SEPTEMBER 2005
WEEK ENDING SEPTEMBER 3
PRODUCT Optetrak Finned Tibial
Tray A/P 53 mm ML 83mm***4F/5T Ti Alloy Fits only SZ. 4 Femoral Cemented,
Sterile, Single Use Only. For Cemented Use Only
CODE Serial number range 0696020 --
0696061.
RECALLING FIRM/MANUFACTURER Exactech, Inc, Gainesville, FL
REASON
Implant was identified incorrectly at the time of
manufacture and then laser etched with the incorrect size
information.
VOLUME OF PRODUCT IN COMMERCE 41
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Accura System for Blood
Filtration, product codes 5M5660 and ACCURA01 (international), a hemofiltration
system
CODE All serial numbers
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div, Mc Gaw
Park, IL
Manufacturer: Mesys Gmbh, Hannover, Germany.
REASON
In the
event therapy is terminated, as part of routine instrument programming or
therapy maintenance, the Accura instrument may experience difficulty in
performing a successful self-test (failure) upon an immediate attempt to restart
therapy.
VOLUME OF PRODUCT IN COMMERCE 264
units
DISTRIBUTION Nationwide, China and Belgium
PRODUCT
a) Staarvisc II Sodium
Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile, Rx, For intraocular use. P/N490-001,
b) ShellGell Sodium Hyaluronate 0.8mL
Syringe, 12 mg/mL, Sterile, Rx. For intraocular use. Product Number: 1000
c)
Amvisc® Sodium Hyaluronate 0.5 mL, Product
Number: 59051
d) Amvisc® Sodium Hyaluronate 0.8 mL,
Product Number: 59081
e) Amvisc® Plus Sodium
Hyaluronate 0.5 mL, Product Number: 60051
f) Amvisc®
Plus Sodium Hyaluronate 0.8 mL, Product Number: 60081
CODE
a) Lot Numbers: B041118C, B050510A;
b) Lot
Numbers: B041118E, B041118F, B050510C;
c) Lot Numbers: C050510A,
C050510;
d) Lot Numbers: B050510B; B050120B, B040616R;
e) Lot Numbers:
C050405, C050405A;
f) Lot Numbers: B050405A, B050428,
B040930R
RECALLING FIRM/MANUFACTURER Anika Therapeutics, Inc.,
Woburn, MA
REASON Product sterility may be compromised due incomplete
heat seals in the cannula pouches that are included with the viscoelastic
syringe.
VOLUME OF PRODUCT IN COMMERCE Over 30,000
units
DISTRIBUTION CA and NC
PRODUCT Access Immunoassay
Systems Assay Protocol: Dil-AFP,
CODE All Lot
numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman
Coulter, Inc., Brea, CA,
Manufacturer: Beckman
Coulter, Inc, Chaska, MN.
REASON Pipetting for dil-Alpha-fetoprotein when performed
on the Access, Access 2 and Synchron LX I 725 has a potential to create
splashing which may cause erroneous results.
VOLUME OF PRODUCT IN
COMMERCE 311 USA; 16 Canada
DISTRIBUTION Nationwide and
Canada
PRODUCT
a) Stryker brand
Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000,
b)
Stryker brand Consolidated Operating Room Equipment (CORE) System Powered
Instrument Driver, REF 5400-50; Model 5400-050-000A,
CODE
a) All units manufactured July 22, 2005
through
July 25, 2005;
b) All units manufactured June 23, 2005 through July 22,
2005
RECALLING FIRM/MANUFACTURER Stryker Instruments, Div. Of
Stryker Corporation, Kalamazoo, MI
REASON Potential electrical shock
hazard, in that the potential exists for the patient to be exposed to an
earth-referenced electrical current.
VOLUME OF PRODUCT IN
COMMERCE
a) 25 units;
b) 27 units
DISTRIBUTION VA,
Australia, Canada, England, France, Germany, Japan, Netherlands, Sweden, and
Switzerland
PRODUCT Hemochron Jr. Whole
Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil
pouches. 45 foil pouches per shelf carton box
CODE Catalog No. JACT-LR Lot No's: M4JLR164, Exp. 3/2006;
M4JLR165, Exp. 3/2006; A5JLR001, Exp. 4/2006; A5JLR002, Exp. 4/2006; A5JLR003,
Exp. 4/2006; C5JLR032, Exp. 6/2006.
RECALLING
FIRM/MANUFACTURER International Technidyne Corp, Edison, NJ
REASON
Validation
had been initiated for a molded component of the finished device but not
completed. Also, the device did not meet mean clotting time using Normal Donor
Blood as media.
VOLUME OF PRODUCT IN COMMERCE 924 boxes x 45
cuvettes per box
DISTRIBUTION Nationwide and Internationally
PRODUCT ABBOTT TestPack +Plus
hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20
reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal)
coated; CODE List number 7B34-16, lot numbers
16006M200 and 19199M300
RECALLING FIRM Abbott
Laboratories MPG, Abbott Park, IL
REASON False Positive results may be obtained
with the identified lots of list 7B34-16 when using a negative patient sample or
a negative control.
VOLUME OF PRODUCT IN COMMERCE 7,607
kits
DISTRIBUTION Canada, Germany, Hong Kong and Australia
PRODUCT NAMIC Custom
Angiographic Kit: (1) Pouch Catalog # 60131481; (2) Pouch Catalog #60131603; (3)
Pouch Catalog #60101041; (4) Pouch Catalog #61020031 (5) Kit #65185472 ******
Each kit is customized to the needs of the particular hospital identified on the
product labeling,
CODE
1) Lot 942414
2) Lot
939982, 943645;
3) Lot 940424;
4) Lot 940054;
5) Lot 945456;
943043
RECALLING FIRM/MANUFACTURER Boston Scientific Corporation,
Glens Falls, NY
REASON Molded handles used in Angiographic Manifolds may
be occluded.
VOLUME OF PRODUCT IN COMMERCE 1,115
kits
DISTRIBUTION IL, KY, MI, SC, and TX
WEEK ENDING SEPTEMBER 10
PRODUCT
a) Baxter System 1000
Single Patient Hemodialysis Systems, product codes SYS1000L3, SYS1000L3P,
SYS1000L3T, SYS1000L3TD, SYS1000L2C2;
b) Baxter
Arena Hemodialysis Systems, product codes ARENADPX, ARENASP, ARENADPP, ARENASPX;
CODE
All serial
numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Baxter Healthcare Corp., Deerfield, IL
Manufacturer: Baxter Healthcare Corp., Largo, FL.
REASON
Operator's Manuals addenda are
being issued to provide correct information concerning the correct syringe size
to use for heparin infusion, the use of chemical disinfectants in the System
1000, TMP Advise, and Bicarbonate Value calculations.
