SEPTEMBER 2006
WEEK ENDING SEPTEMBER 9
PRODUCT
a) Guidant INSIGNIA I
Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294,
1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the
following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model
1466, 1494). The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers
from Guidant. The NEXUS I Entra pacemakers are multiprogrammable pacemakers from
Intermedics. The family consists of both dual-chamber and single-chamber models,
offering adaptive-rate therapy and providing various levels of therapeutic and
diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate models
have an accelerometer, which is a motion sensor that responds to patient
activity. Sterilized with gaseous ethylene oxide,
b)
Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR
(models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of
pacemakers includes the following: SR (model 1390) and DR (model 1490,
1491). The Intermedics NEXUS I Ultra (models 1390, 1490, 1491) are not
available in the US. The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable
pacemakers from Intermedics. The family consists of both dual-chamber and
single-chamber models, offering adaptive-rate therapy and providing various
levels of therapeutic and diagnostic functionality. These pacemakers include
ventricular Automatic Capture which automatically measures the ventricular
pacing threshold and adjusts the pacing output to 0.5 V above the measured
threshold. Two sensors are available: these adapt the pacing rate to the
patient's changing metabolic demand. Minute ventilation responds to changes
in respiration, and the accelerometer responds to patient activity (motion).
INSIGNIA and NEXUS I Ultra models can use either the accelerometer or minute
ventilation
sensor, or a blend of both accelerometer and minute ventilation.
Sterilized with gaseous ethylene oxide.
c) Guidant
INSIGNIA I Plus family of pacemakers includes the following: SR (models1194);
and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers
includes the following: DR (model 1467, 1468). The INSIGNIA I Plus
pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Plus
pacemakers are multiprogrammable pacemakers from Intermedics. The
family consists of both dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of therapeutic and
diagnostic functionality. Two sensors are available: these adapt the pacing
rate to the patient's changing metabolic demand. Minute ventilation responds
to changes in respiration, and the accelerometer responds to patient
activity (motion). INSIGNIA and NEXUS I Plus models can use either the
accelerometer or minute ventilation sensor, or a blend of both accelerometer and
minute ventilation. Sterilized with gaseous ethylene oxide,
d) Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI
(model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model
1292). Intermedics NEXUS I AVT family of pacemakers includes the following:
VDD (model 1428), DDD (model 1432), SR (model 1392) and DR (model 1492). The
INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant. The
NEXUS I AVT pacemakers are multiprogrammable pacemakers from Intermedics.
The family consists of both
dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of therapeutic and
diagnostic functionality. These pacemakers include ventricular Automatic Capture
which automatically measures the ventricular pacing threshold and adjusts
the pacing output to 0.5 V above the measured threshold. The INSIGNIA and
NEXUS I Plus adaptive-rate models have an accelerometer, which is a motion
sensor that responds to patient activity. Sterilized with gaseous ethylene
oxide. ****The following devices are not available in the US,
e) Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model
1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber,
Sterilized with gaseous ethylene oxide. Implantable cardioverter
defibrillators (ICDs) are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia
therapy. Therapies include both low- and high-energy shocks using either a
biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate
features, is available to detect and treat bradyarrhythmias and to support
the cardiac rhythm after defibrillation therapy. VENAK PRIZM 2 devices offer
dual-chamber bradycardia features (atrial and /or ventricular pacing and
sensing), and VENTAK PRIZM 2 VR devices offer single-chamber bradycardia
features (ventricular pacing and sensing),
f) CONTAK
RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145).
CONTAK RENEWAL TR2 devices are not available in the US. The devices are
designed to provide cardiac resynchronization therapy by providing biventricular
electrical stimulation to synchronize the right and left ventricular
contractions. The device also provides adaptive-rate bradycardia therapy.
The pulse generator has independent, programmable outputs for the atrium,
right ventricle and left ventricle,
g) VITALITY
(models 1870, 1871, T125, T127, T135) and VITALITY 2 (models T165, T167, T175, T177). Implantable Cardioverter Defibrillators
(ICD), are designed to
detect and terminate ventricular tachycardia (VT) and ventricular
fibrillation (VF) and provide
bradycardia therapy (atrial and ventricular
pacing). Therapies include both low- and
high-energy shocks using either a
biphasic or monophasic waveform. Vitality 2 devices
also offer a wide
variety of antitachycardia pacing schemes to terminate slower, more
stable
ventricular tachyarrhythmias. Bradycardia pacing, including adaptive-rate
features, is available to detect and treat bradyarrhythmias and to support
the cardiac
rhythm after defibrillation therapy. Devices denoted with DR
offer dual-chamber
bradycardia features (atrial and/or ventricular pacing
and sensing), and the devices
denoted with VR offer single-chamber
bradycardia features (ventricular pacing and
sensing),
CODE Affected serial numbers will be listed on Guidant's
website beginning 07/10/2006, at www.guidant.com. On the home page click on the
''Communications Providing Important Safety Information'' link found in the
''Product Safety Information for Physicians'' box. Then click on ''Device Lookup
/ Search''.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant
Corporation, Saint Paul MN,
Manufacturer Firm:
Guidant-Ireland, Clomel, Ireland.
REASON Guidant has determined that low-voltage capacitors
from a single component supplier may malfunction in a manner that can lead to
premature battery depletion or loss of pacing output without warning in the
affected devices.
VOLUME OF PRODUCT IN COMMERCE 49,779
devices
DISTRIBUTION Nationwide and Canada
PRODUCT ADVIA 2120 systems --Automated Complete Blood Cell and Differential Cell Counter,
CODE
ADVIA 2120 Part No. 067-A012-01 (without Autosampler) and Part No. 067-A011-02 (with
Autosampler); all ADVIA 2120 systems
using Version 5 system software including Version 5.0.6 (Part No. 067-S045-06,
English version), Version 5.1.1 (Part No. 067-S058-01, English version), and
Version 5.2.7 (Part No. 067-S045-15, English version).
RECALLING
FIRM/MANUFACTURER Bayer Healthcare, LLC (Diagnostics Division), TarrytownNY,
REASON
The ADVIA 2120 has reported ; highly intermittent
low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin
(HGB) and Platelets (PLT) and an abnormal baso cytogram.
VOLUME OF PRODUCT IN COMMERCE
318
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
TC
Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous
Oxygen Monitor),
CODE Model
#TCM4
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer
America Inc, Westlake OH,
Manufacturer Firm:
Radiometer Medical ApS, Bronshoj, Denmark.
REASON Alarm may be silenced- Rapid switching, on and
off, of the TCM4 monitor may cause the built-in acoustical alarm to remain
silent when tripped.
VOLUME OF PRODUCT IN COMMERCE 9
monitors
DISTRIBUTION Nationwide
PRODUCT
a) BioGenex brand
Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R
and PU082-UP,
b) BioGenex brand Hepatitis B Virus Surface Antigen
Antibody, Cat. No. AM364-5M
and MU364-UC,
CODE
a) Lot Numbers: AR0820904, PU0820204, PU0820305,
PU0820803F, PU0820804;
b) Lot Numbers: AM3640305, AM3640404, AM3640406,
AM3640505, AM3640804,
AM3640804X, MU3640305, MU3640504, MU3641004,
MU3641005
RECALLING FIRM/MANUFACTURER Biogenex Laboratories, San Ramon
CA
REASON Misbranding-The product labeling (label and insert) is
misbranded in that the product does not comply with the labeling requirements
for an Analyte Specific Reagent (ASR).
VOLUME OF PRODUCT IN
COMMERCE 96 units
DISTRIBUTION Nationwide
PRODUCT UniCel DxC
600/600PRO/600i/800/800PRO Synchron Clinical Systems, Part Numbers:
A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software
version 1.4,
CODE Software version 1.0, Software
version 1.2, Software version 1.4
RECALLING
FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA,
REASON Incorrect
Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to
the UniCel DxC System, the Reagent Status screen will incorrectly show 'Days
Left' as 21. The correct Reagent Status for a new Lithium reagent cartridge is
14 days. Lithium reagent used past 14 days may produce low quality control
and/or patient results.
VOLUME OF PRODUCT IN COMMERCE 524
units
DISTRIBUTION Nationwide and Canada
PRODUCT Staclot LA 20 tests,
Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay,
CODE
Lot 050947D --exp. April 2007; Lot 051527A
-- exp. June 2007; Lot 051527B -- exp. June 2007; Lot 051527C -- exp. June 2007;
Lot 051527D -- exp. June 2007.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc., Parsippany NJ,
Manufacturer:
Diagnostica Stago, Franconville,
France.
REASON Decrease in
sensitivity; This could result in a false negative result for patients with weak
to moderate lupus anticoagulants.
VOLUME OF PRODUCT IN
COMMERCE 3,167 units
DISTRIBUTION Nationwide
PRODUCT SafeClinitubes, Capillary
caps (purple), 905-787. The defective capillary caps may be included in
capillary tube kits as follows: Clinitubes Kits: 942-890 (D941P-240-85x1), Lot
Code: R0048; Clinitubes Kits: 942-892 (D957P-70-100x1), Lot Codes: R0045 through
R0050; Clinitubes Kits: 942-893 (D957P-70-125x1), Lot Codes: R0058 through
R0063; Clinitubes Kits: 942-898 (D957P-70-70x1), Lot Code: R0019. Each of the
kits listed above contains one (1) bag of Capillary Caps, 905-787,
CODE
Lot #0605068 or Lot #0605069.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc,
Westlake OH,
Manufacturer: Radiometer Medical ApS, Bronshoj,
Denmark.
REASON Leaking Capillary
Caps- The dimensions and shapes of the capillary caps do not fit the capillary
tubes correctly. This can cause the capillary tubes to leak.
VOLUME OF
PRODUCT IN COMMERCE 940
DISTRIBUTION Nationwide
PRODUCT safePICO Samplers,
self-filling arterial blood samplers. The syringe blood samplers are
individually packed in plastic pouches and distributed in cartons. Each carton
contains ten (10) boxes and each box contains 100 pouches. The product subject
to recall is identified with the following Part Numbers/Order No: 956-610,
956-612, 956-614, 956-616, and 956-623,
CODE The
recalled product is identified with the following Part Numbers; Lot Numbers; and
Expiration Dates: Part #956-610, Lot #RD-28, and Expiration Date: 2008-01; Part
#956-612, Lot #RJ-05, and Expiration Date: 2008-02; Part #956-614, Lot #RL-30,
Expiration Date: 2008-03, Part #956-616, Lot #RQ-02, Expiration Date: 2008-04;
and Part #956-623, Lot Code: RL22, and Expiration Date: 2008-03
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc, Westlake
OH,
Manufacturer: Radiometer Medical ApS, Bronshoj,
Denmark.
REASON Leaking Tip
Caps- Tip caps may leak; after air has been expelled from the syringe through
the vented safe tip caps.
VOLUME OF PRODUCT IN COMMERCE 252
DISTRIBUTION Nationwide
PRODUCT Delphi IVantage
Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and
12864051DEL, Rev. 8,
CODE All serial
numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Delphi Medical
Systems, Troy MI,
Manufacturer: Delphi Medical
Systems Colorado Operations, Longmont Co.
REASON Potential for under-infusion without alarm;
Cassette rollers stop moving , but the pump shaft continues rotating without
alarm.
