IN COMMERCE 38.
DISTRIBUTION NJ and Canada.
PRODUCT
Flexima Ureteral Stent System Kit as follows: See Code Section.
CODE Boston Scientific/Medi-Tech Flexima RegularUreteral Stent System Kit as
follows:
|
Catalog
# |
Product |
Lots
Affected |
|
27-410 |
USK/6/20/Reg |
3309365 |
|
27-411 |
USK/6/22/Reg |
3007121 |
|
27-412 |
USK/6/24/Reg |
3073644 |
|
27-413 |
USK/6/26/Reg |
3089476 |
|
27-414 |
USK/6/28/Reg |
3480624 |
|
27-415 |
USK/8/20/Reg |
3075354 |
|
27-416 |
USK/8/22/Reg |
2984060 |
|
27-417 |
USK/8/24/Reg |
3136719 |
|
27-418 |
USK/8/26/Reg |
3251321 |
|
27-419 |
USK/8/28/Reg |
3142848 |
RECALLING FIRM/MANUFACTURER Recalling Firm: Boston Scientific Corp./Medi-Tech,
Watertown, MA.
Manufacturer: Medi-Tech, a division of Boston Scientific Corp., Spencer, IN.
REASON Outer carton multi language label incorrectly identifies the device as
Biliary instead of Ureteral Stent.
VOLUME OF PRODUCT IN COMMERCE 946.
DISTRIBUTION The Netherlands.
PRODUCT
a) Cryosurgery System-Welch Allyn; b) LM-900 Leisegang Cryosurgery System.
CODE a) Cryosurgery System-Welch Allyn Catalog No. 88372 Serial Numbers: 010201
to 050215; 110101 to 110103
b) LM-900 Leisegang Cryosurgery System
Catalog Number: 50501 and 50502 Serial Numbers: 12744 to 13500.
RECALLING FIRM/MANUFACTURER Coopersurgical, Inc., Trumbull, CT
REASON
Tip may separate from Cryogun when pressure is released during operation.
VOLUME OF PRODUCT IN COMMERCE 767.
DISTRIBUTION Nationwide and Canada, Guatamala, Costa Rica, Mexico, Manila and
Istanbul.
PRODUCT
a) Microstream Smart CapnoLine Oral/Nasal O2/CO2 Cannula; b) Microstream Smart
CapnoLine Nasal O2/CO2 Cannula;
c) MAC-Line Smart Oral Nasal 02/CO2
Cannula; d) MAC-Line Smart Nasal O2/C02Cannula.
CODE
Description Oridion PN
O2/CO2
Nasal FilterLine Adult 006912
O2/CO2
Nasal FilterLine Adult Long 007739
O2/CO2
Nasal FilterLine Pediatric 006913
O2/CO2
Nasal FilterLine Pediatric Long 007740
Smart
CapnoLine Adult 007264
Smart
CapnoLine Intermediate 007265
Smart
CapnoLine Pediatric 007266
Smart
CapnoLine O2 Adult 007267
Smart
CapnoLine O2 Adult Long 007741
Smart
CapnoLine O2 Intermediate 007268
Smart
CapnoLine O2 Intermediate Long 007742
Smart
CapnoLine O2 Pediatric 007269
Smart
CapnoLine O2 Pediatric Long 007743
Smart
MacLine Adult 007601
Smart
MacLine Intermediate 007602
Smart
MacLine Pediatric 007603
Smart
MacLine O2 Adult 007604
Smart
MacLine O2 Intermediate 007605
Smart
MacLine O2 Pediatric 007606
Nasal
MacLine O2 Adult 007609
Nasal
MacLine O2 Pediatric 007610
PRIVATE
LABEL:
Nellcor
Puritan Bennet US & Tyco Europe (OEM)
Description Oridion PN NPB PN
O2/CO2
Nasal FilterLine Adult 006899 063568
O2/CO2
Nasal FilterLine Pediatric 006900 063569
Smart
CapnoLine Adult 007341 064093
Smart
CapnoLine Intermediate 007342 064094
Smart
Capnoline Pediatric 007343 064095
Smart
CapnoLine O2 Adult 007344 064842
Smart
CapnoLine O2 Intermediate 007345 064843
Smart
CapnoLine O2 Pediatric 007346 064844
PRIVATE
LABEL:
MPC
(Medtronic PhysioControl Corp) (OEM)
Description Oridion PN MPC PN
O2/CO2
Nasal FilterLine Adult 006903 006903
O2/CO2
Nasal FilterLine Pediatric 006905 006905
Smart CapnoLine Adult 007354 007354
Smart CapnoLine Intermediate 007355 007355
Smart Capnoline Pediatric 007356 007356
Smart CapnoLine O2 Adult 007357 007357
Smart CapnoLine O2 Intermediate 007358 007358
Smart CapnoLine O2 Pediatric 007359 007359
RECALLING FIRM/MANUFACTURERORIDION MEDICAL LTD.,
Jerusalem.