VOLUME OF PRODUCT IN
COMMERCE 15,540 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Aortic Cutter, single
use device consisting of grip, cutter, aortic stops, needle, safety lock and
actuation button,
CODE HSK-2038, HSK-2043. All
lots are affected by this recall.
RECALLING
FIRM/MANUFACTURER Guidant Cardiac Surgery, Santa Clara, CA
REASON Incomplete
or no aortotomy may occur with use of the aortic cutter on unaltered tissue, or
incomplete aortotomy may result when the cutter is used on altered tissue. Use
of the cutter on altered tissue has caused the aortic plug to not be captured by
the device.
VOLUME OF PRODUCT IN COMMERCE 7,391
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) MyLab30CV Ultrasound
Imaging System; model 9807300000,
b) MyLab30CV
Ultrasound Imaging System; model 9807300001,
c)
MyLab25 Ultrasound Imaging System; model 9807300002,
CODE
a) All units using software version 3.02:
Serial
numbers 53, 58, 60, 67, 70, 72, 73, 75 and 79;
b) All units using
software version 3.02: Serial numbers 102-112, 114-120, 122, 134-141,
149-167, 169, 172, 279-190, 196-210, 212-218, 220-222, 224-226, 228-247,
251-295, 317. 319. 322-329,
339, 340, 367, 368, 370-387, 393, 400, 410,
414-432, 478, 480-483, 485-488, 509-522 and 569-582;
c) All units using
software version 3.02: Serial numbers 530-539.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Biosound Esaote, Inc.,
Indianapolis, IN,
Manufacturer: Esaote Biomedica S.P.A., Firenze, Italy.
.
REASON Data maybe corrupted upon
re-opening archived files.
VOLUME OF PRODUCT IN COMMERCE 195
units
DISTRIBUTION Nationwide, Canada and Venezuela
PRODUCT Radiomat Lightweight
Cassettes, Product Code: EHYG2, Model: 14x17 Green RE 400 Screens and Cassettes,
Product Code: EHYCT, Model: 14x17 Green RE 100 Screens and Cassettes, Product
Code: EHX5C, Model: 14x17 Blue RE 800 Screens and Cassettes
CODE Batch number are a combination of 4 letters/numbers
xxyy, where xx varies alphabetically form 6N and 6Z and from 7A to &N and yy
is a number from 01 through 31. Batch numbers are located both on the cassette
shell and on the outer label.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: AGFA Corp, Greenville, SC
Manufacturer: Agfa-Gevart
NV, Mortsel, Belgium.
REASON Users of these cassettes may detect poor film to
screen contact and unsatisfactory sharpness of radiographic images.
VOLUME
OF PRODUCT IN COMMERCE 9,055 units
DISTRIBUTION Nationwide
and Canada
PRODUCT
a) ITW Dymon Medaphene
Plus Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal,
Staphylocidal, Tuberculocidal, packaged in 20-oz. steel
aerosol cans, net wt 16-oz. (1-lb.), 12 cans/case, containing 0.19%
o-phenylphenol and 68.00% ethyl alcohol, Product 34720. The firm name on
the label is ITW Dymon. The product is also sold under the following private labels:
(1) Renown Disinfectant Deodorant
II, Product REN05013,
Distributed by AmSan, LLC;
(2) Decon Aerosol Disinfectant, Catalog #8617;
(3) New Jax Medaphene Plus Disinfectant Spray;
(4) San-O-Phene Plus
Disinfectant Spray, Sold By San Joaquin Supply Co.;
(5) Sterling Quality
Hospital Use Micro II Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation;
(6)
Ball-Phene Spray Disinfectant, Reorder
#3U037;
(7) Area Two-In-One Disinfectant Spray Original, Sold By Area
Distributors, Inc.;
(8) Benefax Disinfectant Spray, Exclusively S Sold By
Biotek Corporation;
(9) Pheno-Cen Spray Disinfectant/Deodorant, Sold By Central Solutions, Inc.;
(10) Clark Bio-Phene Plus Disinfectant/Spray, Sold By Clark Paper Plus Inc.;
(11) LOGIChem Hosp-I-Septic Disinfectant
Spray, Distributed Exclusively For Edmar;
(12) Morcept Hospital
Disinfectant, Sold By Moore Research, Inc.;
(13) Pro Chem Deocept Purity
Hospital Disinfectant, Sold By Pro-Chem, Inc.,
(14) Select Specialty
Products Spectrum II Hospital Type Disinfectant, Sold By Select Specialty Products,
b)
ITW Dymon Medaphene Plus
Orange Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal,
Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel
aerosol cans, net wt 16-oz. (1-lb.), 12
cans/case, containing 0.19% o-phenylphenol and
68.00% ethyl alcohol, Product 52920. The firm
name on
the label is ITW Dymon. The product is also distributed under the following
private labels:
(1)O.D.S. Orange Disinfectant Spray, Continental Research
Corporation;
(2) Drummond American Bristol Orange Disinfectant Spray, Product DR8561, Sold by Drummond American Corporation;
(3) Romaine Medaphene Plus Disinfectant Spray Orange Fragrance, Manufactured For Romaine Companies; (4) State Discover Aerosol Disinfectant Citrus, Stock #109566 and #109567, Sold By State Industrial Products;
(5) Medisan Disinfectant Spray, Orange Scent, Distributed by Cape Janitor Supply;
(6) DETCO Industries Germ Defense Disinfectant Spray, Orange Fragrance, Sold by DETCO Industries;
(7) Orange Disinfectant Spray, Manufactured for MASSCO, Inc.;
(8) Meyer Tri Power, Sold By Meyer Laboratory Inc.;
(9) Orange Surfacidal Disinfectant Spray, Packed for Check Mark, A Division of DM Resources, Inc.;
(10) Citrus-Cidal Disinfectant Spray, Orange Fragrance, Sold By navy brand Manufacturing Company;
(11) Pro Chem Deocept Citra Disinfectant Spray, Orange Fragrance, Sold By Pro-Chem, Inc.;
(12) Ricmar Industries Tang-I-Cide Tangerine Fragrance Disinfectant, Sold Exclusively By Ricmar Industries, Inc.;
(13) Neutron NI-712 Disinfectant Spray, Stock #104787, A product of Neutron Industries,
c) ITW Dymon
Medaphene Plus Lemon Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal,
Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt. 16 oz (1 lb), 12 cans/
case, containing 0.19%
o-phenylphenol and 68.00% ethyl alcohol, Product #52820. The firm name on
the
label is ITW Dymon. The product is also distributed under the
following private labels:
(1) Renown Lemon
Disinfectant Deodorant,
Distributed by AmSan, LLC; Concept Lemon Scented Disinfectant
Deodorant, Product 5282057750, Sold By Manny's Sanitary Supplies, Inc.,