VOLUME OF PRODUCT IN COMMERCE 169
units
DISTRIBUTION FL and Internationally
PRODUCT BD Unopette -- System
Tests (Erythrocyte Fragility Test Kit). Catalog # 365830,
CODE Lot numbers: 5014328. Exp. June 2006; 5159075, Exp.
July 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton
Dickinson & Co., Franklin Lakes, NJ,
Manufacturer: Becton Dickinson
Caribe, Ltd., San Lorenzo, PR. F
REASON Formulation problems. Lower pH
of the solutions may increase Red Blood Cell hemolysis.
VOLUME OF PRODUCT
IN COMMERCE 6,340 kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) ADVIA 1650 Chemistry
System, Automated Clinical Chemistry Analyzer --
human serum, plasma and
urine tests,
b) ADVIA 1200 Chemistry System, Automated
Clinical Chemistry Analyzer --
human serum, plasma and urine tests,
c) ADVIA 2400 Chemistry System, Automated Clinical Chemistry
Analyzer --
human serum, plasma and urine tests,
CODE
Code Information: Part No. 073-A001; all Advia
Chemistry System units and serial numbers are involved in this "field
correction" as well as existing assay lots for CARB, PHNY, GENT and DIG;
Code
Information: Part No. 094-A001; all Advia Chemistry System units and serial
numbers are involved in this "field correction" as well as existing assay lots
for CARB, PHNY, GENT and DIG.
Code Information: Part No. 073-A010; all Advia
Chemistry System units are serial numbers are involved in this "field
correction" as well as existing assay lots for CARB, PHNY, GENT and
DIG.
RECALLING FIRM/MANUFACTURER Bayer Healthcare, LLC (Diagnostics
Division), Tarrytown NY,
REASON Low QC recovery observed
on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay
or - Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result
is artificially low (as much as --25%). PHNY was determined to also exhibit a
similar carryover effect on CARB. All others were found not to produce the same
reagent probe-based carryover effect.
VOLUME OF PRODUCT IN
COMMERCE 1,138 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Product Description:
Liquid AutoHDL Cholesterol Reagent Set, Catalog Nos. HH945-240, HH945-480,
H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct determination of high density lipoprotein
(HDL) cholesterol in
serum or plasma,
b) AutoHDL Cholesterol Reagent Set for
the quantitative determination of high density lipoprotein (HDL) cholesterol
in serum or plasma, Imported and Marketed in India; Catalogs HH7545-80,
c) AutoHDL Cholesterol R1 Reagent Set, a homogeneous
method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Catalogs HH445-R1,
d) AutoHDL Cholesterol R2 Reagent Set, a homogeneous method
for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Catalogs HH445-R2,
e) Auto HDL reagent, sold by Pointe Scientific; Catalog no.
3-H7545-L, f) Auto HDL Cholesterol reagent in
bottles of 320 ml and 1000 ml, Catalog nos. 7-H7545-320 and 7-H7545-1000,
CODE
Lots 523002, exp. 2/07, and 531801, exp.
2/07
RECALLING FIRM/MANUFACTURER Pointe Scientific, Inc., Canton, MI
REASON
Unexpected changes in QC and proficiency results
due to QC and proficiency material matrix.
VOLUME OF PRODUCT IN
COMMERCE 90 L of R1 and 30 L of R2
DISTRIBUTION Nationwide
and Internationally
PRODUCT
a) RapidLab® 1200
Systems, Model 1245-Blood gases, electrolyte and
blood pH test system, Part
No. 05061537,
b) RapidLab® 1200 Systems, Model 1265-
Blood gases, electrolyte and
blood pH test system, Part No. 05063769;
CODE
All units using Version 1.0, 1.01, or 1.02
software connected to LIS, Rapidlink®, or Rapidcomm(tm) data management
systems.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Healthcare, LLC
(Diagnostics Division), Tarrytown NY,
Manufacturer: Bayer Healthcare, LLC Diagnostics Division,
Norwood MA.
REASON Invalid CO-oximeter
values; Bayer HealthCare determined that under very specific conditions, the
RapidLab® 1245 or RapidLab® 1265 systems may report invalid CO-oximeter values
to an LIS, Rapidlink®, or Rapidcomm(tm) data management system.
VOLUME OF
PRODUCT IN COMMERCE 488 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Roche/Hitachi K
Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747,
902, 911, 912, 917, Modular and Cobas c 501 clinical chemistry analyzers; Roche
Catalog/Part Number 10825441001/US #722-4402,
CODE Lots: 190, 193 and 195
RECALLING
FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN
REASON
Expired product (dated 2006.06) was shipped as
replacement for recalled product.
VOLUME OF PRODUCT IN COMMERCE 137
electrodes
DISTRIBUTION Nationwide
WEEK
ENDING SEPTEMBER 16
PRODUCT Bausch & Lomb * ReNu®
with MoistureLoc®, Multi-purpose soft contact lens solution * Sterile,
CODE
All lots, all sizes
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb, Rochester, NY
Manufacturer: Bausch & Lomb, Greenville, SC.
REASON
Reports of Fusarium Infections among
contact lens wearers
VOLUME OF PRODUCT IN COMMERCE 3 million
bottles
DISTRIBUTION Nationwide and Internationally
PRODUCT D826 Accessory kit for
single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor). Model #D826, Part Number: 904-308,
CODE
Lot Codes R0172 through R0223, inclusive, Expiration
Date: Year-month listed on label.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc.,
Westlake, OH,
Manufacturer: Radiometer
Medical ApS, Bronshoj, Denmark.
REASON Excessive Drift-the membrane units of the device cause the
electrode to exceed performance standards for drift in the first two or more
calibrations
VOLUME OF PRODUCT IN
COMMERCE 4517
DISTRIBUTION Nationwide and
Internationally
PRODUCT FP1000 Cell Preparation
System Part Number 624922,
CODE Software Version
1.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman
Coulter Inc., Brea, CA,
Manufacturer:
Beckman Coulter, Inc., Miami, FL.
REASON During the cleaning cycle performed during the shutdown
procedure of the Beckman Coulter FP1000 Cell Preparation System, fluid (diluted
bleach) may drip from the probe in the location of the back reagent rack
potentially resulting in bleach and/or water dripping into the reagents
contaminating them and resulting in possible incorrect results.
VOLUME OF
PRODUCT IN COMMERCE 11 units
DISTRIBUTION Nationwide and
Canada
PRODUCT
a) Zimmer VERSYS Hip
System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper,
collarless, size 14, 135 mm stem length, tivanium Tl-6AL-4V alloy, sterile, w/calcicoat ceramic coating; Cat. no. 65-7861-14-04
(65786101404),
b) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced
taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium
TI-6AL-4V alloy, sterile; Cat. no. 7861-14-04 (00786101404),
c) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced
taper, 12/14 neck taper, collarless, size 15, 140 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-15-04 (00786101504),
d) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced
taper, 12/14 neck taper, collarless, size 17, 150 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-17-04 (00786101704),
e) Zimmer Trabecular metal primary hip prosthesis femoral stem,
press-fit, collarless, 12/14 neck taper - standard body -extended neck
offset, size 14, 149 mm stem length, sterile, tivanium TI-6AL-4V
alloy/tantalum,
sterile; Cat. no. 00-7864-014-20 (00786401420),
f) Zimmer Trabecular metal primary hip prosthesis femoral stem,
press-fit, collarless, 12/14 neck taper - standard body -extended neck
offset, size 15, 160 mm stem length, sterile, tivanium TI-6AL-4V
alloy/tantalum,
sterile; Cat. no. 00-7864-015-20 (00786401520),
g) Zimmer Trabecular metal primary hip prosthesis femoral stem,
press-fit, collarless, 12/14 neck taper - standard body -standard neck
offset, size 16, 171 mm stem length, sterile, tivanium TI-6AL-4V
alloy/tantalum, sterile; Ref. no. 00-7864-016-00 (Cat. no. 00786401600),
h) Zimmer MAYO Conservative hip prosthesis femoral stem,
porous, 12/14 neck taper, large+, tivanium TI-6AL-4V alloy, sterile; REF. 8026-13-05 (Cat. no. 00802601305),
i) Zimmer
MAYO Conservative hip prosthesis femoral stem, porous,
12/14 neck taper,
extra large, tivanium TI-6AL-4V alloy, sterile, REF. 8026-14 (Cat. no.
00802601400),
j) Zimmer ZMR Hip System femoral body,
revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset,
spout body, size D, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF.
9990-20-46
(Cat. no. 00999002046),
k) Zimmer ZMR Hip
System femoral body, revision, nitrided, porous, 12/14 neck taper, extended,
46 mm neck offset, cone body, size C, 55 mm build-up, tivanium TI-6AL-4V
alloy, sterile; REF. 9993-19-55
(Cat. no. 00999301955),
l) Zimmer ZMR Hip System femoral body, revision,
nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size C,
35 mm
build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-35
(Cat. no.
00999601935),
m) Zimmer ZMR Hip System femoral body,
revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset,
cone body, size C, 45 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF.
9996-19-45
(Cat. no. 00999601945),
n) Zimmer ZMR Hip
System femoral body, revision, nitrided, porous, 12/14 neck taper, standard,
40 mm neck offset, cone body, size F, 35 mm build-up, tivanium TI-6AL-4V
alloy, sterile; REF. 9996-23-35
(Cat. no. 00999602335),
CODE
a) Lot 60460460;
b) Lots 60454196, 60454197,
60454198, 60454199, 60465016 and 60465017;
c) Lots 60454201, 60454202,
60454203, 60454204, 60465019 and 60469053;
d) Lots 60454205, 60454206 and
60465024;
e) Lots 60465254 and 60469823;
f) Lots 60454312 and
60461052;
g) Lots 60454306 and 60465367;
h) Lots 60450985 and
60450986;
i) Lot 60460474;
j) Lot 60465192;
k) Lot 60465195;
l) Lot
60454259;
m) Lot 60451050;
n) Lot 60460936
RECALLING
FIRM/MANUFACTURER Zimmer Inc., Warsaw, IN
REASON Lack of assurance
of proper metal fatigue strength due to a metal grain structure
anomaly.
VOLUME OF PRODUCT IN COMMERCE 181
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Cordis Neurovascular
Pre-Shaped PROWLER Infusion Catheters,
b) Cordis
Neurovascular Pre-Shaped Prowler Select Infusion Catheters,
CODE
a) All lot numbers equal to or lower than: CAT
606051FX - LOT 13084977;
CAT 606051JX - LOT 13077739; CAT 606051MX - LOT
13100828;
CAT 606151FX - LOT 13095822; CAT 606151JX - LOT 13090978;
CAT
606151MX - LOT 13090976; CAT 6062310F - LOT 13090973;
CAT 6062310J - LOT
13090974; CAT 6062310M - LOT 13082015;
CAT 6062510FX - LOT 13075472; CAT
6062510JX - LOT 13090975;
CAT 6062510MX - LOT 13082020; CAT 6062511FX - LOT
13090979;
CAT 6062511JX - LOT 13090971; CAT 6062511MX - LOT 13090972;
b)
All lot numbers equal to or lower than: CAT 606S152FX - LOT 13009595;
CAT
606S152JX - LOT 13010913; CAT 606S152MX - LOT 13009596;
CAT 606S155FX - LOT
13082017; CAT 606S155JX - LOT 13078245;
CAT 606S155MX - LOT 13082016; CAT
606S252FX - LOT 13064387;
CAT 606S252JX - LOT 13071036; CAT 606S252MX - LOT
13090990;
CAT 606S255FX - LOT 13084973; CAT 606S255JX - LOT 13084974;
CAT
606S255MX - LOT 13064409
RECALLING FIRM/MANUFACTURER Cordis
Neurovascular, Inc., Miami Lakes, FL,
REASON Sterility (package integrity)
compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that
some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped
PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch,
which may result in a compromise of the sterility inside the pouch.
