JANUARY 2005
WEEK ENDING JANUARY 15
PRODUCT
Proteus XR/a Radiographic X-ray System; Precision 500D Radiographic/Fluoroscopic
X-ray System
Use: Diagnostic Radiology.
CODE
All.
RECALLING FIRM/MANUFACTURER
GE Healthcare Technologies, Waukesha, WI.
REASON
The units are defective under 21 CFR 1003.2 in that they fail to operate as
required by 21 CFR 1020.31(g) ‚ Positive Beam Limitation (PBL).
VOLUME OF PRODUCT IN COMMERCE
Approximately 2250 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11". Model EX24D.
CODE
Lot No.: 58174875.
RECALLING FIRM/MANUFACTURER
Edwards Lifesciences Research Medical Inc, Midvale, UT.
REASON
Aortic cannula may delaminate and leak where it is bonded to the tip. This could
occur during cardiopulmonary bypass surgery.
VOLUME OF PRODUCT IN COMMERCE
396 units.
DISTRIBUTION
Nationwide.
PRODUCT
a) Easy Go Vac Aspirator, Model PM65.
Portable suction unit.
b) Easy Go Vac Aspirator, Model PM65HG.
Portable suction unit.
CODE
a) Serial Numbers:008360 to 14360 Charger
part number 503974 (Globtek Part #
TM21097CC-5015-1.3 Part No: GS-307-B);
b) Serial numbers 008360 through 14360
Charger part number 503974 (Globtek
Part # GTM21097CC-5015-1.3 Part No:
GS-307-B).
RECALLING FIRM/MANUFACTURER
Precision Medical, Inc. Northampton, PA.
REASON
Battery charger can be overcharged and overheat.
VOLUME OF PRODUCT IN COMMERCE
6,000 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Titanium Orthos Bracket.
CODE
Part Number: 448-6111 and lot numbers:04G21, 04G83, 04J29, 04H108, 04K77. Part
Number:449-6111 and lot numbers: 04G15, 04J5, 04G14, 04H141, 04H77.
RECALLING FIRM/MANUFACTURER
Ormco Corporation, Glendora, CA.
REASON Misassembly. Stainless steel and titanium parts were mistakenly welded together
to construct the device. The weld failed.
VOLUME OF PRODUCT IN COMMERCE
6,257.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Brand name: NIMô EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIMô
EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308. All products
are packaged one unit per box. .
CODE
Product Code: 77 ETN Lot Numbers: 32423300 through 35505400, and 35542200, 35542300,
35542400, 35542500, 35542600, 35543400, 35597200, 35602100, 35633400, 35633600,
35638200, 35638400.
RECALLING FIRM/MANUFACTURER
Medtronic Xomed, Inc., Jacksonville, Fl.
REASON
The firm received six reports of tubes with wires "out of channel" two of which
involved injuried patients. In one case in Germany it was reported that the
patient had soreness of the throat and was discharged after four days. In the
next case the patient had a tracheal wound. It was not clear what caused the
wound.
VOLUME OF PRODUCT IN COMMERCE
22,569 EMG Tubes.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903.
CODE
All serial numbers beginning with C0424.
RECALLING FIRM/MANUFACTURER
Medical Industries America Inc, Adel, IA.
REASON
Units could show an error code and stop functioning.
VOLUME OF PRODUCT IN COMMERCE
74 units.
DISTRIBUTION
Nationwide, Hong Kong, Chile, and Canada.
PRODUCT
a) 14 French Ross Flexiflo Over the Guidewire
Gastrostomy Kit with T-Fasteners (15cm)
for Endoscopic Removal (list #00226).
Single Use Sterile Gastrostomy Kits.
b) 18 French Ross Flexiflo Lap J Laparoscopic
Jejunostomy Kit with Brown/Mueller T-Fastener
Set (List #51174) Assorted Single Use Sterile
Jejunostomy Kits.
c) 14 French Ross Flexiflo Over the Guidewire
Gastrostomy Kit with T-Fasteners (15cm)
for Endoscopic Removal (list #00227).
d) 18 French Ross Flexiflo Over the Guidewire
Gastrostomy Basic Kit with T-Fasteners for
Endoscopic Removal (list # 00228).
e) 18 French Ross Flexiflo Over the Guidewire
Gastrostomy Kit with T-Fasteners for
Endoscopic Removal (list # 00238).
f) 18 French Ross Introducer Complete
Gastrostomy Kit with Brown/Mueller T-Fastener
Set (list # 50190).
g) 22 French Ross Versa-PEG Complete
Gastrostomy Kit, an Over-the-Wire
PEG Method Featuring Tube Removal
without Endoscopy
(list # 50520).