d) ITW Dymon Medaphene Plus Country Garden
Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal,
Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt
16-oz. (1-lb.), 12 cans/case, containing 0.19% o-phenylphenol and 68.00%
ethyl alcohol, Product #42620. The firm name on the label is ITW Dymon. The
product is also distributed under the following private labels:
(1) Area
Two-In-One Disinfectant Spray Country, Reorder #ADI-531, Sold By Area
Distributors, Inc.;
(2) Lawson Fresh Air Disinfectant Spray, Product 90386,
Manufactured for Lawson Products, Inc.;
(3) Major Envirocide Country Fresh Disinfectant Spray, Sold By Major Chemical Company;
(4) Concept Potpourri Disinfectant Deodorant, Sold By Manny's Sanitary Supplies, Inc.;
(5) Meyer Century Zip Hospital Disinfectant, A Product of Meyer Laboratory, Inc;
(6) Pro Chem Deocept Passion Hospital Disinfectant, Sold By Pro-Chem, Inc.;
(7) State Discover Aerosol Disinfectant Country Garden, Stock #109568 and and #109569, Sold By State Industrial Products;
(8) Sterling Quality Nature's Country Garden Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation;
(9) North Woods TB Plus Spray Disinfectant Spray, Sold By Superior Chemical Corp.;
(10) Renown Potpourri Disinfectant Deodorant, Product REN05056, Distributed by: AmSan, LLC;
(11) Asepsis Asepticide Disinfectant Spray, Handpiece Disinfectant, Country Garden, Distributed By Asepsis International, Inc.;
(12) Dazzle "D" Disinfectant Spray Country Garden, Sold By Henry Kraft Inc.;
(13) TB-Cide Country Garden Hospital Disinfectant, Sold By Industrial Distributors, Inc.;
(14) G-Sep Aromatic Disinfectant Spray, Sold By Moore Research, Inc;
(15) Mt. Hood Chemical Hospit-all New Country Garden Fragrance Disinfectant Spray, Sold By Mt. Hood Chemical Corp.;
(16) IDS Medi-Spray Country Garden Disinfectant Deodorant, Manufactured For Sold By International Distribution System, Inc.;
(17) Neutron Country Garden Disinfectant Spray, Stock #110030, A product of Nuetron Industries;
(18) Sunrise Environmental Scientific Disinfectant Spray Country Garden, Sold By Sunrise Environmental Scientific;
(19) United
Laboratories Flower Power Disinfectant Spray, United 135, Sold By United
Laboratories, Inc. One private label is packaged in a 16-oz. steel aerosol can,
Watkins Sanisol Disinfectant Spray, Product 42616, Manufactured for Watkins
Incorporated;
CODE
a) Initially recalled lot
numbers: ITW Dymon brand --A56241, A56242, and A87242; private labels -
A17241, A27241, A30141, A31141, A31142, A75241, A85241, A85244, A57241,
A57242, A87241, A95241, and A99041; Expanded recall lot numbers: ITW Dymon
brand --A84141, A84142, A18143, A98141, A09141, A09142, A80342, A90341,
A14342, A14343, A66341, and A66342; private labels - A91141, A91142, A23141,
A74141, A84141, A65141, A65142, A65143, A18141, A18142, A18143, A98141,
B89141, B89142, A60241, A80241, A80242, A21241, A91241, A91242, A85242,
A85243,
A49241, A59241, A59242, A70341, A80341, A80342, A61341, A71341,
A71342, A82341, A83341, A14341, A14342, A55341, A55342, A56341, A56342,
A66341, A70051, A01051, A81051, A13051, and A13052;
b) Initially recalled
lot numbers: ITW Dymon brand A66244 and A58241; private labels - A66241,
A66243, A66244, A87241, and A58241. Expanded recalled lot numbers: ITW Dymon
brand - A96141, A88241, A00341, A10341, A24342, A24343, A25341; private labels -
A81141, A81142, A91141, A91142, A02141, A02142, A23141, A94141, A65141, A28141,
A09141, A19141, A19142, A90241, A90242, A21241, A21242, A32241, A42241, A66242,
A88241, A00341, A61341, A42341, A72341, A24341, A24342, A25341, A56341, A01051,
A01052, A01053, A11051, A81051, A21051, A82051, A23051, and A23052;
c)
Initially recalled lot number: Private label - A66241, Expanded recalled lot
numbers: Private label - A23141
and A28141;
d) Initially recalled lot
numbers: ITW Dymon brand A66241 and A87241; private labels - A31141,
A74241, A75241, A75242, A56241, A66241, and A88241 Expanded recall lot
numbers: ITW Dymon brand - A04141, A04142, A14141, A09141, A91241, A02241,
A10341, A82341, A92341, A15341, A15342, and A25341; private label - A81141,
B42141, A23141, A23142, A23143, A04141, A84141, A95141, A96141, A96142, A18141,
A09141, A80241, A21241, A91241, A42241, A33241, A10341, A90341, C02341, A42341,
A42342, A24341, A34341, A34342, A15341, A55341, A70051, A71051, and
A12051
RECALLING FIRM/MANUFACTURER ITW Dymon, Olathe, KS,
REASON
Failed EPA required
efficacy testing; may not perform as intended.
VOLUME OF PRODUCT IN
COMMERCE 4,372/12-can cases
DISTRIBUTION Nationwide
PRODUCT
a) Brilliance CT System,
40 channel configuration using version 1.2 software,
b) Brilliance CT System, 16 Power configuration
using version
1.2 or 1.2.1 software,
c) Brilliance 16, 10, and 6
configuration (water cooled version) using 1.0. 1.1, 1.2,1.2.2, or 1.2.4
software,
d) Brilliance CT system, 16, 10, and 6 configuration (air cooled version) using version 1.2 or 1.2.1 software,
e) MX8000IDT CT Scanner using version 2.5.5,
3.0,
3.1, 3.2, 3.2.2, or 3.2.4 software,
\f) MX8000 Dual
v.EXP CT Scanner using version 2.5. software,
g)
Extended Brilliance Workspace using 1.x or 2.x software,
h) MxView using version 5.0, 5.0.1, or 4.1
software,
i) Gemini PET/CT system, Dual Configuration,
j) Gemini 16 PET/CT system, Slice Configuration,
CODE
All codes
RECALLING
FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc., Cleveland, OH
REASON
When two product applications called Flip and
Secondary Capture are used together, it is possible for image orientation labels
to be incorrect.
VOLUME OF PRODUCT IN COMMERCE 2,130
units
DISTRIBUTION Nationwide and Internationally
PRODUCT PTT-LA Lupus
anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL, Cat. No. 00599,
CODE
Lot Number 041755, exp.
06/06
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Diagnostica Stago, Inc., Parsippany, NJ,
Manufacturer: Diagnostica
Stago, Franconville, France.