REASONOral Nasal Cannula missing holes for the delivery of supplemental oxygen.
VOLUME OF PRODUCT IN COMMERCE8668 cases (25 units/cs).
DISTRIBUTION Nationwide.
PRODUCT LCx Neisseria gonorrhoeae Assay, Amplification &
Detection Kit, 96 tests.
CODE All lots list 8A48-81: lots 84073M400, 84075M400,
84142M300, 84146M300, 85099M300, 85487M20085488M200, 85489M200
list
8A48-82: lots 86800M300, 87007M400,
87103M400, 87225M100, 87240M100, 87243M100, 87376M200, 87377M200, 87378M200,
87818M100,
87899M200,
87905M200, 88097M300, 88105M300, 88106M300, 88107M300, 88110M300, 88111M300,
88439M200, 88439M201, 88556M300, 88850M300, 89177M300, 89187M100.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc.,
Abbott Park, IL
REASON May not meet sensitivity specifications.
VOLUME OF PRODUCT IN COMMERCE 15,084.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Diagnost 88 with a monitor support arm
9804-404-10X03, 9804-404-40X03 [where X is any number 0-9].
CODE Diagnost 88 with a monitor support arm
9804-404-10X03, 9804-404-40X03 [where X is any number 0-9]
RECALLING FIRM/MANUFACTURER Philips Medical Systems
North America, Inc., Shelton, CT
REASON Monitor may fall due to failure of support arm.
VOLUME OF PRODUCT IN COMMERCE 6.
DISTRIBUTION MS, NJ and NY.
PRODUCT Trade name: EmpowerCT Injector System, Model/Catalog
#: 9800. Legally Marketed Name: PercuPump II with EDA CT Injector
CODE Injectors Affected by the "Service
Advisory" with software version 1.02a or earlier have serial numbers
P61012 – P61076. The system can be configured with various accessories which
include the following catalog numbers: 9830, 9820, 9825, 9870, 9850, 9851, 9852,
9853, 9855, 9856, 9857, 9858, 9860, 9871, 9875, 9876, 9877, 9885S M & L,
9886S M & L, 9887, 9888, 9895, 9896, 6720, 7881.
RECALLING FIRM/MANUFACTURER E-Z-EM, Inc., Westbury, NY.
REASON Software anomaly can cause excess contrast agent to
be injected during test injection.
VOLUME OF PRODUCT IN COMMERCE 61 units.
DISTRIBUTION Nationwide.
PRODUCT Opera & Tempo Patient Lifts, Non-AC Powered:
a)
model KPB3500-21US - Opera Combi;
b)
model KPB3002-21US - Opera Combi with Scale;
c)
model KPB3100-22US - Opera PPP (Power Patient Positioning);
d)
model KPB3160-22US - Opera PPP with Scale;
e)
model KPB5100-23US - Tempo PPP (Power Patient Positioning);
f)
model KPB5150-23US - Tempo PPP with Scale;
g)
model KPB5000-23US - Tempo with 4 Point Hanger Bar;
h)
model KPB5050-23US - Tempo with 4 Point Hanger and Scale.
CODE Opera Patient Lifts with serial numbers prior to
GB2002896045002; Tempo Patient Lifts with serial numbers prior to
GB1902895367001.
RECALLING FIRM/MANUFACTURER Recalling Firm: Arjo, Inc.,
Roselle, IL.
Manufacturer:
Arjo Ltd., Gloucester, United Kingdom.
REASON Hanger bar and jib may detach from the patient lift.
VOLUME OF PRODUCT IN COMMERCE 660 lifts.
DISTRIBUTION Nationwide.
PRODUCT Becton Dickinson's EpiCenter Data Management System
software.