VOLUME
OF PRODUCT IN COMMERCE 60,613 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Kuschall's K3/K4 Series
of Manual Wheelchair, Model Airlite,
CODE 0805007204, 0805040231,0805087799, 0805191275,
0805238718, 0805528869, 0805590456, 0805007205, 0805040233, 0805094654,
0805202392, 0805260264, 0805528870, 0805590458, 0805007206, 0805046010,
0805112919, 0805202409, 0805260267, 0805528879, 0805598707, 0805007207,
0805052515, 0805112920, 0805202410, 0805265355, 0805538825, 0805606638,
0805031769, 0805052531, 0805112921, 0805208212, 0805265356, 0805547691,
0805606639, 0805032072, 0805052780, 0805142288, 0805214576, 0805488915,
0805556308, 0805606650, 0805032078, 0805059713, 0805148474, 0805220731,
0805528850, 0805556313, 0805626956, 0805032082, 0805059770, 0805171786,
0805220813, 0805528852, 0805573454, 0805636805 0805032091, 0805081690,
0805171787, 0805226782, 0805528854, 0805573455, 0805636810, 0805040230,
0805087792, 0805178698, 0805226965, 0805528856, 0805590391, 0805643631,
0805643632, 0805743810, 0805793490, 0805837237, 0805871475, 0805937131,
0806309254, 0805664651, 0805743813, 0805802652, 0805845927, 0805894716,
0805969761, 0806309260 0805671759, 0805771388, 0805802878, 0805845935,
0805894890, 0805977531, 0806309261, 0805685506, 0805776512, 0805807275,
0805850343, 0805894892, 0806273105, 0806309267, 0805702791, 0805776514,
0805807278, 0805855553, 0805900539, 0806281922, 0806315127, 0805710093,
0805780848, 0805807281, 0805860047, 0805900540, 0806281924, 0806315184
0805710275, 0805784712, 0805811158, 0805865040, 0805906053, 0806303957,
0806320300, 0805716215, 0805784713, 0805815571, 0805865041, 0805922688,
0806303963, 0806326394, 0805721816, 0805784714, 0805815575, 0805871470,
0805929066, 0806303965, 0806326395, 0805738220, 0805789076, 0805815809,
0805871471, 0805937122, 0806309167, 0806338838, 0806338840, 0806372582,
0806390080, 0806415186, 0806448589, 0805771388, 0806338842, 0806372583,
0806390081, 0806415385, 0806448735, 0806350846, 0806372585, 0806390082,
0806422077, 0806455546 0806350855, 0806372614, 0806390083, 0806428328,
0806463285, 0806355566, 0806372615, 0806396466, 0806428330, 0806463289,
0806366353, 0806372616, 0806408921, 0806428344, 0806463290, 0806366354,
0806372618, 0806408928, 0806428346, 0806480052, 0806366356, 0806372620,
0806408929, 0806428563, 0806480055, 0806366544, 0806390074, 0806408930,
0806435361, 0806480070, 0806372581, 0806390075, 0806408938, 0806441968,
0806488512
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Invacare Corporation, ElyriaOH,
Manufacturer: Kuschall Ag,
Witteswil, Switzerland.
REASON If the user has chosen to
install optional anti-tippers on the chair, the anti-tipper as designed may not
be able to bear the stress of repeated or quick loads placed on it, causing the
bolt to bend or break.
VOLUME OF PRODUCT IN COMMERCE 211
wheelchairs
DISTRIBUTION Nationwide and Canada
PRODUCT BHI Agar with
Vancomycin,
for in vitro diagnostic use. Catalog # G14,
CODE Lot # 06136
RECALLING
FIRM/MANUFACTURER Hardy Media Inc Dba Hardy Diag, Santa Maria CA,
REASON
This recall is being conducted due to the
performance failure nearing the end of the product shelf life.
VOLUME OF
PRODUCT IN COMMERCE 860 Plates
DISTRIBUTION Nationwide and
PR
PRODUCT 7F Freezor Cardiac
Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.
CODE Lot number 00418
RECALLING
FIRM/MANUFACTURER CryoCath Technologies Inc., Kirkland, Canada,
REASON
Outer
cartons of catheters were mislabeled with two different reference numbers. The
front of the package showed the correct reference number; 207F1, however the
section on the top of the box incorrectly referenced 207F3. All inside labels
(inside the box and affixed on device pouches) showed the correct reference
number, 207F1
VOLUME OF PRODUCT IN COMMERCE 34
units
DISTRIBUTION Nationwide
PRODUCT TCM4 Series Monitoring
System (Base Unit) Model: 391-876 (affected device), transcutaneous oxygen
monitor; Compact Flash cards - Model #: 914-698 (Defective Device Component),
CODE
Lot Numbers R0036 thru R0043
(inclusive)
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Radiometer America Inc., Westlake, OH,
Manufacturer: Radiometer Medical
ApS, Akandevej 21,Bronshoj,
Denmark.
REASON System shut
down-When the TCM Monitor is turned on and the booting process begins, the
device stops after the memory count and will not proceed further.
VOLUME
OF PRODUCT IN COMMERCE 158 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT S1730 Calibration
Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used
with ABL700 Series Blood Gas Analyzers. Part #944-025,
CODE Lot QR-02, Expiration Date: September
2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer
America Inc., Westlake, OH,
Manufacturer: Radiometer Medical ApS,
Bronshoj, Denmark.
REASON Calibration solution for
ABL700 Blood Gas Analyzers is labeled with an incorrect bar code. The bar code
identified on the Cal Solution 2 product is actually the bar code for the rinse
solution.
VOLUME OF PRODUCT IN COMMERCE 638/200 ml
bottles
DISTRIBUTION Nationwide
PRODUCT Regius Model 370 Digital
Radiography Konica Minolta,
CODE Serial #
0729-0005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Konica
Minolta Medical Imaging USA, Inc., Wayne, NJ,
Manufacturer: Konica Minolta Medical & Graphic, Inc., Tokyo,
Japan.
REASON A hand grip
column, even though locked in position, moved downward about 3 cm while a
patient was holding the hand grip for lateral exposure. When the hand grip moved
down, the patient who was holding it lost his or her balance and almost fell.
This problem only occurred in Japan with one system.
VOLUME OF PRODUCT IN
COMMERCE One
DISTRIBUTION TX
WEEK
ENDING SEPTEMBER 23
PRODUCT Disetronic D-TRONplus
Insulin Pump Battery Pack; Ref/Catalog no. 04697014001
CODE Lots 06010107, 06030242, 06040085, 06050110 and
06060126
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Disetronic Medical System, Fishers, IN
Manufacturer: Disetronic Medical Systems AG,
Burgdorf,
Switzerland.
REASON The battery
may turn the pump off without warning due to a design change in the
battery.
VOLUME OF PRODUCT IN COMMERCE 6,604 packs
DISTRIBUTION Nationwide and Canada
PRODUCT
a) Medtronic Intrathecal
Catheter, Model 8731, (part of infusion systems using Medtronic implantable
pumps) The catheter is designed for use in the intrathecal space,
b) Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598,
(provides replacement parts for the distal section of the 8731 Intrathecal Catheter),
CODE
a) Model 8731
Base Lot Numbers: B011311N, B011421N, B011422N, B011500N, B011721N,
B011737N, B011738N, B011786N, N0012097, N0012140, N0012141, N0012521,
N0012692, N0012814, N0012815, N0012816, N0013149, N0013150,
N0013352,
N0013353, N0013354, N0013355, N0013707, N0013710, N0013936, N0014007,
N0014236, N0014237, N0014330, N0014331, N0014332, N0014722, N0015050. *Model 8731 Catheters and model 8598 Distal Revision kits
have a Base
Lot number of eight (8) characters plus a two (2) digit suffix that
represents serialization within these recalled lots. This list provides just
the Base lot Number (the first eight characters of the product Lot No. found
on the product labeling);
b) Model 8598 Base Lot Numbers: B011468N,
B011893N, B011894N, N0012129, N0012612, N0012969, N0012970, N0012971,
N0014057, N0014058, N0014179, N0014180, N0016472. *Model 8731 Catheters and
model 8598 Distal Revision kits have a Base Lot number of eight (8)
characters plus a two (2) digit suffix that represents serialization within these recalled lots. This list provides just the Base lot Number
(the
first eight characters of the product Lot No. found on the product
labeling)
RECALLING FIRM/MANUFACTURER Medtronic Neurological,
Minneapolis,MN, REASON Tip dislodgement during implantation-Medtronic is
recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter
Distal Revision Kit because the platinum-iridium tip may be dislodged by the
guide wire during implantation.
VOLUME OF PRODUCT IN COMMERCE 934
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Alaris® SE Pump (formerly
Signature Edition® Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131,
7132, 7200, 7201, 7230, 7231, and 7232, CODE All Lots. The serial numbers are not
sequential.
RECALLING FIRM/MANUFACTURER Cardinal Health 303 Inc DBA
Alaris Products, San Diego, CA
REASON This recall was initiated because of a
potential for over infusion with all models of the Alaris® SE Pumps (formerly
the Signature Edition® Infusion Pumps) caused by key bounce.
VOLUME OF
PRODUCT IN COMMERCE 147,461
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) BD Vacutainer Blood
Collection Assembly with BD Blunt Plastic Cannula; Catalog #303380,
b) BD Vacutainer Luer Adapter; Catalog #367290 and #367300,
c) BD Direct Draw Adapters, Catalog Number 364896,
CODE
a) Lot numbers: 5326641; 5336280;
5340618; 5341943; 5342548; 5342549; 5348212; 5348215; 5355629; 5357860;
5357891; 6009122; 6020878; 6024334; 6031704; 6040224;
b) Lot Number
5305585; Lot Numbers 5307894; 5307896; 5307900;
c) Lot Numbers 5311376,
5312193, 5312201
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Becton Dickinson & Company, Franklin Lakes NJ,
Manufacturer: BD Preanalytical Solutions,
Sumter,SC.
REASON Firm received complaints
indicating failure of the Non-Patient (NP) sleeve to function properly. This
sleeve covers the cannula and prevents leakage during blood
collection.
VOLUME OF PRODUCT IN COMMERCE 4,786,350
units
DISTRIBUTION Nationwide and Internationally
PRODUCT IntelliVue
MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient
monitoring system. Model: M3001A
CODE M3001A
options A01, A01C06, A01C12, and A01C18 with serial number prefix DE512 and MMS
software revision C.0 or B.1 M3001A options A02, A02C06, and A02C18 with serial
number prefix DE441 and DE512 and MMS software revision C.0 or
B.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips
Medical Systems, Andover MA,
Manufacturer: Philips Medizin Systeme Boblingen
Gmbh, Boblingen,
Federal Republic of Germany.