REASON Variable clotting times
observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT
Reagent.
VOLUME OF PRODUCT IN COMMERCE 740
units
DISTRIBUTION Nationwide
PRODUCT C-Vision Angiographic
X-Ray System, Model IVS-100
CODE Software
versions before 3.0
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Shimadzu Medical Systems, Torrance, CA,
Manufacturer: Shimadzu Corporation, Kyoto, Japan.
REASON
Fluro exposure stuck open,
will not terminate.
VOLUME OF PRODUCT IN COMMERCE 24
units
DISTRIBUTION Nationwide and Canada
PRODUCT GE Healthcare Centricity
Cardiology A11000 Workstation
CODE Version 4.2.6
and version 4.2.7.05
RECALLING FIRM/MANUFACTURER
Recalling
Firm: GE Medical Systems Information Technologies, Mount Prospect, IL,
Manufacturer: Camtronics
Medical Systems, Ltd, Hartland, WI.
REASON The potential exists for the A11000 workstation to
mix images from one study with images from another study. Mixed studies could be
from the same patient or from different patients. Mixed patient images could
compromise patient condition or diagnosis and treatment.
VOLUME OF PRODUCT
IN COMMERCE 1,287 devices
DISTRIBUTION Nationwide and
Internationally
PRODUCT STA-R blood coagulation
analyzer. Catalog Number 57160,
CODE All units
distributed under Catalog Number 57160
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc.,
Parsippany, NY,
Manufacturer:
Diagnostica Stago, Franconville, France.
REASON Concerning the
STA-R blood coagulation analyzer,
there is a possible failure mode associated with patient samples receiving
prolonged exposure time to reagents during the cuvette roll change
process.
VOLUME OF PRODUCT IN COMMERCE 215
units
DISTRIBUTION Nationwide
PRODUCT BD Vacutainer Blood
Transfer Device. It consists of a Luer attached via a hub to a needle covered
with a sleeve, Catalog #364880,
CODE Lot
#5076799, Exp 2/2008; #50076797, exp. 2/2008; #5976798, Exp 2/2008; #5098260,
Exp 3/2008; #5112114, Exp 3/2008.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson &
Company, Franklin Lakes, NJ,
Manufacturer: Becton Dickinson Caribe Ltd, San Lorenzo,
PR.
REASON Customer complaints
state the needle had separated from the hub, resulting in blood exposure and/or
dislocation of the needle.
VOLUME OF PRODUCT IN COMMERCE 641,200
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Baxter Interlink
System Non-DEHP Y-Type Catheter Extension Set, product code 2N3371; An Rx
sterile,
nonpyrogenic fluid pathway, 5.7", 0.8 mL Vol., with 2 injection
sites and a male Luer Lock adapter;
b) Baxter
Minivolume Extension Set, 72", product code 2C5687; An Rx sterile,
nonpyrogenic fluid pathway,
72", 1.6 mL Vol., with a male Luer Lock adapter,
c) Baxter Minivolume Extension Set, 36", product code 2C5685; An Rx sterile, nonpyrogenic fluid pathway,
36", 0.9 mL Vol., with
a male Luer Lock adapter,
d) Baxter Mini-Infuser
Microbore Extension Set, product code 2C9201; An Rx sterile, nonpyrogenic
fluid pathway, 61", 0.5 mL Vol., with Luer Lock adapters,
e) Baxter Tamper Resistant Anti-Siphon PCA Extension Set,
60",
product code 2C9205; An Rx sterile, nonpyrogenic fluid pathway, 60", 1.2 mL
Vol., with Luer Lock adapters,
f) Baxter Tamper
Resistant Anti-Siphon PCA Extension Set, 96", product code 2C9206; An Rx
sterile, nonpyrogenic fluid pathway, 96", 1.6 mL Vol., with Luer Lock adapters,
g) Baxter Tamper Resistant Anti-Siphon
Combination Set, 101", product code 2L3507; An Rx sterile, nonpyrogenic fluid pathway, 101", 2.5 mL Vol., with male Luer Lock
adapter,
h) Baxter Extension Set, product code 2C9219; An Rx sterile,
nonpyrogenic fluid pathway, 61", 1.4 mL Vol.,
with Luer Lock adapters,
i) Baxter Interlink System Huber Needle Extension
Set, product code 2N3703; An Rx sterile, nonpyrogenic
fluid pathway with
Needle Gauge 22, Needle Length 3/4", Total Volume 0.40 mL, Total Length
9",
j) Baxter Interlink System Huber Needle Extension
Set, product code 2N3706; An Rx sterile, nonpyrogenic fluid pathway with
Interlink Y-Injection Site, Needle Gauge 19, Needle Length ¾", Total Volume
0.75 mL, Total Length 10",
k) Baxter Interlink System
Huber Needle Extension Set, product code 2N3707; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle
Length 3/4", Total Volume
0.75 mL, Total Length 10",
l) Baxter Interlink System Huber Needle Extension Set,
product
code 2N3709; An Rx sterile, nonpyrogenic
fluid pathway with Interlink
Y-Injection Site, Needle Gauge 22, Needle Length 3/4", Total Volume
0.75 mL, Total Length 10",
m) Baxter Interlink System Huber
Needle Extension Set, product code 2N3710; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle
Length 1", Total Volume
0.75 mL, Total Length 10",
n)
Baxter Interlink System Huber Needle Extension Set, product code 2N3712; An
Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length 1", Total Volume
0.75
mL, Total Length
10",
o) Baxter Interlink System Huber Needle Extension
Set, product code 2N3714; An Rx sterile, nonpyrogenic
fluid pathway with
Interlink Y-Injection Site, Needle Gauge 22, Needle Length 1", Total Volume
0.70 mL, Total Length 10",
p) Baxter Interlink System
Huber Needle Extension Set, product code 2N3716; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle
Length 1-1/2", Total
Volume 0.75 mL, Total Length 10",
CODE
a) Lot numbers UR247189, UR268656, UR268920,
UR270256;
b) Lot numbers UE107920, UE108480, UE108696, UE108704,
UE108977, UE108985;
c) Lot numbes UE107936, UE108019, UE108712, UE109140;
d) Lot number UR249987;
e) Lot number UR251058;
f) Lot
numbers UR254185, UR254524, UR273987;
g) Lot numbers UR251389, UR272328,
UR272781, UR274704;
h) Lot numbers UR266387, UR277061, UR277848;
i)
Lot numbers FC04055, FC05013;
j) Lot numbers FC04057, FC05001, FC05010, FC05017;
k) Lot numbers FC04053, FC05000, FC05005,
FC05012;
l)
Lot numbers FC04052, FC04058, FC04059, FC05006, FC05009;
m) Lot numbers
FC04050, FC05007, FC05014;
n) Lot numbers FC04054, FC05003, FC05021;
o)
Lot numbers FC04056, FC05004, FC05011;
p) Lot number FC05002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter
Healthcare, Corp., Round Lake, IL,
Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR.