20 French Ross Over-the-Guidewire Basic
h) Gastrostomy KIt with Reinforced Webbed
Bumper for Endoscopic Removal (Basic)
(list # 50728).
i) 20 French Ross Flexiflo Over-the-Guidewire
Complete Gastrostomy KIt with Reinforced
Webbed Bumper for Endoscopic Removal
(list #50738).
j) 20 French Ross Inverta-PEG Over-the-
Guidewire Basic Gastrostomy KIt with
Roll-Tip Bumper (list # 51490).
k) 20 French Flexiflo Inverta-PEG Pull
Technique Basic Gastrostomy KIt with
Roll-Tip Bumper (list # 52000).
l) 10 French Ross Flexiflo Lap J
Laparoscopic Jejunostomy Kit with
Brown/Mueller T-Fastner Set
(list #51442).
CODE
a) Lots: 04639GZ00 and 17182GZ00;
b) Lots: 01528GZ00, 04666GZ00, 08764GZ00,
10840GZ00, 12921GZ00, 14003GZ00, 14019GZ00,
15080GZ00, 17178GZ00, 82485GZ00, 86727GZ00,
88827GZ00, 91053GZ00, 91157GZ00, 94377GZ00,
96466GZ00;
c) Lots: 01487GZ00, 15069GZ00, 94312GZ00;
d) Lots: 01504GZ00, 05675GZ00, 12916GZ00,
15079GZ00, 17181GZ00, 87766GZ00,
90001GZ00, 92215GZ00;
e) Lots: 02581GZOO, 11884GZ00, 17159GZ00;
f) Lots: 02565GZ00, 03600GZ00, 04643GZ00,
05676GZ00, 06719GZOO, 10829GZ00, 10860GZ00,
11893GZ00, 12943GZ00, 13960GZ00, 14011GZ00,
14052GZ00, 15089GZ00, 16134GZ00, 16143GZ00,
18206GZ00, 84569GZ00, 86700GZ00, 88826GZ00,
89942GZ00, 90015GZ00, 91105GZ00, 92199GZ00,
93261GZ00, 94322GZ00, 95410GZ00, 96470GZ00;
g) Lots: 01511GZ00, 09769GZ00, 15086GZ00,
19243GZ00, 88824GZ00;
h) Lots 13959GZ00, 90997GZ00.
i) Lots: 02562GZ00, 04658GZ00, 07738GZ00,
12917GZ00, 15061GZ00, 89905GZ00,
96435GZ00;
j) Lots: 02560GZ00, 08753GZ00, 14028GZ00,
15116GZ00, 17156GZ00, 86714GZ00,
89941GZ00, 93281GZ00;
k) Lots: 04640GZ00, 07725GZ00, 20276GZ00,
85688GZ00, 89904GZ00;
l) Lot: 04622GZ00, 11870GZ00, 13978GZ00,
15105GZ00, 17165GZ00, 18190GZ00,
86722GZ00, 90044GZ00, 95381GZ00.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Columbus, OH.
REASON
Gastrostomy and Jejunostomy primary placement kits which may contain components
that may not have been adequately sterilized, were distributed.
VOLUME OF PRODUCT IN COMMERCE
34,073
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
ACT diff 2 Analyzer (Automated differential cell counter).
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc, Brea, CA.
REASON
Erroneous results issue when MONOJECT blood collection tubes are used during
analysis after tubes are uncapped and recapped then analysed in the closed vial
mode. Results are lower than if cap had not been removed.
VOLUME OF PRODUCT IN COMMERCE
2,709 units.
DISTRIBUTION
Nationwide and Canada.
PRODUCT Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet (3.7m),
Sterile, Single Use, Disposable, Weck Closure Systemsô, Catalog # 394236.
CODE
Lot 3504519.