REASON Patient monitor may display inaccurate reading when the Disposable Sp02
Sensor is not attached
VOLUME OF PRODUCT IN COMMERCE 55,901
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) dideco Preassembled
Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C
b) dideco Preassembled Surgical Wash Set, Electa Essential ,
Cobe part numbers WS55E, WS125E, WS175E, WS225E,
c) Cobe STAT PAC, Autotransfusion Set (Made with Compact
Wash
Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C
d) Cobe STAT PAC Autotransfusion Set (made with Electa
Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17,
CODE
a) Lot
numbers: 0604030062, 0605310137,
Lot Numbers: 0602170043, 0603030050,
0603170057, 0603270019, 0604210104, 0605310135, 0606200074,
0606280029,
Lot Numbers: 0602100031, 0602170037, 0602240025, 0603030052, 0603100018, 0603270020, 0604070034, 0604130049, 0605030155,
0606200075,
0607200058;
b) Lot numbers: 0603030047, 0604030059, 0605170017,
Lot
Numbers: 0602170041, 0603030051, 0604210103,
Lot Numbers: 0601180099,
0604030060,
Lot Numbers: 0601180100, 0602170042, 0603030049,
0603170058, 0604030061, 0604070035, 0604130050, 0605230075, 0607200059;
c)
Lot numbers: 0611600045, 0615000020, 0616400010, 0617800124, 0618600111,
0619200113, 0620600004,
Lot Numbers: 0611600044, 0615000019, 0616400009, 0619200112, 0620600003, 0621300089,
Lot Numbers: 0615700004, 0618600106,
0621300091,
Lot Numbers: 0614300112, 0617100072, 0617800125, 0619200114,
0620600005,
Lot Numbers: 0611600046, 0613000074, 0613600144, 0615000021,
0615700003, 0617100073, 0617800126, 0619200115, 0619900050,
0620600006;
d) Lot numbers: 0610100225, 0613000077, 0615700007,
0618600109, 0621300094, Lot Numbers: 0608000247, 0610800007, 0612300036, 0613000076, 0613600146, 0615700006, 0617200003, 0617800128,
0619200116,
0619900053, 0621300093,
Lot Numbers: 0617200004, 0619900054, 0621300095,
Lot Numbers: 0611600047, 0612300034, 0613000075, 0614300116, 0617200002, 0617800127, 0618600107, 0621300092,
Lot Numbers: 0612300035, 0615000022, 0616400011,0618600108, 0619900052,
Lot Numbers: 0616400012, 0618600110,
Lot Numbers: 0609400006, 0610100223, 0615700005, 0619900051,
Lot Numbers:
0613600145, 0616400013, 0617200005, 0619900055
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Cobe Cardiovascular, Inc,
Arvada, CO,
Manufacturer:
Sorin Group Italia Srl, Mirandola Modena, Italy.
REASON Foreign particles-manufacturing error may lead to
abrasion of bowl seal in blood recovery sets, possibly causing particles in the
blood.
VOLUME OF PRODUCT IN COMMERCE 8,964 wash sets, 1,518 Stat
pacs
DISTRIBUTION Nationwide
PRODUCT
a) CORDIS SV-5 Steerable
Guidewire, 180 cm., 5 Steerable Guidewires, ENDOVASCULAR, Catalog # 503558,
b) CORDIS-SV-5 Steerable
Guidewire, 300 cm.,5 Steerable Guidewires,
Cordis a Johnson Johnson Company ,ENDOVASCULAR,
Catalog #
503558X,
c) CORDIS SV-8 Steerable Guidewire, 180 cm, 5
Steerable Guidewires,
ENDOVASCULAR, Catalog # 503658,
d) CORDIS SV-8 Steerable
Guidewire, 300 cm., 5 Steerable Guidewires,
ENDOVASCULAR, Catalog # 503658X,
CODE
a) Lots: 70206754 70206755 70206760 70306717
70306718 70306754 70306771
70306791 70306821 70306848 70406714 70406739
70406767 70506775;
b) 70905743 70905744 70905745 70206756 70206758 70206759
70306719
70306720 70306792 70306822 70306849 70406715 70406768 70406796
70506745 70506753 70506754 70506755;
c) 70306850 70406741 70406797
70506746;
d) 70306851 70406742 70406769 70506720 70506777
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Cordis Corporation, Miami Lakes,
FL,
Manufacturer: Lake Region Mfg Co, Inc, ChaskaMN.
REASON
Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for
guidewire fracture resulting in tip separation.
VOLUME OF PRODUCT IN
COMMERCE 14,788 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Skytron General
Purpose Surgical Table; Model 6600,
b) Skytron General
Purpose Surgical Table, battery model; Model 6600B,
CODE
a) All units. Serial numbers 6600-2D-001 through
6600-2L-102;
b) All units. Serial numbers 6600B-2D-002 through
6600B-2L-060
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Skytron, Div. The KMW Group, Inc, Grand Rapids, MI,
Manufacturer: Mizuho Medical Co, Ltd., Tokyo, Japan.
REASON
The release levers can
inadvertently release under load while the leg section is positioned at a ninety
degree angle causing the leg section to drop.
VOLUME OF PRODUCT IN
COMMERCE 160 tables
DISTRIBUTION Nationwide
PRODUCT Greiner bio-one,
Vacuette® Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black
ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 *
B050609 * 2007-05 * Sterile *,
CODE Item
#454332, Lot #B050609
RECALLING FIRM/MANUFACTURER Greiner Bio-One
North America, Inc., Monroe, NC
REASON Coagulation tubes found with no
additive.
VOLUME OF PRODUCT IN COMMERCE 160 cases (192,000
pieces)
DISTRIBUTION Nationwide
PRODUCT Boston Scientific
vanSonnenberg Sump with 'J' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess
and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No.
20-201,
CODE Lot 8606405; exp. March 31,
2009
RECALLING FIRM/MANUFACTURER Boston Scientific Corp, Spencer, IN
REASON Lack of assurance of sterility, as the sterile barrier is
weak and may be damaged on one edge.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION TX
PRODUCT
a) Neoligaments Staple
Impactor, 6 mm Staple Impactor: 202-3001,
b)
Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010,
CODE N/A
RECALLING FIRM/MANUFACTURER
Xiros Plc, Leeds, United Kingdom
REASON The impactors are being
recalled for modification so that they can be disassembled fully for cleaning
and sterilization, on suspicion that the assembled items retain contamination
after cleaning and may not be effectively sterilized by the recommended hospital
sterilization cycles.
VOLUME OF PRODUCT IN
COMMERCE 99
DISTRIBUTION Nationwide and
Internationally
PRODUCT LIFEPAK 20
external defibrillator/monitor
CODE LP 20
domestic serial numbers 34107307, 33911492, 33946302, 33894355, 33933894,
33951494, 33980272, 33986554, 33924702, 33881437, 33905482, 33894423, 33951266,
33905466, 33955767, 33971830, 34022189, 34071195, 34107256, 33900980, 33971829,
33980275, 33980280, 33980281, 33980287, 34017814, 34107419, 34071134, 33986933,
33947927, 34071165, 33967385, 34066585, 34071189, 34011819, 34011822, 33894426,
33894572, 33900981, 33936889, 34054495, 34060183, 33938363, 33959538, 33981789,
33981792, 33981793, 33981794, 33981795, 33981796, 33981797, 33981799, 33981805,
34071237, 34011821, 33894425, 33922299, 33938921, 33938924, 33959550, 33930122,
33933904, 34107178, 33955760, 33897337, 33955747, 33894255, 33951295, 33951456,
33976455, 33951447, 33894406, 33951275, 33933878, 33946268, 33946277, 33976406,
33976407, 33976408, 33976410, 33976411, 33976412, 33976413, 33976414, 33976415,
33976416, 33976417, 33976418, 33976419, 33976420, 33976424, 33976426, 33976427,
33976428, 33976429, 33976430, 33976431, 33979469, 33979470, 33979471, 33979472,
33979473, 33979474, 33905581, 33905585, 33905590, 33905609, 33905621, 33905622,
33911446, 33911449, 33911450, 33911470, 33911477, 33911528, 33911571, 33897320,
33897322, 33897329, 33897342, 33905514, 33905518, 33911627, 33955832, 33951484,
33951605, 33955759, 33955765, 34017742, 34107418, 33951059, 33951467, 34017810,
34022168, 34022175, 34022176, 33951473, 33951487, 34017813, 33955761, 33894580,
33992539, 33905444, 33971948, 33950588, 33951128, 33951273, 33951287, 33951434,
33951551, 33915884, 33915964, 33922357, 34066561, 33911587, 33971953, 33986931,
33997554, 33955806, 33955833, 34003587, 34003615, 34011698, 34011712, 34022213,
33947935, 33967345, 33967356, 33967367, 33967382, 33967402, 33967413, 33971817,
33971825, 33971832, 33971853, 33971860, 33971898, 33980313, 33981782, 33981787,
33986322, 30568540, 33951292, 33951293, 33951403, 33951409, 33951462, 33951468,
33951497, 33951518, 33951535, 33951552, 33951553, 33951560, 33951569, 33951576,
33951580, 33951582, 33951583, 33951585, 33951586, 33951588, 33951589, 33951592,
33951593, 33951595, 33951597, 33951598, 33951599, 33951600, 33951601, 33951604,
33955748, 33955751, 33955752, 33959570, 33992551, 33992569, 34022195, 34052650,
34052661, 34052662, 34052673, 34052685, 34052686, 34054508, 34060208, 34060827,
34060849, 34063588, 34063590, 34063596, 34063600, 34063602, 34063603, 34063604,
34063605, 34063606, 34063607, 34063608, 34063615, 34063619, 34066562, 34066573,
34066574, 34066576, 34066581, 34066584, 34066587, 34107052, 34107058, 34107059,
34107118, 34107165, 34107170, 34107171, 32601734, 33894320, 33946296, 34011706,
33997567, 33901753, 33901761, 33901762, 33901770, 33901771, 33901773, 33901777,
33901782, 33901787, 33904876, 33904910, 33904913, 33904914, 33904917, 33904921,
33904922, 33904923, 33904926, 33904928, 33904929, 33904931, 33904932, 33904933,
33904936, 33904937, 33904938, 33905427, 33905430, 33905432, 33905434, 33905440,
33905441, 33905443, 33905451, 33905470, 33905473, 33905474, 33905488, 33967403,
33981780, 33911601, 33915910, 33915916, 33915917, 33915961, 33959578, 33894289,
33897319, 33905507, 33905516, 33905520, 33905521, 33911611, 33911614, 33911624,
33911631, 33911632, 33911634, 33911635, 33917440, 33917443, 33917444, 33917447,
33917448, 33917452, 33917453, 33917454, 33917455, 33917456, 33917457, 33917461,