REASON
The
extension sets contain microbore female luers that may crack during use,
resulting in leakage of medication or incomplete delivery of
medication.
VOLUME OF PRODUCT IN COMMERCE 208,306
sets
DISTRIBUTION Nationwide and Internationally.
PRODUCT Aqueduct Hematology
Workflow Manager, software, Part Number AQDCT,
CODE Not specified
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc.,
Brea, CA,
Manufacturer: Orchard
Software Corp, Carmel, IN.
REASON Potential for misidentification of historical
patient results within the Aqueduct Hematology Workflow Manager software. In
instances where the workflow manager software receives the same patient
identifier for more than one patient the Aqueduct Workflow Manager software
merges all results into one Patient File. This may cause test results to be
associated with the wrong patient.
VOLUME OF PRODUCT IN COMMERCE 36
units
DISTRIBUTION Nationwide.
PRODUCT
a) Guidant ENDOTAK SQ
Array models 0048, 0049, 0085. Subcutaneous Lead
Array.
Cardioversion/Defibrillation Lead.Sterilized with gaseous
ethylene oxide.
b) Guidant Lead Tunneler Kit model
6927. Accessory Kit for use with the Endotak SQ
Lead Array. Contains one
tunneler and four sheaths. Sterilized with gaseous ethylene oxide,
c) Oscor Introducer Kits Model LLP series.
Luer-Lock
Peel-Away Introducer Set. Each set contains: 1 peel-away sheath with built-in-luer-lock; 1 vessel dilator;
1-50-cm guidewire 1 18-G needle; 1
10-cc
syringe. Sterile EO. Models 6089, 6091, 6092, 6093, 6094, 6663 and
6664,
CODE
a) Serial numbers 200652 and
200655, Serial numbers 202864 thru 202900, Serial numbers 102087 thru
103287;
b) Lot number 104029 thru 105078;
c) Lot numbers C4-03103 thru
C4-03707; Lot numbers: C4-03601 thru C4-03691, Lot numbers: C4-03110 thru
C4-03684, Lot numbers: C4-03136 thru C4-03607, Lot numbers: C4-03501 thru
C4-03610,
Lot numbers: C4-03055 thru C4-03741, Lot numbers: C4-03280 thru
C4-03445
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Guidant Corporation, Saint Paul, MN,
Manufacturer: B. Braun Medical, Inc, Cherry Hill, NJ.
REASON
A manufacturer for Guidant
Introducers has received reports of introducer sheaths with cracked hubs/handles
and/or improper peeling of the sheath during use.
VOLUME OF PRODUCT IN
COMMERCE 870 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Alsius CoolGard 3000
Temperature Regulation System
b) Alsius CoolGard
3000 Temperature Regulation System
CODE All units manufactured before April 12,
2005
RECALLING FIRM/MANUFACTURER Alsius Corporation, Irvine, CA
REASON
Firm wants users to be aware not to leave the units
in standby mode for more than an hour in rooms in excess of 75 F due to risk of
an alarm mode being generated due to overheating.
VOLUME OF PRODUCT IN
COMMERCE 207 Units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Abbott TestPack + Plus
hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG
(Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes
CODE
Lot 17297M200, exp. 10/25/05
RECALLING
FIRM Abbott Laboratories MPG, Abbott Park, IL
REASON False Positive results may
be obtained with the identified lot of list 3A60-16 when using a negative
patient sample or a negative control.
VOLUME OF PRODUCT IN
COMMERCE 3,049 kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT Abbott Clinical
Chemistry Bilirubin Calibrator, List # 1E66-03
CODE Lot #20881M100
RECALLING
FIRM/MANUFACTURER Abbott Laboratories Diagnostic Div., South Pasadena, CA
REASON The value sheet for the Clinical Chemistry Bilirubin
Calibrator, lot #20881M100 calibrator value sheet, has the calibrator values
transposed for the Total Bilirubin Assay LN 7D60, Total Bilirubin Assay LN 8G62,
and Neonatal Bilirubin Assay LN 9D88.
VOLUME OF PRODUCT IN
COMMERCE 836 units
DISTRIBUTION Nationwide and
Internationally
WEEK ENDING SEPTEMBER 17
PRODUCT
a) Bac T/ALERT’ 3D Control Module,
b) Bac T/ALERT’ 3D
Combination Module,
c) Bac T/ALERT’ 3D 60,
CODE All Models
RECALLING
FIRM/MANUFACTURER Biomerieux, Inc, Durham, NC
REASON A Bac T/ALERT 3D system
failed to detect a positive sample in a pediatric Bac T/ALERT PF
bottle.
VOLUME OF PRODUCT IN COMMERCE 2,745
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Biomet Vanguard
microplasty slidex femoral 4-in-1 block, 57.5 mm, stainless steel; Ref.
32-485101
b) Biomet Vanguard microplasty slidex
femoral 4-in-1 block, 60 mm, stainless steel; Ref. 32-485102
c) Biomet Vanguard microplasty slidex femoral
4-in-1 block,
62.5 mm, stainless steel; Ref. 32-485103
d) Biomet
Vanguard microplasty slidex femoral 4-in-1 block, 80 mm, stainless steel; Ref.