RECALLING FIRM/MANUFACTURER Weck, Research Triangle Park, NC.
REASON
An incorrect electrosurgical cord was included in some of the packages.
VOLUME OF PRODUCT IN COMMERCE
462 units.
DISTRIBUTION
Nationwide, Singapore.
PRODUCT
Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use),
M3536A (EMS Use).
CODE
Software versions A.02.00 and lower.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA.
REASON
In Software versions below A.02.00, with the sync function enabled and the device
switched from manual to AED, there may be an unexpected delay in delivery of
energy.
VOLUME OF PRODUCT IN COMMERCE
2,520 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Colleague Single Channel Volumetric
Infusion Pumps, product code 2M8151
and 2M8151R; Made in Singapore; monochrome
display screen.
b) Colleague 3 Triple Channel Volumetric
Infusion Pumps, product code 2M8153
and 2M8153R; Made in Singapore; monochrome
display screen.
c) Colleague CX Single Channel Volumetric
Infusion Pumps, product code 2M8161
and 2M8161R; Made in Singapore; color
display screen.
d) Colleague 3 CX Triple Channel Volumetric
Infusion Pumps, product code 2M8163 and
2M8163R; Made in Singapore; color
display screen.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL.
REASON
A software anomaly causes a failure alarm code 12:303 which audibly alarms and
stops the function of all channels in use. This causes an interruption in therapy,
which may result in a risk to the patient.
VOLUME OF PRODUCT IN COMMERCE
199,456 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Hill-Rom CareAssist Bed; model P1170.
CODE
All units shipped prior to September 22, 2004.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN.
REASON
Warning label containing instructions for proper electrical grounding was not
attached.
VOLUME OF PRODUCT IN COMMERCE
1,825 units.
DISTRIBUTION
Nationwide, Canada and Saudi Arabia.
PRODUCT
Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer
semi-constrained cemented prosthesis.
CODE
Serial numbers 0638851-0638871, expiration date October 2009.
RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL.
REASON
Implant was identified incorrectly at the time of manufacture and was then labeled
and distributed with the incorrect size information. A Cemented Trapezoid Tibial
Tray labeled as 4F/4T appeared to dimensionally be a 3F/3T.
VOLUME OF PRODUCT IN COMMERCE
21.
DISTRIBUTION
NJ, FL, MN, NY, MD, TX and the UK.
PRODUCT
Sunsoft Multiples Toric, methafilcon A, clear contact lens.
CODE
Lot Number 12981729.
RECALLING FIRM/MANUFACTURER
Ocular Sciences, Inc. Albuquerque, NM.
REASON
Vials containing the lenses are possibly contaminated with residual hydrogen
peroxide.
VOLUME OF PRODUCT IN COMMERCE
46 lenses.
DISTRIBUTION
Nationwide.
PRODUCT
a) Amplatzer Delivery Systems (45-degree curve).
order no. 9-DEL-6F-45/60. Product is labeled
as Sterile EO. Amplatzer Occluder Device and
Delivery System is comprised of delivery
sheath, delivery cable, dilator, loading
device and pin vise.
b) AMPLATZER Delivery System 45-degree curve,
order no. 9-DEL-7F-45/60. Product is
labeled as Sterile EO. Amplatzer Occluder
Device and Delivery System is comprised of
delivery sheath, delivery cable, dilator,
loading device and pin vise.
c) AMPLATZER Delivery System 45-degree curve,
order no. 9-DEL-7F-45/80. Product is
labeled as Sterile EO. Amplatzer Occluder
Device and Delivery System is comprised
of delivery sheath, delivery cable,
dilator, loading device and pin vise.
d) AMPLATZER Delivery System 45-degree
curve, order no. 9-DEL-8F-45/60.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin vise.
e) AMPLATZER Delivery System 45-degree
curve, order no. 9-DEL-8F-45/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised
of delivery sheath, delivery
cable, dilator, loading device
and pin vise.
f) AMPLATZER Delivery System 45-degree
curve, order no. 9-DEL-9F-45/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin
vise.
g) AMPLATZER Delivery System 45-degree
curve, order no. 9-DEL-10F-45/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin
vise.
h) AMPLATZER Delivery System 45-degree
curve, order no. 9-DEL-12F-45/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin
vise.