33917463, 33917464, 33917465, 33917466, 33917467, 33917468, 33917470, 33921045,
33921046, 33921047, 33921049, 33921050, 33921052, 33921053, 33921055, 33922294,
33959606, 33951603, 33955750, 33955762, 33955771, 34107379, 34071180, 34071197,
34107378, 34107380, 34107411, 34107426, 34107438, 33986324, 33986555, 33979488,
33980264, 33981778, 33986878, 33986897, 33904924, 33905459, 33905495, 33905496,
33905497, 33905587, 33911468, 33933906, 33901735, 31491390, 33894413, 33938926,
33951405, 33951426, 33951596, 33955802, 33955803, 33955827, 33955829, 33955831,
33955839, 33924675, 33924679, 33947909, 33986550, 33986566, 33986915, 33986917,
33986920, 33986921, 33986922, 33986923, 33986924, 33986925, 33990262, 33990270,
34015700, 33997552, 33901737, 33904878, 33905438, 33986873, 33986877, 34071213,
33924704, 33950587, 33951283, 33951298, 34107265, 34017808, 33976463, 33980266,
33980278, 33980279, 33980285, 33980290, 33980291, 33980294, 33980301, 33980304,
33911597, 33911602, 33911603, 33915887, 33915888, 33915889, 33915890, 33915892,
33915893, 33915894, 33915895, 33915897, 33915898, 33915899, 33915908, 33915911,
33915912, 33915914, 33915919, 33915922, 33915925, 33915928, 33915929, 33915930,
33915931, 33936874, 33936877, 33947249, 33947264, 33947931, 33976446, 33976447,
33976456, 33976468, 33976470, 33976471, 33976477, 33976478, 33976479, 34011825,
34017783, 33971838, 33971901, 33971905, 33971910, 33980268, 33980300, 33986330,
33986338, 33986342, 33986344, 33986345, 33986348, 33986349, 33986351, 33986543,
33986561, 33986562, 33986563, 33986564, 33986565, 34017806, 33897344, 33897350,
34063598, 34063616, 33990265, 34015699, 34071185, 34071171, 34054499, 33986913,
34071193, 33911532, 33911535, 33936914, 33980311, 33981772, 33990276, 33971950,
33894290, 33911625, 34071214, 33986323, 33986549, 33986551, 33986559, 34071202,
34071190, 34022185, 34066483, 34107401, 34071233, 33911554, 33911595, 33915885,
33933909, 33951449, 33951602, 33986840, 34107157, 34066570, 33986325, 33986339,
33986553, 33986556, 33986558, 33951439, 33951556, 33951568, 33951572, 33980297,
33897327, 33980274, 33915956, 33951476, 34071212, 33905589, 33905592, 31388033,
34071209, 32659831, 33933911, 33990271, 34011832, 33905582, 33894597, 33955840,
33915926, 33915939, 34071178, 33933931, 33924682, 33924699, 33924703, 33924706,
33930102, 33997573, 33924684, 33924692, 33924695, 33924696, 33924697, 33924701,
33924705, 33930103, 33930105, 33930107, 33946303, 33946314, 33980308, 33981781,
33997566, 33897353, 33936850, 33947897, 33947915, 33947942, 33971845, 33955755,
33986911, 34011824, 34017741, 34017744, 33915896, 33980296, 33986334, 33986335,
33986337, 33986343, 33986546, 33898437, 33898439, 33951475, 33951517, 33980298,
33915962, 33901774, 33971913, 33971926, 33986879, 33986880, 33986894, 33911512,
33986871, 33936879, 33951430, 34052669, 33955775, 34063572, 34066583, 33894316,
33894323, 33894329, 33894332, 33894334, 33894335, 33894337, 33894339, 33894342,
33894344, 33894351, 33894354, 33971867, 33971918, 34107103, 33894315, 33894331,
33894346, 33894348, 33894350, 33894352, 33898455, 33900759, 33900761, 33900762,
33900763, 33900858, 33900859, 33900862, 33900864, 33900983, 33900985, 33900986,
33900987, 33901091, 33971921, 33986898, 34017749, 33900765, 33900856, 33900979,
33900982, 33901098, 33901099, 33901100, 33901116, 33901117, 33901120, 33901122,
33901127, 33901128, 33901717, 33901720, 33901722, 33901725, 33901726, 33901729,
33901731, 33901732, 33901733, 33901768, 33901769, 33986886, 33986901, 33901785,
33905598, 33905600, 33905603, 33905616, 33911445, 33911516, 33911538, 33911539,
33911545, 31532377, 33980309, 34015702, 33976453, 33986567, 33986896, 33986881,
33922356, 33922369, 33922377, 33936899, 33936906, 33946315, 33947259, 33967350,
33967359, 33967360, 33967379, 33976458, 33976464, 33981768, 33900984, 33955816,
34060830, 34063624, 34063632, 34063635, 34063640, 34066577, 34107131, 34107154,
33901092, 33936893, 34022181, 33951280, 33951457, 33951297, 33951543, 33955757,
33955758, 33955763, 33955764, 33955766, 33955768, 33955769, 33955772, 33955774,
33901115, 33955838, 33980283, 33986853, 33951472, 33951288, 34107168, 33967362,
33924661, 33933925, 33947910, 33930113, 33947939, 33967390, 34011820, 34071173,
34063637, 34066566, 34107128, 34107135, 34107167, 33897340, 33911638, 33897331,
33951285, 33915921, 33915953, 33915958, 33922383, 33917442, 33922372, 33897321,
33897325, 33897328, 33897343, 33905501, 33905503, 33905509, 33905511, 33905513,
33905517, 33905519, 33905522, 33905525, 33905526, 33911604, 33911610, 33911628,
33911633, 33911641, 33917441, 33917450, 34063614, 34063617, 34107397, 34054493,
33986874, 33901096, 33901106, 33951118, 33917459, 33933915, 33933916, 33933917,
33933920, 33933922, 33946307, 33946319, 33946322, 33947256, 33976487, 33947904,
34017792, 33947936, 33979475, 33979479, 33955818, 31689589, 34022188, 34066507,
34066526, 34071159, 33955813, 34017820, 33900855, 33905428, 33971835, 34060835,
33933905, 33936878, 33946305, 33946311, 33946317, 33947900, 33967377, 33967383,
33967384, 33967387, 33967388, 33967396, 33967398, 33967406, 33967409, 33967410,
33967411, 33971813, 33971814, 33971822, 33971823, 33971826, 33971833, 34017807,
34017809, 34017815, 34017817, 34017819, 34017821, 34022169, 34022174, 34022177,
34022183, 34022184, 34022187, 34071181, 34071216, 34071217, 34107247, 34107268,
34107404, 33897318, 33897323, 33897336, 33905506, 33905512, 33905515, 33905523,
33905524, 33911605, 33911612, 33911615, 33911616, 33911623, 33911626, 33986340,
34017731, 33980293, 33992544, 33933907, 33933932, 33936849, 33947899, 33951474,
34017816, 33905611, 33894392, 33894410, 33894585, 33986829, 33951469, 33947884,
34022186, 33905580, 33946301, 33951496, 33951555, 33959547, 33911596, 33971836,
33971877, 33971891, 33971902, 33971903, 33971906, 33980276, 33986331, 33986350,
33986547, 33986560, 33986883, 33986895, 33986899, 33986908, 33986910, 33997570,
33363069, 33967341, 33986919, 33900710, 33900758, 33900861, 33900978, 33901095,
33901119, 33901124, 33901125, 33901126, 33901718, 33901719, 33901721, 33901723,
33901724, 33901727, 33901730, 33901734, 33901736, 33901738, 33901739, 33901741,
33901742, 33901743, 33901744, 33901745, 33901746, 33901747, 33901748, 33901749,
33901750, 33901751, 33901752, 33901754, 33901755, 33901756, 33901757, 33901758,
33901759, 33901763, 33901764, 33901765, 33901766, 33901767, 33901778, 33901779,
33901780, 33901781, 33901790, 33901791, 33904911, 33904912, 33904916, 33933921,
33933923, 33933926, 33933927, 33933928, 33936854, 33936857, 33946297, 33947252,
33997561, 33997579, 34011828, 34015705, 34015711, 34017732, 34017737, 34017743,
33971919, 33971923, 33992541, 33938360, 33955809, 33959571, 33986832, 34054503,
33938365, 33980306, 33905499, 33905586, 33905626, 33911509, 33911546, 33936896,
33946299, 33981763, 33898430, 33898434, 33898438, 34063623, 34107141, 33951270,
33911483, 34017730, 33986836, 33986838, 34052694, 33979550, 33979554, 33986791,
33075368, 33894415, 33894418, 33980271, 33980273, 34071133, 34071158, 33997550,
33947890, 33955819, 33955852, 33959540, 33946312, 33946320, 33947253, 33947255,
33951291, 33951452, 33951465, 33951499, 33951504, 33951516, 33951549, 33951558,
33951581, 33894582, 34011817, 33955812, 33911562, 33947920, 33986893, 33990252,
33997571, 33997580, 34011830, 33959539, 33933910, 33933914, 33933918, 33933919,
33946306, 33946316, 33947248, 33947257, 33947260, 33947893, 33947894, 33947917,
33947919, 33947925, 33947929, 33967342, 33967414, 33981784, 34017746, 33997577,
33911435, 33922358, 33986900, 33986909, 33898504, 33911606, 33911613, 33981770,
33894394, 33894594, 33951267, 31529555, 33894257, 33894409, 33905614, 33911520,
33971819, 33967355, 34063639, 33951121, 33915951, 33933888, 33936852, 34071155,
33905596, 33905599, 33905615, 33905617, 33905625, 33911447, 33911448, 33911462,
33911502, 33911518, 33911533, 33911536, 33911551, 33911555, 33947938, 34071231,
33951453, 34052689, 34054504, 33894592, 33894419, 33894583, 33894591, 33898505,
33905505, 33905508, 33959559, 33356501, 33915909, 33967352, 33971820, 34071206,
33951092, 33951442, 33955815, 33959556, 33951420, 33951450, 33955792, 33955814,
33955828, 33955841, 33971900, 33976432, 34015709, 34017735, 33915944, 33986916,
33997551, 33980295, 33986336, 33986545, 31561638, 33894321, 33894349, 33911510,
34054507, 33951458, 33905595, 33938922, 33951444, 30540230, 33894252, 30874406,
33951466, 33981764, 33915945, 33911530, 33904934, 33911452, 34052663, 34052688,
31562031, 33938364, 33955848, 33959546, 33959554, 33959555, 33959605, 33981791,
33981798, 30476121, 33959549, 33959567, 33955753, 33951131, 33951407, 33951464,
33894416, 33955776, 34015717, 30476106, 30573033, 33905445, 33905471, 33905475,
33905491, 33905578, 33894569, 34071211, 34071235, 34107425, 34017803, 34066491,
34066492, 34066498, 34066505, 34107371, 34107388, 33938923, 34017801, 33980310,
33981774, 34017739, 34017761, 34063621, 34063633, 34066575, 34107159, 33911526,
33915915, 33915936, 33915940, 33915947, 33915952, 33915954, 33915955, 33897333,
33905510, 33981771, 33980267, 33997572, 34017804, 33915935, 33915937, 33915949,
30416301, 30493029, 30523113, 30540981, 30880107, 31490863, 31491441, 31491443,
31832728, 32419784, 33915900, 33915913, 33950577, 33951289, 31003144, 31005264,