32-485108
e) Biomet Ascent SI knee instruments
sliding femoral 4-in-1 block, x-small, stainless steel; Ref. RD140629, f) Biomet Ascent SI knee instruments sliding femoral
4-in-1 block, small, stainless steel; Ref. RD140630
g) Biomet Ascent SI knee instruments sliding femoral
4-in-1
block, medium, stainless steel; Ref. RD140631, h)
Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, large,
stainless steel; Ref. RD140632,
i) Biomet Ascent SI
knee instruments sliding femoral 4-in-1 block, x-large, stainless steel; Ref. RD140633,
j) Biomet Maxim SI knee instruments
sliding femoral 4-in-1 block 55 mm, stainless steel; Ref. RD140529,
k) Biomet Maxim SI knee instruments sliding femoral 4-in-1 block, 60 mm, stainless steel;
Ref. RD140530,
CODE
a) Lots 193410, 244080, 341450, 335660, 775440,
775480, 624750 and 987550;
b) Lots 800030, 107960, 150150, 244090,
341470, 340460, 110160, 089070, 150560, 246460, 246470, 281680, 128100,
281670, 281690, 289650, 299480, 302850, 480060, 480070, 480080, 333930,
490710, 490720, 521300, 571400, 208950, 059810, 208940, 471980, 667580,
649910, 822020, 851780, 939010, 952030, 710250, 783350, 858300 and
104360;
c) Lots 834410, 199180, 200390, 341490, 341480, 351390, 302860,
302870, 302880, 302890, 302900, 302910, 353490, 480090, 480120, 480100,
490730, 480110, 353970, 353980, 490740, 333940, 383660, 477620, 521410,
571420, 059820, 667590, 667600, 208960, 471990, 851770, 886160, 897780,
561320, 710300, 783390 and 973480;
d) Lots 244100, 351430, 521170,
521090, 521160 and 911330;
e) Lots 147360, 201140, 310920, 238700,
238710, 397060, 467290, 481540, 523300, 607880, 024490, 560790 and
761870;
f) Lots 074170, 117920, 117580, 170730, 191880, 232930, 439220,
409710, 441190, 468560, 523310, 608390, 602560, 024500, 278400 and
840090;
g) Lots 061800, 300150, 191900, 192030, 542470, 439240, 443030,
481530, 608400, 024540, 278410 and 761860;
h) Lots 061810, 217860,
170830, 195550, 467300, 481550, 450420, 602570, 608410, 576640, 024590, 388080 and 840080;
i) Lots 117650, 170870, 229660, 238680, 467310,
491720, 608420, 542570, 491721, 024600, 351170 and 561190;
j) Lots
140370, 007450, 165140, 104620 and 458200;
k) Lots 692030, 847270, 893240,
991260, 103470, 103440, 136560, 271330, 170710, 356500, 399630, 399640,
564090, 712190, 744790, 757850, 770410, 994540 and 863650
RECALLING
FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN
REASON The instrument may have
been assembled improperly, which may result in reversed resection cuts on the
femur and affect implant performance, resulting in the need for revision
surgery.
VOLUME OF PRODUCT IN COMMERCE 1,993
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Boston Scientific brand
Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400,
catalog number 26-240
CODE Lots 7575613,
7583594, 7715339 and 7730068
RECALLING FIRM/MANUFACTURER Boston
Scientific Corp., Spencer, IN
REASON The distal tip may dislodge from the
device during use and the firm has received complaints of electrical
errors.
VOLUME OF PRODUCT IN COMMERCE 115
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Pioneer Surgical brand
Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP
CODE Lots 306456, 306457, 306613, 306712, 306713, 306714,
306816, 306817, 306818, 306819, 306820, 306821, 306822, 307526, 307527, 307528,
307667, 307668, 308510, 308938, 310662, 310663, 310664, 310665, 311718, 312169,
519935 and 521042
RECALLING FIRM/MANUFACTURER Pioneer Surgical
Technology, Marquette, MI
REASON The product has a higher than normal locking
torque, which may cause the saddle to malfunction or to break intraoperatively.
VOLUME OF PRODUCT IN COMMERCE
5,069
units
DISTRIBUTION Nationwide
PRODUCT Oxacillin Screen Agar,
Catalog 221952, in disposable plastic media plates, packaged in boxes of 10
plates/box
CODE Lot #5140549, Exp
8/17/05
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Becton-Dickinson & Co., Sparks, MD,
Manufacturer: Becton-Dickinson Diagnostics, Madison, WI.
REASON
Microbiological media for
antibiotic susceptibility testing gives false test results.
VOLUME OF
PRODUCT IN COMMERCE 20,930 agar
plates
DISTRIBUTION Nationwide and Internationally
PRODUCT VITROS Chemistry GENT
Reagent REF 680 1711, *** Each box contains 6 packs. Each pack contains liquid
reagent for 50 tests.
CODE 01-5846, Exp. 31 May
2006; 01-6036 Exp 31 October 2006; 01-6239 Exp 31 January 2007
RECALLING
FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester, NY
REASON
Negatively biased results can be observed when the
reagent pack has less than 12 tests remaining and has been on the analyzer
greater than 24 hours.
VOLUME OF PRODUCT IN COMMERCE 443
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Magnetom Avanto.
Magnetic Resonance Imaging System. Model number 7391167,
b) Magnetom Espree. Magnetic Resonance Imaging System.
Model
number 10018165,
CODE
a) Serial numbers 25007 to
25557;
b) Serial numbers 30001 to 30075
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions
USA, Inc., Malvern, PA,
Manufacturer: Siemens Medical Solutions,
Erlangen,
Germany.
REASON There is a
misalignment of the patient table that may occur between the patient table and
the opening to the magnet bore. As a result, there may be gaps between the
patient table and the magnet cover. If this occurs, there is an increased risk
that fingers or other body parts may become caught in the gap when moving the
patient table.
VOLUME OF PRODUCT IN COMMERCE 209
units
DISTRIBUTION Nationwide
PRODUCT Clinac (linear
accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac),
CODE
Affected Serial Numbers: H140001, H140002,
H140003, H140004, H140005, H140006, H140007, H140009, H140022, H140010, H14001,
H140012, H140013, H140014, H140015, H140016, H140017, H140018, H140019, H140021,
H140023, H140024, H140025
RECALLING FIRM/MANUFACTURER Varian
Medical Systems, Inc., Palo Alto, CA
REASON Emergency Off Switch located
on the device may not function correctly resulting in the device remaining
powered on after the switch is activated.
VOLUME OF PRODUCT IN
COMMERCE 24 units
DISTRIBUTION Nationwide, Denmark, Hong
Kong, and Japan
PRODUCT TM-300 Traction System;
an Rx software driven device used for patient traction, Product No. A501-009,
CODE
Serial numbers 1000 through
1207
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Sammons Preston Rolyan, Bolingbrook, IL,
Manufacturer: ITO Co., Ltd,
Inashiki-gun, Japan.
REASON The traction device may
malfunction, producing oscillation and a jerking motion.
VOLUME OF PRODUCT
IN COMMERCE 208 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT E-Z-EM brand, Basic
biopsy tray, catalog no. 4125.
CODE Lot number
0324 on the package. The correct lot number is 0424.
RECALLING
FIRM/MANUFACTURER North Coast Medi-Tek, Inc., Mentor, OH
REASON Product
contains the incorrect lot number.
VOLUME OF PRODUCT IN
COMMERCE 350 devices
DISTRIBUTION NY
WEEK ENDING SEPTEMBER 30
PRODUCT
a) Baxter Colleague
Single Channel Volumetric Infusion Pumps; Made in Singapore; product codes
2M8151,
2M8151R, 2M8161, 2M8161R,
b) Baxter Colleague
Triple Channel Volumetric Infusion Pumps; Made in Singapore; product codes
2M8153,
2M8153R, 2M8163, 2M8163R,
CODE
a)
All serial numbers below 13120001CS, All serial numbers below 13110181CC;
b) All serial numbers below 13120001CT, All serial numbers below
13110338TC
RECALLING FIRM/MANUFACTURER Baxter Healthcare
Corporation, Round Lake, IL
REASON Swelling of the sealed lead-acid
batteries in the infusion pump can cause internal pump damage, and excessive
battery discharge can damage the batteries if the pump is left on battery power
for an extended period of time after the Battery Depleted alarm
occurs.