i) AMPLATZER Delivery System 180-degree
curve, order no. 9-DEL-5F-180/60.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin
vise.
j) AMPLATZER Delivery System 180-degree
curve, order no. 9-DEL-6F-180/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised
of delivery sheath, delivery cable,
dilator, loading device and pin vise.
k) AMPLATZER Delivery System 180-degree
curve, order no. 9-DEL-7F-180/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised
of delivery sheath, delivery
cable, dilator, loading device
and pin vise.
l) AMPLATZER Delivery System 180-degree
curve, order no. 9-DEL-8F-180/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin vise.
m) AMPLATZER Delivery System 180-degree
curve, order no. 9-DEL-9F-180/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin
vise.
n) AMPLATZER Exchange System 45-degree
curve, order no. 9-EXCH-9F-45/80.
Product is labeled as Sterile EO.
The AMPLATZER Exchange System is
comprised of the identical components
as the AMPLATZER Delivery System,
which is comprised of delivery
sheath, delivery cable, dilator,
loading device and pin vise.
The only exception is the dilator
component in the Exchange System
has a larger inner lumen to allow
passage over an AMPLATZER delivery
cable. ;
o) AMPLATZER Exchange System 45-degree
curve, order no. 9-EXCH-12F-45/80.
Product is labeled as Sterile EO.
The AMPLATZER Exchange System is
comprised of the identical components
as the AMPLATZER Delivery System,
which is comprised of delivery sheath,
delivery cable, dilator, loading
device and pin vise. The only
exception is the dilator component
in the Exchange System has a larger
inner lumen to allow passage over
an AMPLATZER delivery cable.
p) AMPLATZER Exchange System 180-degree
curve, order no. 9-EXCH-6F-180/80.
Product is labeled as Sterile EO.
The AMPLATZER Exchange System is
comprised of the identical components
as the AMPLATZER Delivery System,
which is comprised of delivery
sheath, delivery cable, dilator,
loading device and pin vise.
The only exception is the dilator
component in the Exchange System
has a larger inner lumen to allow
passage over an AMPLATZER delivery
cable.
q) AMPLATZER Exchange System 180-degree
curve, order no. 9-EXCH-8F-180/80.
Product is labeled as Sterile EO.
The AMPLATZER Exchange System
is comprised of the identical
components as the AMPLATZER
Delivery System, which is
comprised of delivery sheath,
delivery cable, dilator, loading
device and pin vise. The only
exception is the dilator component
in the Exchange System has a larger
inner lumen to allow passage over
an AMPLATZER delivery cable.
CODE
a) 00E01-13, M02K07-44, M03C24-17,
M03E27-07, M03F18-09, M03L11-45,
M04B09-16, M04E27-19;
b) M01J08-12, M02D26-01, M02L11-20,
M03A09-12, M03B20-12, M03D16-24,
M03F18-08, M03L12-09, M04C23-09,
M04G01-24;
c) M01K01-6, M02C12-24, M02C25-15,
M02F05-23, M02F24-05, M02L02-21,
M03A09-10, M03A09-15, M03A20-10,
M03B20-17 M03C24-14, M03F02-17,
M03G23-08, M03H12-42, M03J19-07
M03K14-06, M03K28-35, M03L11-48,
M04B03-09, M04B03-14 M04C08-12,
M04D06-12, M04E11-28, M04E24-20,
M04F08-23 M04H03-23, M04J17-07,
M04K07-02;
d) M02D26-02, M02I23-02, M02J10-09,
M02K07-47, M03C04-06 M03D16-16,
M03F18-07, M03K14-07, M03L18-50,
M03M03-11 M04C23-10, M04E24-18,
M04G01-20;
e) M01J19-12, M02B14-10, M02C12-27,
M02D16-19, M02D16-23 M02F24-07,
M02G23-04, M02H19-05, M02K07-48,
M02K12-10 M02L11-13, M03A09-13,