33905623, 34071204, 33980282, 33976423, 33911598, 33951491, 33951511, 33976451,
33905579, 33905583, 33976433, 34015708, 33894417, 33894424, 33967347, 33947933,
33971884, 33971917, 33971920, 33971924, 33971925, 33971937, 33971940, 33971949,
33936894, 33947262, 33947898, 33947901, 33947902, 33947903, 33947905, 33947907,
33947908, 33947913, 33947916, 33947923, 33947943, 33967343, 33967344, 33967346,
34054497, 33971959, 33980303, 33971946, 33951515, 33951522, 34003573, 33915950,
33971840, 31531040, 33971954, 33981773, 33981775, 33981776, 33936910, 33955797,
33959563, 33959564, 33959565, 34071143, 33894414, 33951546, 33986552, 33946308,
33947254, 33967353, 33967357, 33967364, 33967366, 33967373, 33967392, 33986929,
33915918, 33915920, 33915938, 33911441, 33905584, 33901775, 33901789, 33904939,
33905426, 33905429, 33905431, 33905437, 33905439, 33905448, 33905450, 33905464,
33905465, 33905469, 33905479, 33905481, 33905489, 33905490, 33905498, 33905588,
33905593, 33905594, 33905597, 33905601, 33905602, 33905604, 33905607, 33905612,
33911443, 33911451, 33911466, 33911472, 33911508, 33911513, 33911515, 33911521,
33911522, 33911523, 33911524, 33911525, 33911527, 33911529, 33911531, 33911534,
33911537, 33911567, 33911576, 34017818, 34022167, 34022172, 34022182, 34066481,
34071192, 34107410, 33981786, 33951567, 34107160, 33946304, 33947263, 33898454,
33981783, 33986876, 34052696, 33946298, 33971837, 33955842, 33938362, 33955807,
33981800, 33981802, 33981803, 34054496, 33981812, 33986839, 33986841, 33992543,
34052654, 34052687, 34052691, 34054509, 34107177, 33951412, 33979557, 33894552,
33898428, 33898440, 33898445, 33898447, 33898448, 33929480, 33929481, 33929483,
33929484, 33929487, 33929488, 33929489, 33929490, 33929492, 33929493, 33929494,
33929495, 33929496, 33929497, 33929498, 33929499, 33929500, 33929501, 33929503,
33929504, 33929505, 33929507, 33929509, 33929510, 33929511, 33929512, 33929513,
33929514, 33929516, 33929517, 33929519, 33929521, 33929522, 33929524, 33929525,
33929526, 33929527, 33929530, 33929531, 33929532, 33929533, 33929535, 33929536,
33929538, 33929539, 33929540, 33930010, 33930011, 33930014, 33930015, 33930017,
33930018, 33930019, 33930020, 33930021, 33930024, 33930025, 33930026, 33930027,
33930028, 33930030, 33930031, 33930032, 33930033, 33930034, 33930036, 33930038,
33930039, 33930040, 33930041, 33930042, 33932675, 33932676, 33932677, 33932680,
33932682, 33932683, 33932684, 33932685, 33932686, 33932690, 33932692, 33932693,
33932694, 33932695, 33932696, 33932697, 33932698, 33932699, 33932701, 33932702,
33932703, 33932704, 33932705, 33932713, 33932717, 33932720, 33932721, 33932724,
33932725, 33932726, 33932727, 33932728, 33932729, 33932731, 33932733, 33932737,
33932738, 33932739, 33932740, 33932743, 33924663, 33924664, 33924681, 33924685,
33924686, 33924687, 33924688, 33924689, 33924690, 33924693, 33924694, 33924698,
33930101, 33992538, 33894420, 34107147, 33881444, 33911444, 33938927, 33955786,
33981788, 33911630, 33950571, 33904879, 33933890, 33990275, 33951416, 33951274,
33951281, 30856112, 33980312, 34066563, 33915923, 33915924, 33915963, 33922355,
33997568, 33921044, 33955749, 33955849, 33894287, 33938356, 33938357, 33938359,
33938928, 33951441, 33951459, 33955756, 33955770, 33955778, 33955779, 33955780,
33955781, 33955782, 33955784, 33955785, 33955787, 33955788, 33955789, 33955790,
33955791, 33955793, 33955795, 33955796, 33955798, 33955800, 33955801, 33955805,
33955830, 33955846, 33955847, 33955853, 33959560, 33959561, 33959562, 33959568,
33959572, 33959573, 33959574, 33959602, 33959603, 33959609, 33981808, 33981809,
33986865, 33992540, 33992542, 33992545, 33992547, 33992549, 33992550, 33992552,
33992553, 33992554, 33992555, 33992556, 33992557, 33992558, 33992559, 33992560,
33992561, 33992562, 33992563, 33992564, 33992565, 33992566, 33992567, 33992568,
33992571, 33992572, 34022190, 34022191, 34022193, 34022194, 34022196, 34022197,
34022199, 34022200, 34052635, 34052637, 34052638, 34052641, 34052642, 34052643,
34052645, 34052646, 34052647, 34052652, 34052656, 34052657, 34052665, 34052671,
34052672, 34052675, 34052676, 34052677, 34052679, 34052683, 34052684, 34052692,
34052695, 34054492, 34054494, 34054500, 34054510, 34054512, 34054532, 34054534,
34060185, 34060186, 34060187, 34060188, 34060189, 34060190, 34060193, 34060194,
34060195, 34060196, 34060200, 34060201, 34060205, 34060209, 34060210, 34060214,
34060215, 34060216, 34060819, 34060820, 34060824, 33894574, 34071144, 33900863,
33901123, 33901740, 33901760, 33901772, 33901776, 33901783, 33901784, 33901786,
33901788, 33904877, 33904915, 33904918, 33905454, 31626298, 31662749, 31762660,
33070524, 33233406, 33947924, 33894318, 33894336, 33894338, 33894343, 33894345,
33894347, 33894353, 33898453, 33898456, 33900860, 34022214, 33946285, 33946288,
34052666, 33950581, 33894584, 33894593, 33897332, 33951507, 34063628, 34066571,
33897352, 33897354, 33955794, 33986835, 33986842, 34052690, 34054498, 33951443,
33951286, 33951290, 33980265, 33980307, 33981766, 33981767, 33981769, 33997576,
34017738, 34022178, 33930112, 33930118, 33933896, 33933901, 33933924, 33933930,
33936851, 33936853, 33936855, 33936856, 33936880, 33936881, 33936883, 33936884,
33936885, 33936888, 33936891, 33936895, 33936897, 33936898, 33936903, 33936904,
33986341, 33986912, 34011818, 33947937, 33967354, 33967361, 33967368, 33967369,
33967380, 33967386, 33967389, 33971922, 33971927, 33971942, 33971944, 33976461,
34071168, 33951124, 33959569, 33986833, 34071131, 34071140, 34071218, 33951548,
33065288, 33070529, 33901097, 33901101, 33901118, 33955845, 33894412, 33911590,
34022173, 33894578, 33894590, 33898503, 33901090, 33938929, 33894567, 33894586,
33986904, 33894589, 33980277, 33951584, 34107402, 33936859, 33936861, 33936886,
33936892, 33936907, 33981779, 33986837, 34054501, 34054502, 34107156, 33947934,
33947940, 33955799, 30559207, 31275938, 30587151, 33814952, 33955835, 33936909,
33936912, 33946300, 33946321, 33947896, 33947921, 33922371, 33971945, 33986544,
34066487, 34066510, 34107280, 33976445, 33976448, 33976450, 33976452, 33976457,
33976459, 33976460, 33976465, 33922296, 33955773, 33955817, 33955836, 33955837,
33955844, 33955851, 33959542, 30553849, 30553852, 31305464, 34015706, 33894401,
33947912, 33933900, 33980289, 33933881, 33976422, 33979498, 33979520, 33979556,
33946310, 34071198, 34071203, 34107240, 34107415, 34107420 Military serial
numbers: 33894425, 33894255, 33997567, 33959578, 33894287, 33938356, 33938357,
33938359, 33938928, 33951441, 33951459, 33955756, 33955770, 33955778, 33955779,
33955780, 33955781, 33955782, 33955784, 33955785, 33955787, 33955788, 33955789,
33955790, 33955791, 33955793, 33955795, 33955796, 33955798, 33955800, 33955801,
33955805, 33955830, 33955846, 33955847, 33955853, 33959560, 33959561, 33959562,
33959568, 33959572, 33959573, 33959574, 33959602, 33959603, 33959609, 33981808,
33981809, 33986865, 33992540, 33992542, 33992545, 33992547, 33992549, 33992550,
33992552, 33992553, 33992554, 33992555, 33992556, 33992557, 33992558, 33992559,
33992560, 33992561, 33992562, 33992563, 33992564, 33992565, 33992566, 33992567,
33992568, 33992571, 33992572, 34022190, 34022191, 34022193, 34022194, 34022196,
34022197, 34022199, 34022200, 34052635, 34052637, 34052638, 34052641, 34052642,
34052643, 34052645, 34052646, 34052647, 34052652, 34052656, 34052657, 34052665,
34052671, 34052672, 34052675, 34052676, 34052677, 34052679, 34052683, 34052684,
34052692, 34052695, 34054492, 34054494, 34054500, 34054510, 34054512, 34054532,
34054534, 34060185, 34060186, 34060187, 34060188, 34060189, 34060190, 34060193,
34060194, 34060195, 34060196, 34060200, 34060201, 34060205, 34060209, 34060210,
34060214, 34060215, 34060216, 34060819, 34060820, 34060824
International
serial numbers: 33947246, 33947247, 33892605, 33893092,
33894357, 33894359,
33894360, 33894366, 33894369, 33894370, 33894373, 33894378, 33894380, 33933865,
33933874, 33933882, 33933948, 33946270, 33946278, 34003572, 34003579, 34003584,
34003597, 33894325, 33900857, 33930119, 33933884, 33933887, 33933889, 33933892,
33933893, 33933895, 33933898, 33933912, 33933913, 33971956, 34071200, 34107253,
34107377, 34107381, 33894298, 33894427, 33950568, 33950569, 33959558, 33959599,
34052644, 34052668, 34052670, 34060818, 34060845, 34060846, 34060848, 34063584,
34063586, 34063591, 34063629, 34063634, 34066565, 34066569, 34066580, 34066586,
34107066, 34107083, 34107096, 34107109, 34107115, 34107120, 34107169, 33946287,
33986792, 33986799, 33990253, 33990273, 34011810, 34011815, 34011816, 34011826,
34015710, 34022166, 34022171, 34022179, 34022180, 34066504, 34066516, 34066517,
34066518, 34066520, 34066521, 34066522, 34066523, 34066524, 34066525, 34066528,
34066529, 34066530, 34066531, 34066532, 34071145, 34071160, 34071161, 34071163,
34071164, 34071166, 34071169, 34071170, 34071172, 34071174, 34071179, 34071182,
34071183, 34071184, 34071194, 34071196, 34071199, 34071201, 34071215, 34107258,
34107320, 34107386, 34107400, 34107403, 34107409, 34107413, 34107414, 34107416,
34107417, 34107424, 34107433, 34060211, 34060831, 34060838, 34060839, 34063577,
33892622, 33893090, 33894358, 33894379, 33894568, 33894579, 33894581, 33894588,
33971961, 33971962, 33892602, 33893076, 33893079, 33893085, 33946272, 33947877,