VOLUME OF PRODUCT IN COMMERCE 253,185 pumps
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Product is an
Orthopedic device contained in a Peel Foil Pouch. Product is labeled in
part:
"REF C6121 QTY 1 3.5mm Bio-Anchor with Disposable Driver, STERILE",
b) Product is an Orthopedic device contained in a Peel
Foil Pouch. Product is labeled in part: "REF C6121H
QTY 1 3.5 x 10.5 mm
Bio-Anchor with Disposable Driver, Preloaded with One #2 Herculine Suture,
STERILE",
c) Product is an Orthopedic device
contained in a Peel Foil Pouch. Product is labeled in part: REF C6120A
QTY 1 BIO-ANCHOR, PRE-LOADED 3.5mm x 10.5 mm, Sterile,
d) Product is an Orthopedic device contained in a Peel
Foil
Pouch. Product is labeled in part: REF, QTY 1,
Hornet Disposable Inserter,
BioStinger Implant, STERILE,
e) Product is an
Orthopedic device contained in a Peel Foil Pouch. Product is labeled in
part: REF, QTY 1
BioScrew XtraLok, STERILE,
CODE
a) Lot number's: BBB34096, BBB35001, BBB38590,
BBB47862, BBB56209, BBB59492, BBB61957, BBB63207, BBB66991, BBB69760,
BBB70775;
b) Lot number's: BBB65719, BBB67474, BBB68490;
c) Lot number's:
BBB31322, BBB33118, BBB35867, BBB36669, BBB37705, BBB39726, BBB40462,
BBB45116, BBB46067, BBB46733, BBB52902, BBB55911, BBB57543, BBB59489,
BBB61937, BBB63968, BBB66392, BBB67468;
d) Lot number's: BBB32927, BBB33173,
BBB34093, BBB40588, BBB41400, BBB43500, BBB44122, BBB47021, BBB51947,
BBB54961, BBB61003, BBB63978, BBB67469, BBB71590, BBB32928, BBB33170,
BBB33172, BBB34090, BBB35000, BBB37713, BBB40589, BBB41401, BBB42354,
BBB43059, BBB45125, BBB47861, BBB48837, BBB49882, BBB50769, BBB57155,
BBB57550, BBB61002, BBB62845, BBB66407, BBB68489, BBB33174, BBB36672,
BBB50768,
BBB62844, BBB69766;
e) Lot number's: BBB32078, BBB34094,
BBB34999, BBB35880, BBB38626, BBB48838, BBB49880, BBB59210, BBB53860,
BBB55923, BBB59491, BBB65474, BBB66408, BBB68488, BBB31428, BBB34095, BBB35002,
BBB36673, BBB48839, BBB51999, BBB55022, BBB59493, BBB66410, BBB35055, BBB50780,
BBB61023, BBB34089, BBB35879, BBB37714, BBB48840, BBB52911, BBB55921, BBB65475,
BBB30602, BBB31323, BBB49881, BBB52912, BBB67472, BBB52000
RECALLING
FIRM/MANUFACTURER Linvatec Corp, Largo, FL
REASON There is a
possibility that the pouch Tyvek header to foil longitudinal seal was not
properly sealed, prior to sterilization. Therefore there is a potential for
compromised sterility of the devices.
VOLUME OF PRODUCT IN
COMMERCE 9,967 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Baxter Flo-Gard 6201
Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished), 2M8063G
(global), 2M8063U, 2M8063F, 2M8063A, 2M8063D & 2M8063B,
b) Baxter Flo-Gard 6301 Dual Channel Volumetric
Infusion Pump,
catalog #2M8064, 2M8064R (refurbished), 2M8064G, 2M8064U, 2M8064F, 2M8064A,
2M8064D &
2M8064B,
CODE All serial
numbers
RECALLING FIRM/MANUFACTURER
Recalling firm: Baxter
Healthcare Corporation, Round Lake, IL,
Manufacturer: Baxter Healthcare Corporation, Singapore,
Singapore.
REASON The mounting
screws of the pole clamp may come loose, allowing the pole clamp assembly to
detach from the rear pump housing, if they are not maintained on at least an
annual basis.
VOLUME OF PRODUCT IN COMMERCE 188,000 units
DISTRIBUTION Nationwide and Internationally
PRODUCT The TRIO
Spondylolisthesis Reduction Instrument is a Manual Surgical Instrument unique to
the implantation of Stryker Spine TRIO PS this instrument is intended for use in
the reduction of degenerative Spondylolisthesis. Catalog No: 48905110,
CODE
Lot Code: 039524; 039981; 045152; 045153; 045154;
045155; 045156; 045157; 045158; 045159; 048721; 048722
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics
Corp, Mahwah, NJ,
Manufacturer: Stryker
Spine, Cestas, France.
REASON The
threaded part of the instrument may break when connected to the screw and
potentially result in an adverse health consequence.
VOLUME OF PRODUCT IN
COMMERCE 107 Instruments
DISTRIBUTION Nationwide
PRODUCT Clinitron At Home Air
Fluidized Therapy Bed,
CODE Serial numbers:
CS102304, CS103257, CS103901, CS103902, CS103903, CS103904, CS103909, CS103911,
CS103914, CS103915, CS103916, CS103917, CS103919, CS103921, CS103923, CS103924,
CS103925, CS103928, CS103932, CS103933
RECALLING
FIRM/MANUFACTURER Hill-Rom Manufacturing, Inc, Charleston, SC
REASON
Sudden
unexpected lowering of the head of the bed may occur due to failure of the head
of the bed actuator.
VOLUME OF PRODUCT IN COMMERCE 21 beds
DISTRIBUTION AL, FL, KY, LA, MA, NC, NY, TN, TX, and VA
PRODUCT Product is a Powerflex P3
Dilation Catheter,
CODE Lot numbers R0305581,
R0305159, R0305284, R0305286, R0305155 and R0305104.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Cordis Corporation, Miami Lakes,
FL,
Manufacturer: Cordis Europa N.V.,
Roden, Netherlands.
REASON During
competitive product testing, wire movement difficulties were observed in
Powerflex P3 units. Due to the possibility of user inconvenience, Cordis is
recalling the six affected lots of Powerflex P3. There is no patient
impact.