M03A20-11, M03A20-18, M03A22-12,
M03B10-56, M03B20-11, M03C24-13,
M03D08-08, M03D16-18 M03E27-08,
M03F13-07, M03F18-10, M03H12-43,
M03J04-12, M03J19-08, M03J25-27,
M03K09-23, M03K28-36, M03L11-46,
M03M03-12, M03M29-07, M04A19-28,
M04A28-16, M04B03-13, M04B09-19,
M04B17-33, M04B24-08, M04C23-11,
M04D06-13 M04D26-06, M04D26-10,
M04F08-22, M04F28-47, M04H24-22,
M04J07-09, M04J10-22, M04J17-08,
M04K15-10, M04L02-02;
f) M01K01-7, M01K28-18, M02C25-24,
M02D16-17, M02D16-21, M02E16-28,
M02F05-22, M02F24-08, M02G23-01,
M02G23-06, M02K07-51, M02K12-09,
M02K20-06, M02K25-13, M02L02-29,
M02L11-10, M02L11-15, M02L11-17,
M03A09-70, M03A27-34, M03A27-35,
M03B10-52, M03B10-55, M03B20-19,
M03C13-11, M03C13-13 M03C24-11,
M03G09-13, M03G24-19, M03G30-26,
M03H01-02, M03H05-17, M03H05-18,
M03H12-40, M03H15-03, M03H15-05,
M03H15-09, M03J02-16, M03J10-08,
M03J10-09, M03K14-08, M03K24-15,
M03K28-37, M03M02-12, M03M03-08,
M03M29-03, M03M29-06, M03M30-13,
M04A19-29, M04A28-18, M04B03-12,
M04B17-38, M04C08-13, M04C15-04,
M04C15-06, M04D06-09, M04D13-17,
M04D20-08, M04D26-07, M04D26-09,
M04E24-19, M04E27-24, M04F21-43,
M04F23-23, M04G27-25, M04H12-12,
M04H24-20, M04L05-08;
g) M01I13-3, M02E14-03, M02E16-24,
M02E16-30, M02F05-20, M02G10-04,
M02G23-05, M02H19-01, M02H30-01,
M02K07-03, M02K12-07, M02L02-24,
M02L02-27, M02L11-11, M02L19-08,
M03A09-16, M03A22-11, M03B10-53,
M03F13-06, M03F19-13, M03G10-37,
M03H08-06, M03H15-07, M03J04-05,
M03J17-05, M03J25-26, M03K01-02,
M03K09-22, M03K14-05, M03K16-16,
M03K16-17, M03K24-09, M03L18-56,
M03M30-11, M03M30-14, M03M30-15,
M04A19-30, M04B03-11, M04B17-34,
M04B24-09, M04C30-08, M04F08-20,
M04F23-20, M04F28-46, M04G01-19,
M04G01-21, M04H23-20, M04H23-21,
M04J07-04;
h) M01K01-1, M02D16-22, M02E16-25,
M02E16-29, M02G10-03, M02H30-02,
M02K07-37, M02K12-08, M02K20-08,
M02L02-28 M02L11-12, M02L19-07,
M03A09-17, M03A20-12, M03A22-14,
M03B20-16, M03C04-05, M03D16-14,
M03G09-07, M03G10-36, M03H15-12,
M03H15-13, M03J12-02, M03J25-28,
M03K16-21, M03K24-13, M03L18-55,
M03M03-13, M03M30-12, M03M30-16,
M04A28-19, M04C09-03, M04C09-04,
M04C15-05, M04D01-04, M04D06-08,
M04D26-08, M04F21-42, M04F23-22,
M04G27-26 M04H03-22, M04H24-21;
i) M02A28-23, M03A09-11, M03B20-15,
M03H06-07, M03J19-05, M03L18-49,
M04B02-02, M04C01-19, M04E18-13,
M04J13-15;
j) M01B01-14, M01G05-7, M02A02-33,
M02A28-20, M02C12-26, M02D26-03,
M02D26-05, M02I23-01, M02K07-42,
M03A09-14, M03A20-13, M03A22-09,
M03B20-14, M03C24-15, M03D02-05,
M03D02-07, M03D08-10, M03D16-23,
M03D16-25, M03K16-22, M03K28-33,
M03L11-47, M03M02-09, M03M03-09,
M03M12-18, M04A19-31, M04B03-10,
M04C01-17,M04C23-12, M04D06-10,
M04D13-16, M04E24-16, M04F23-21,
M04F28-40, M04G01-22, M04G27-27,
M04H03-17, M04H12-11;
k) 00L14-6, M01K28-17, M01L17-06,
M02D16-18, M02D26-04, M02I13-02,
M02K07-04, M02K07-45, M02K12-11,
M03A22-13, M03C24-10, M03D02-06,
M03D02-08, M03D16-17, M03G10-31,
M03G15-34, M03K24-14, M03L12-10,
M03M12-19, M04B03-08, M04B09-17,
M04C01-18, M04D01-05, M04D06-11,
M04D20-07, M04E04-05, M04F08-21,
M04H03-18, M04H24-25;
l) M01L17-02, M02A28-21, M02A28-24,
M02K07-46, M03G10-30, M03L18-52,
M04B09-18, M04C23-13, M04E27-20,
M04F08-24, M04H03-20, M04K26-18;
m) M02A28-22, M02B25-05, M02B25-06,
M03C24-12, M03K28-34, M03L18-51;
n) M01L12-10, M03D08-06, M03D08-07,
M03L18-54;
o) M01B14-8, M02F05-18, M03A09-69,
M03E27-05, M03F18-12;
p) M02B14-09, M02C25-16;
q) M02A28-25, M04D01-06.