33905605, 33905610, 33905613, 33911432, 33915932, 33915934, 33915942, 33915948,
33922354, 33971943, 33971947, 33971955, 33976434, 33976436, 33976437, 33976440,
33976443, 33981765, 33986907, 34017812, 34071188, 33981806, 33986830, 33894245,
33894246, 33894247, 33894248, 33894249, 33894254, 33894256, 33894292, 33894293,
33894295, 33894296, 33894297, 33894299, 33894300, 33894301, 33894302, 33894303,
33894304, 33894305, 33894312, 33894313, 33894314, 33894393, 33894395, 33894396,
33894397, 33894398, 33894399, 33894400, 33894402, 33894403, 33894405, 33894407,
33894408, 33894575, 33894576, 33894595, 33950445, 33951111, 33959537, 33981804,
33981807, 33981810, 33981811, 33986816, 33986817, 33986818, 33986819, 33986820,
33986821, 33986822, 33986824, 33986828, 33986831, 33986834, 34063626, 34063641,
34066564, 33893102, 34011831, 34017800, 34071132, 33894391, 34107239, 34107270,
34107330, 34107339, 34107391, 34107392, 34107398, 34107399, 33986928, 33990259,
33881434, 33881439, 33881441, 33892607, 33892617, 33893073, 33893081, 33893094,
33894550, 33898433, 33898443, 33898444, 33932691, 33932735, 33933862, 33933880,
33933933, 33933934, 33933935, 33933936, 33933940, 33933943, 33946284, 33946290,
33946291, 33946292, 33947871, 33947873, 33881436, 33893100, 33893103, 33947878,
33947887, 34003621, 33892589, 33892591, 33892592, 33892596, 33892597, 33892598,
33892600, 33892604, 33892608, 33892610, 33892615, 33892619, 33892621, 33893077,
33893080, 33893084, 33893087, 33893089, 33893091, 33893095, 33892606, 33892609,
33893088, 33894372, 34003564, 34003588, 34003590, 34003605, 34003611, 34003619,
34003628, 34011697, 34011704, 34011707, 33881438, 33929478, 33932732, 33933871,
33947881, 33947889, 33979529, 33979559, 34003594, 33905606, 33905624, 33911517,
33922360, 33922361, 33922366, 33930126, 33936882, 33936890, 33936901, 33936905,
33936908, 33946309, 34066514, 33911514, 33911519, 33930111, 33947932, 33971915,
33971930, 33971952, 33971960, 33976435, 33976467, 33980269, 33980292, 33990251,
33990255, 33990257, 33990260, 33990261, 33990264, 33990269, 34017740, 34017797,
33894319, 33894322, 33976473, 33971929, 34066515, 34071147, 34071148, 34071154,
34071156, 33911440, 33915946, 33922365, 33930104, 33976484, 33980284, 34066502,
33976462, 33892612, 33892613, 33892614, 33892616, 33892618, 33893074, 33893082,
33893086, 33893093, 33893096, 33893099, 33893107, 33894363, 33894368, 33894549,
33933875, 33933879, 33933951, 33933957, 33946275, 33946279, 33946294, 33946295,
33947869, 33947870, 33947872, 33947874, 33947879, 33947882, 33947885, 33947888,
33947892, 33976405, 33979493, 33979510, 33986796, 33986798, 33986801, 33986802,
33986803, 33986804, 33986805, 33986806, 33986810, 33986812, 33986813, 34003577,
34003591, 34003606, 34003608, 34003613, 34003620, 34003623, 34003624, 34003629,
34011699, 34011700, 34011701, 33915959, 33922373, 33922374, 33922379, 33922380,
33922381, 33924667, 33924668, 33924670, 33924677, 33933899, 33933908, 33936858,
33936900, 33936913, 33971912, 33971931, 33971951, 33971957, 33971958, 33976438,
33976439, 33976442, 33976444, 33976449, 33976466, 33976469, 33980302, 33981785,
33986347, 33986875, 33986914, 33986918, 33990263, 34015701, 34015716, 34015732,
34015743, 34017772, 34017802, 34017811, 34022165, 34022170, 34066480, 34066482,
34066484, 34066485, 34066486, 34066488, 34066489, 34066490, 34066494, 34066495,
34066497, 34066499, 34066500, 34066501, 34066503, 34071162, 34071167, 34071177,
33894422, 33897347, 33950575, 33950579, 33951103, 33951401, 33894250, 33894570,
33897330, 33897334, 33897345, 33897349, 33897351, 33905504, 33951122, 33951127,
33951587, 33951591, 33955843, 33959557, 33959604, 33981801, 34052678, 34052680,
34054490, 34063618, 33897348, 33955850, 33959543, 33959551, 33992548, 34063613,
33894251, 33894294, 33897338, 33897339, 33951271, 33951402, 34107069, 33922297,
33950447, 33950452, 33950453, 33950454, 33950455, 33950456, 33950457, 33950570,
33950572, 33950573, 33950576, 33950578, 33955783, 33959541, 33959548, 34107110,
33884883, 33955777, 33986326, 33893098, 33893104, 33893105, 33893106, 33894356,
33894361, 33894362, 33894365, 33894371, 33894374, 33894376, 33894377, 33894554,
33898432, 33898435, 33898436, 33898446, 33932681, 33932689, 33932741, 33932744,
33933859, 33933861, 33933863, 33933868, 33933869, 33933876, 33933877, 33933937,
33933942, 33933945, 33946269, 33946282, 33946289, 33979537, 33979555, 33979558,
33979563, 33986793, 33986795, 33986797, 33986800, 33986807, 33986808, 33986809,
33986811, 33986814, 33986815, 33991479, 33991480, 33991482, 33991485, 33991486,
33991487, 33991492, 33991493, 33991495, 33991496, 33991497, 33991498, 34003562,
34003563, 34003566, 34003575, 34003580, 34003586, 34003595, 34003602, 34003603,
34003607, 34003609, 34003612, 34003626, 34003630, 34011714, 33904919, 33905433,
33905442, 33905446, 33905447, 33905449, 33905463, 33905467, 33905468, 33905577,
33905591, 33905618, 33905619, 33911511, 33915883, 33915886, 33930109, 33930110,
33930114, 33930116, 33933929, 33936911, 34017745, 34017791, 33819592, 33881450,
33893078, 33893083, 33893101, 33894367, 33894375, 33894381, 33894383, 33894384,
33894385, 33894386, 33894388, 33894389, 33894390, 33932679, 33933858, 33933870,
33933872, 33933944, 33933886, 33936902, 33947930, 34003598, 34022201, 33976480,
33976481, 33976482, 33976483, 33917460, 33921054, 33921056, 33951594, 34060847,
33894291, 33894571, 33921048, 33950446, 33950449, 33950574, 33950583, 33955834,
34060203, 34060207, 34060212, 34060817, 34060821, 34060825, 34060828, 34060832,
34060836, 34060852, 34060853, 34063566, 34063567, 34063568, 34063571, 34063573,
34063574, 34063575, 34063579, 34063582, 33955808, 33955810, 33955811, 33894596,
33898431, 33898441, 33898442, 33900686, 33894364, 33894553, 33898429, 33898449,
33929477, 33929479, 33933867, 33946286, 33947876, 33976425, 33979505, 33991484,
33991489, 34011703, 33929476, 33933939, 34003592, 34003593, 33894551, 33932678,
34011696, 33932722, 33933864, 33933866, 33933938, 33933941, 33933949, 33933950,
33933952, 33933953, 33933954, 33922359, 33894333, 33915957, 33915960, 33922364,
34011834, 33894324, 33915927, 33922362, 33922370, 33947911, 33947914, 33997578,
34011813, 34015723, 34066506, 34066509, 34066511, 33915933, 33922363, 33922367,
33922368, 33922375, 33924666, 34107387, 33915943, 33924700, 33930108, 33930115,
33930120, 33930123, 33933883, 33933885, 33933891, 33933902, 30523635, 33890401,
33892594, 33892599, 33892601, 33892603, 33933860, 33933873, 33933946, 33933947,
33933955, 33933956, 33946267, 33946273, 33946276, 33946280, 33946283, 33947880,
33947891, 33979545, 33986794, 33991477, 33991478, 33991483, 33991494, 33991499,
34003565, 34003589, 34011705, 34011708, 34022206, 34022210, 34022211, 34022212,
33894317, 33924662, 33924671, 33924673, 33924674, 33924676, 33924680, 33930099,
33930100, 33980270, 33980299, 33980305, 33986926, 33986927, 33986930, 33986932,
33990256, 33990258, 33990266, 33997553, 33997574, 33997575, 34011829, 34066496,
34066508, 34066513, 34066519, 34071146, 34071149, 34071150, 34071151, 34071157,
34003578, 33922376, 33922378, 33922382, 33924665, 33924669, 33924672, 33924678,
33924683, 33924691, 33930141, 33933903, 33814107, 33892588, 33892590, 33892595,
33892611, 33892620, 33893072, 33893075, 33933897, 33947895, 33947906, 33947918,
33947926, 33947928, 33922295, 33951064, 33894253, 33959545, 33938358, 33950582,
33950585, 33951084, 33951117, 33951119, 33951120, 33951123, 33951125, 33951126,
33951132, 34052681, 33938361, 33955823, 33959544, 33959553, 33959566, 33959607,
33959608, 33981790, 34054517, 33938925, 33950586, 33951074, 33951115, 33951116,
34022198, 33959600, 34054528, 34054531, 33894387, 34003571, 34003574, 34003576,
34003596, 34003599, 34011715, 34011717, 34011722, 33905620, 34015714, 34017733,
34017798, 34017805, 34071191, 34060841, 34066568, 33915902
RECALLING
FIRM/MANUFACTURER Medtronic Emergency Response Systems, Inc., Redmond, WA
REASON
Devices with v38 system software do not display a
"LOW BATTERY: CONNECT TO AC POWER" message when the monitor is on backup (DC)
battery power and may shut down without warning.
VOLUME OF PRODUCT IN
COMMERCE 2,831 devices
DISTRIBUTION Nationwide and
Internationally
WEEK ENDING SEPTEMBER 30
PRODUCT GE Precision 500D
Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting
of an X-ray generator; angulating table with x-ray Tube, collimator and image
intensifier; wall stand; Overhead tube suspension; operator console and digital
archive system,
CODE All serial numbers
affected
RECALLING FIRM/MANUFACTURER General Electric Med Systems LLC,
Waukesha WI,
REASON Systems are non-compliant with Federal Performance Standard
Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems
allow the production of x-rays when the primary protective barrier is not in
position to intercept the entire cross section of the useful beam
VOLUME
OF PRODUCT IN COMMERCE 1,289 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Hil-Rom Affinity Three
Birthing Bed, Model P3700,
CODE All units
distributed after October 2000 and equipped with the 12VAC accessory outlet
option.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN,
REASON The cable on the auxiliary outlet may become pinched, which
may result in an electrical short with melting of the plastic transformer and
the emission of smoke.