VOLUME OF PRODUCT IN COMMERCE 100 units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) BD DTX Plus, 60"
complete single-line pressure monitoring kit, Part Number 682000,
b) BD DTX Plus, 60" complete dual-line pressure
monitoring
kit, Part Number 682007,
c) BD DTX Plus, 72" complete
single-line pressure monitoring kit, Part number 682014,
d) BD DTX Plus, Stand-alone pressure transducer
with 3cc/hr
flush device, Part number 682018,
e) BD DTX Plus, 12"
single-line neonatal pressure monitoring kit. Part number 682040,
f) BD DTX Plus, Custom single-line neonatal pressure
monitoring kit, Part number 687104,
g) BD DTX Plus,
Custom single-line pressure monitoting kit.Part number 687196,
h) BD DTX Plus, Custom triple-line pressure monitoring kit.
Part number 687206,
i) BD DTX Plus, Custom dual-line
pressure monitoring kit. Part number 687341,
CODE
a) Lot Numbers: 407104, 407387;
b) Lot Number
407467;
c) Lot number 407026;
d) Lot number 407109;
e) Lot numbers
407033, 408053;
f) Lot Number 408038;
g) Lot number 410174;
h) Lot
numbers: 411062, 411539, 501148;
i) Lot Numbers: 410177, 411063,
411540
RECALLING FIRM/MANUFACTURER
Recalling Firm: BD
Medical Systems, Sandy, UT, by telephone and fax on July 1,
2005.
Manufacturer: BD Critical Care Systems, Singapore, Singapore.
Firm initiated recall is ongoing.
REASON Actuating tab may detach
from the stopcock body, allowing fluid leak.
VOLUME OF PRODUCT IN
COMMERCE 7,839 units
DISTRIBUTION Nationwide, Guam and
Japan
PRODUCT Encore Reverse Shoulder
Prosthesis (RSP),
CODE Catalog number:
506-00-006, lot numbers: 260212, 260222, and 244642; Catalog number: 506-00-007,
lot number: 250272; Catalog number: 506-00-008, lot numbers: 260242, 254342,
260252, 244662, and 244312; Catalog number: 507-06-175, lot numbers: 261832,
244732, 967721, and 006192; Catalog number: 507-08-175, lot numbers: 261842,
241392, 872681, and 872671
RECALLING FIRM/MANUFACTURER Encore
Medical Lp, Austin, TX,
REASON Incorrect alignment markings or no markings at all
on a reverse shoulder prosthesis unit.
VOLUME OF PRODUCT IN
COMMERCE 93 primary stems; 56 revision
stems
DISTRIBUTION MA, MD, OK, TX, FL, SC, CA, MT, CO, SD, and
NM
PRODUCT Panorama Patient
Monitoring Network, Cardiac Arrhythmia Monitor. Part Number 0040-00-0366-20,
CODE
Version 8.02
RECALLING
FIRM/MANUFACTURER Datascope Corp, Mahwah, NJ
REASON The software version
contains an anomaly which could freeze the unit when the right click button is
used on the mouse.
VOLUME OF PRODUCT IN COMMERCE 115
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Ultrasound probe cover,
sterile. Catalog No. 910811,
CODE Lot number:
0520, expiration date: 1-10
RECALLING FIRM/MANUFACTURER North Coast
Medi-Tek Inc., Mentor, OH
REASON Unsealed packages.
VOLUME OF PRODUCT IN
COMMERCE 300 units
DISTRIBUTION OH
PRODUCT Enpath Steerable Sheath,
model 10775-003, Sterile EO. Single Use Only. The Enpath Deflectable Catheter is
a flexible tipped percutaneous catheter designed for gaining access to the
peripheral and coronary systems. The device features adjustable tip geometry
through use of a sliding mechanism with locking feature to deflect the catheter.
There are two versions of the tool: one with a luer fitting for Tuohy-Borst
valve connection, the other with a hemostasis valve and a sideport infusion
line. The kit includes a flexible catheter dilator to facilitate deflectable
catheter passage.
CODE W34968 and
W35440
RECALLING FIRM/MANUFACTURER Enpath Medical, Inc., Plymouth, MN
REASON
Enpath has become aware that some of the Enpath
Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves
in that the valve can leak or the valve was observed to have a small
hole.
VOLUME OF PRODUCT IN COMMERCE 140
units
DISTRIBUTION MA
PRODUCT Medtronic Midas Rex
Classic, GS and Legend dissecting tools, Rx only, Single Use Only,
CODE
All lot numbers
RECALLING
FIRM/MANUFACTURER Power Surgical Solutions, Fort Worth, TX
REASON Potential compromise of sterile packaging for
disposable dissecting tools.
VOLUME OF PRODUCT IN
COMMERCE 3,522,710 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Lasik Custom Pak
containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S,
PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2
3/4. All contents considered sterile unless package is opened or damaged.RX
Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in
the firm's Alcon Custom Pak Part Number 10162-01 under the description of dual
tip irrigator, 8 ports, 16G.),
CODE Lot numbers:
520522H, 511655H, and 489635H
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Alcon Research, Ltd, Fort Worth,
TX,
Manufacturer: Alcon Laboratories,
Inc., Houston, TX.
REASON Unknown
residue noted on surface of flap irrigators incorporated into custom paks.
VOLUME OF PRODUCT IN COMMERCE
75
units
DISTRIBUTION LA
PRODUCT Bard Davol Reliavac® 400
Closed Wound Suction Kit, Sterile/EO * Single use * Medium-Large 3/16" (15 Fr.,
4.7mm) O.D. PVC Drain * 12.5" (31.7cm) Hole Pattern, X-ray Opaque Stripe
Attached Trocar * 400cc Evacuator ** Y-Connecting Tube. The product contains a
400cc Evacuator, Y-connector with drainage tube and a 3/116 PVC drain with
trocar. These components are provided together in a kit but not pre-assembled.
Catalog Number: 0034630,
CODE Lot Number:
NGPE0150
RECALLING FIRM/MANUFACTURER
Recalling Firm: C.R.
Bard Inc., Urological Division, Covington, GA,
Manufacturer: Bard Sdn
Bhd, Nogales Sonora, Mexico.
REASON An incorrect Y-connector was
placed in the kit.
VOLUME OF PRODUCT IN COMMERCE 360
units
DISTRIBUTION AL, CA, FL, GA, IL, IN, NJ, TN, TX, Belgium and
Japan
PRODUCT SourceOne Healthcare
Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07,
packaged as 10 trays per case.
CODE Lot number
0503, expiration date 11-07.
RECALLING FIRM/MANUFACTURER North
Coast Medi-Tek, Inc., Mentor, OH
REASON Outside box labeling,
containing 10 trays, incorrectly identified the product as ultrasound trays.
Product is Breast Biopsy trays, Cat. 255826R2. Individual tray package labeling
correctly identifies the product as Breast Biopsy tray.
VOLUME OF PRODUCT
IN COMMERCE 50 kits, packaged as 10 kits per each of 5
boxes
DISTRIBUTION OH