CODE EpiCenter Software, version 3.20B, Catalog #441007.
RECALLING FIRM/MANUFACTURER Becton Dickinson
Microbiology Systems, Sparks, MD
REASON IVD software defect may cause incorrect patient
results to be reported.
VOLUME OF PRODUCT IN COMMERCE 336 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT SurgAssist Circular Stapler DLU, Digital Loading
Unit. The device is a single use sterile device. The device has 24 implantable
titanium staples with it. The device is individually packaged and sold/shipped
6 devices per box.
CODE SurgAssist CS29, Circular Stapler DLU, 29mm -
lots: DS000103; DS000105; DS000108 and
DS000110.
SurgAssist
CS33, Circular Stapler DLU, 33mm - lots: DS000009; DS000014; DS000020;
DS000022; DS000025; DS000029; DS000031; DS000034; DS00003 5; DS000060;
DS000066; DS000067; DS000074; DS000079; DS000080; DS000098; DS000101 and
DS000109.
RECALLING FIRM/MANUFACTURER Power Medical Interventions,
Inc., New Hope, PA
REASON Does not complete firing cycle.
VOLUME OF PRODUCT IN COMMERCE 1080 units.
DISTRIBUTION Nationwide and Germany, Italy and Ireland.
PRODUCT Tosoh brand AIA-PACK Progesterone Calibrator Set.
CODE Catalog # 020381, Lot # C332226, Expiration Date
3/2003.
RECALLING FIRM/MANUFACTURER Recalling Firm: Tosoh Medics,
Inc., South, San Francisco, CA
REASON This product does not meet the stated claim for
shelf life stability.
VOLUME OF PRODUCT IN COMMERCE 35.
DISTRIBUTION Nationwide and Internationally.
PRODUCT The Power Cord from the printer that may be sent as
an accessory to the Architect i2000 System or Abbott Commander.
CODE Not specified.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc.,
Irving, TX
REASON Power Cord recalled from Supplier.
VOLUME OF PRODUCT IN COMMERCE 337.
DISTRIBUTION Nationwide and Singapore, Hong Kong and
Korea.
PRODUCT Exactech brand AcuDriver Carbide punch, long, Model
Name Carbide punch, sterile, Catalog Number 400-40-25.
CODE Serial Numbers 0105608-0105621.
RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville,
FL
REASON Sterility barrier may be compromised in some
packaging.
VOLUME OF PRODUCT IN COMMERCE 8.
DISTRIBUTION FL, LA, MN, ME, NY, NV AND WA.
PRODUCT Huber Plus Safety Infusion Set, product code MM
2034. The proprietary name is Huber Plus Safety Infusion Set and the common
name is Huber Needle and Administration Set.
CODE Lot number 2D018MK.
RECALLING FIRM/MANUFACTURER Now Medical Distribution
Inc., West Chester, PA
REASON Device labeled with incorrect gauge size.
VOLUME OF PRODUCT IN COMMERCE 4575 units.
DISTRIBUTION CA, KS, MN, NY, OH, PA and WA.
PRODUCT Premier HSV, an EIA diagnostic test kit, packaged
under the Meridian Premier brand label.
CODE --- Premier HSV kits ---
Lot
Numbers and Exp. Dates:
#550010.079,
Exp. 02 Aug 02
#550010.080,
Exp. 02 Aug 02
#550010.082,
Exp. 26 Jul 02
The
catalog number is #550010. --- OPD Substrate Tablets (kit component) --- Lot
Number: 9677.043
RECALLING FIRM/MANUFACTURER Meridian Bioscience, Inc.,
Cincinnati, OH
REASON The OPD Substrate Tablets have deteriorated due to
moisture, and may result in inaccurate test results.
VOLUME OF PRODUCT IN COMMERCE 594 kits (lot .07930; lot
.080 2; lot .082 2).
DISTRIBUTION Nationwide.
PRODUCT Focus Night and Day extended wear contact lens
CODE Lot 2517083.
RECALLING FIRM/MANUFACTURER Recalling Firm: Ciba Vision
Corp., Duluth, GA
REASON A 2-Week Focus lens found inside carton of Focus
Night and Day lens.
VOLUME OF PRODUCT IN COMMERCE 933/six-pack cartons.
DISTRIBUTION Nationwide and Internationally.