VOLUME OF PRODUCT IN COMMERCE 9,324
beds
DISTRIBUTION Nationwide and Internationally
PRODUCT Therakos Photopheresis
Procedural Kit for use with the UVAR XTS Instrument, Catalog number XT125,
CODE
Lot numbers: U706, U707, U708, U709, U710,
U711, and U712
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Therakos, Inc., Exton, PA,
Manufacturer: Harmac Medical Products, Inc., Buffalo, NY.
REASON
Centrifuge Bowl may
leak.
VOLUME OF PRODUCT IN COMMERCE 1,315
units
DISTRIBUTION Nationwide and Internationally
PRODUCT BD™ BBL™ Staphyloslide
Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500
tests/kit), packaged in a kit configuration with test reagents and labware,
CODE
Lot Number / Exp. Date 16629910 April 30,
2007 16562410 April 30, 2007 16629920 April 30, 2007 16562420 April 30,
2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton
Dickinson & Co, SparksMD,
Manufacturer: Oxoid, Ltd, Basingstoke, UK.
REASON
False Negative Staphylococcus
aureus results which could prevent infected patients from receiving
antimicrobial treatment; due to the failure of the Positive Control to react
within 20 seconds. The failure is due to reduced reactivity of the latex
component.
VOLUME OF PRODUCT IN COMMERCE 1,572
kits
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Conmed System 2500
Electrosurgical Unit, REF 60-8011-SYS,
b) Conmed
System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003,
CODE
a) Serial
numbers: 06GGN 001 thru 009, 06FGN 001 thru 010;
b) Serial Numbers: 06GGP
004, 06GGP 005, 06GGP 009, 06GGP 011, 06GGP 012, 06GGP 024, 06GGP 027 thru
030, 06GGP 057 thru 059, 06GGP 090 thru 092, 06GGP 131 thru 140, 06GGP
141 thru 144, 06FGP 022, 06FGP 023, 06FGP 029 thru 046, 06FGP 048 thru 056,
06FGP 062 thru 071, 06FGP 073 thru 079, 06FGP 090, 06FGP 106, 06FGP 107,
06FGP 110 thru 112
RECALLING FIRM/MANUFACTURER Conmed Electrosurgery,
Centennial, CO
REASON Wrong size
capacitor installed in electrosurgical generator could malfunction, causing
muscle stimulation or delay in therapy.
VOLUME OF PRODUCT IN
COMMERCE 103 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Solara 2G manual
wheelchair
b) Solara Spree GT manual wheelchair
c) Solara Spree XT (SPRXT) manual
wheelchair
CODE
a) 06EE008858, 06EE010422, 06EE010432, 06EE010434, 06EE010442, 06EE010453, 06EE010454, 06EE010745,
06EE010747, 06EE010749,
06EE010758, 06EE010799,
06EE010804, 06EE010810, 06EE011357, 06EE011378, 06EE011379, 06FE000048, 06FE000050, 06FE000054,
06FE000055, 06FE000057,
06FE000985, 06FE001000,
06FE001012, 06FE001604, 06FE001612, 06FE001625, 06FE006654, 06FE006661, 06FE007243, 06FE008820,
06FE008829, 06FE008832,
06FE009212, 06FE010083;
b) 06EE011382, 06FE000065, 06FE001632, 06FE001635, 06FE006693, 06FE007246;
c) 06FE009232
RECALLING
FIRM/MANUFACTURER Invacare Corp., Elyria, OH,
REASON The wheelchairs with the Travel Ready Option
(TRRO)
may contain incorrectly finished oval tie down brackets. The inner edge of the
bracket may cause the tie-down straps (used to tie down the chairs during
transport) to fray or be cut.
VOLUME OF PRODUCT IN COMMERCE 43
wheelchairs
DISTRIBUTION Nationwide and Canada
PRODUCT Boston Scientific Cutting
Balloon Ultra2 Monorail Device,
CODE Material
Number (UPN) / Catalog Number / Lot/Batch #: H749CBM200060 / CBM20006 / EG0438
& EG0499; H749CBM200100 / CBM20010 / EG0427; H749CBM225060 / CBM22506 /
EG0448 & EG0471; H749CBM225100 / CBM22510 / EG0444 & EG0502;
H749CBM250060 / CBM25006 / EG0439 & EG0472; H749CBM250100 / CBM25010 /
EGO425, EG0440, EG0474 & EG0475; H749CBM250150 / CBM25015 / EG0466;
H749CBM275060 / CBM27506 / EG0420 & EG0487; H749CBM275100 / CBM27510 /
EG0419 & EG0456; H749CBM275150 / CBM27515 / EG0424; H749CBM300060 / CBM30006
/ EG0423, EG0473 & EG0497; H749CBM300100 / CBM30010 / EG0426, EG0441,
EG0465, EG0485; H749CBM300150 / CBM30015 /EG0443 & EG0418; H749CBM325060 /
CBM32506 / EG0500; H749CBM325100 / CBM32510 / EG0422 & EG0501; H749CBM325150
/ CBM32515 / EG0467; H749CBM350060 / CBM35006 / EG0437; H749CBM350100 / CBM35010
/ EG0349, EG0428, EG0468; H749CBM350150 / CBM35015 / EG0421 & EG0486;
H749CBM375060 / CBM37506 / EG0503; H749CBM375100 / CBM37510 / EG0457;
H749CBM375150 / CBM37515 / EG0455; H749CBM400060 / CBM40006 / EG0504;
H749CBM400100 / CBM40010 / EG0442 & EG0498; H749CBM400150 / CBM40015 /
EG0476
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston
Scientific, Maple Grove ,MN,
Manufacturer: Boston Scientific Corporation,
etterkenny,
Ireland.
REASON Lack of assurance
of sterility (pre-sterilization bioburden limits exceeded)
VOLUME OF
PRODUCT IN COMMERCE 1,000
devices
DISTRIBUTION Nationwide
PRODUCT Stryker Power-Pro Powered
Ambulance Cot, Model 6500,
CODE All units with a
serial number lower than 060739380
RECALLING
FIRM/MANUFACTURER Styker Medical Division of Styker Corp., Portage, MI,
REASON
The head section wheel assembly may flex outward
from the cot because the head section wheel bolts, which hold the assembly
upright, may back out.
VOLUME OF PRODUCT IN COMMERCE 2,033
units
DISTRIBUTION Nationwide and Internationally
PRODUCT ADVIA Centaur CP System,
Automated Immunoassay Analyzer, Part/Catalogue Number 086-A001,
CODE All ADVIA Centaur CP systems using software versions
3.1 and 3.2.
RECALLING FIRM/MANUFACTURER Bayer Healthcare, LLC
(Diagnostics Division), Tarrytown, NY,
REASON Sample/Patient mis-identification (software defect) the system can associate a test result and
sample identification (SID) with an incorrect patient name when the Patient
Demographics feature is used and the Patient Identification (PID) field is left
blank.
VOLUME OF PRODUCT IN COMMERCE 254
units
DISTRIBUTION Nationwide and Internationally
PRODUCT UniCel Dxl 800 Access
Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer
CODE 221208F (exp 6/9/07), 221209F(exp 6/9/07), 221210F
(exp 6/10/07), 221211F (exp 6/10/07), 221212F (exp 6/12/07), 221213F (exp
6/12/07), 221214F (exp 6/13/07), 221215F (exp 6/13/07), 221216F (exp 6/14/07),
221217F (exp 6/14/07), 221218F (exp 6/15/07), 221219F (exp 6/15/07), 221220F
(exp 6/16/07), 221221F (exp 6/16/07), 221222F (exp 6/17/07), 221223F (exp
6/17/07), 221224F (exp 6/19/07), 221225F (exp 6/19/07), 221226F (exp 6/20/07),
221227F (exp 6/20/07), 221228F (exp 6/21/07), 221229F (exp 6/21/07); All
software versions
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc,
BreaCA,
Manufacturer: Beckman Coulter Inc, Florence, KY.
REASON
The neck of the wash buffer cube can be
extended higher than intended possibly causing the system to aspirate air
instead of buffer before the buffer container is empty without the system
immediately indicating that the supply is empty. This may lead to incorrect
assay results.
VOLUME OF PRODUCT IN COMMERCE 12,947
units
DISTRIBUTION Nationwide and Internationally
PRODUCT OptiBond Solo Plus
Self-Etch Adhesive System, Part Number 31966,
CODE Lot numbers: 448798, 449556 and
451706
RECALLING FIRM/MANUFACTURER Kerr Corp, Orange, CA
REASON
Mis-pack/mis-label: The OptiBond Self Etch Primer
and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in
reverse order. Application of these products in reverse order may result in
compromised bond strength.
VOLUME OF PRODUCT IN COMMERCE 247 kits
(50 unidose pouches/kit)
DISTRIBUTION Nationwide and
Internationally
PRODUCT Ruggles(tm) Leyla Ball
Joint Clamp, MODEL/CATALOG #: R2383. The Leyla Ball Joint Clamp is part of the
Table Mounting Hardware that is used with the Leyla Retractor System. The Leyla
Table Mounting Hardware consists of the Ball Joint Clamp, the Rigid Holding Rod,
the Coupling Head, and the Coupling Head Turn Table. The Ball Joint Clamp is
available individually or as part of the Table Mount Set. The Table Mounting
Hardware are attachments to operating room surgical tables. The product is
supplied non-sterile and may be packaged individually or as part of the Table
Mount Set,
CODE 143 601736
RECALLING
FIRM/MANUFACTURER
Recalling Firm: J. Jamner Surgical Instruments,
Inc., Hawthorne, NY
Manufacturer: Rebstock, Durbheim, Germany.
REASON The Ruggles(tm) Leyla Ball Joint Clamp may not properly
tighten onto the Rigid Holding Rod. Although this condition can be observed
during assembly, if the device were to be used during surgery, any attachments
to the Rigid Holding Rod could move.
VOLUME OF PRODUCT IN
COMMERCE 8 units
DISTRIBUTION MS, IL, WI, and TX
PRODUCT Porex Nostril Retainers,
Catalog #7241, Size 4,
CODE Lot number:
B002E05N
RECALLING FIRM/MANUFACTURER
Recalling Firm: Porex
Surgical, Inc., Newnan, GA
Manufacturer: G. E. Silicones, Lic, Waterford, NY.
REASON
Device contains a trace
amount of amine via introduction through an intermediate supplied by a third
party raw material.
VOLUME OF PRODUCT IN COMMERCE 27
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Anti-CD45 Cocktail
antibody in 6 ml vials; Cat. No. AM371-5M,
CODE Lot number AM3710606, Expiration date June
2008.
RECALLING FIRM/MANUFACTURER Biogenex Laboratories, San Ramon CA
REASON
Mislabeling: Anti-CD45 cocktail antibody mislabeled
as Ki-67.
VOLUME OF PRODUCT IN COMMERCE 13
units
DISTRIBUTION Nationwide and Internationally
PRODUCT OASIS® Medical SOFT PLUG® Extended Duration Plug, Reference 6403,
CODE
Lot: LA1105E
RECALLING
FIRM/MANUFACTURER Oasis Medical, Inc., Glendora, CA
REASON Labeled with an incorrect diameter.
VOLUME OF
PRODUCT IN COMMERCE 1,212 pouches
DISTRIBUTION Nationwide
and Internationally