RECALLING FIRM/MANUFACTURER
AGA Medical Corporation, Golden Valley, MN.
REASON
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System
sheaths was in some cases manufactured by our supplier outside of process parameters;
causing a residue to be left on the inside of the tubing. Residue was determined
to be EAP (Ethoxylated alkyl Phenol).
VOLUME OF PRODUCT IN COMMERCE
65,675 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
System 1000 family of Hemodialysis Instruments, including the System 1000, Arena,
1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL
60015 U.S.A.
CODE
System 1000: serial numbers 1001S-1142S, 50001-52109, 01001-22223 Arena: serial
numbers 300001-300640 1550: serial numbers 52599-67210 BM11: all serial numbers
BM25: all serial numbers Meridian: serial numbers 200101-203156.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div, Mc Gaw Park, IL.
REASON
Air bubbles have been observed in the tubing sets past the air detector of the
instrument with no alarms. Air bubbles in the circuit can cause an air embolism.
VOLUME OF PRODUCT IN COMMERCE
2240.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Thoravision I Thorax and Mass Chest
Column. Part numbers 4512 130 07811.
b) Thoravision II Thorax and Mass Chest
Column. Part numbers 4512 130 07812.
CODE
a) The firm uses site numbers instead of
serial numbers. The listed site numbers
include both Thoravision I and II
products. 83956, 13253, 13917, 86223,
25709, 38975, 17579, 13610, 17506, 50321,
100322, 13919, 45032, 44803, 26294, 82617,
76802, 100633, 41354, 26058, 100693,
76806, X0212, 62971, 76374, 59408, 6960,
38715, 10405, 40932, 50319, 50320, 59670,
62972, 86451, X1068, 47101, 47167, 17620,
26214, 76020, 76021, 41437, 38989;
b) See the site numbers listed for the
Thoravision I. The listed site numbers
include both Thoravision I and II products.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales & Service Region No. America, Bothell, WA.
REASON
X-Ray system may fall downward and could possibly hit the patient.
VOLUME OF PRODUCT IN COMMERCE
44 total units (Thoravision I and II).
DISTRIBUTION
Nationwide.
PRODUCT
UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels). Part Number: 386167.
CODE
Lot Number: 04250160.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc, Brea, CA.
REASON
Beckman Coulter has confirmed reports of rare occurrences of UniCel Dxl 800
Access Immunoassay Systems Reaction Vessels that are deformed or flattened in
their packaging bags for lot 04250160. Deformed or flattened RVs could present
a rish of causing jams on the UniCel Exl 800 Access Immunoassay Systems that
may require service intervention and could compromise sample analysis.
VOLUME OF PRODUCT IN COMMERCE
56 boxes.
DISTRIBUTION
Nationwide, and Canada.
PRODUCT
ACCU-CHEK Inform meter; catalog No. 3035123.
CODE
All units with firmware version 2.3 that have the OTE (other test entry) functionality
enabled.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp. Indianapolis, IN.
REASON
A firmware bug may allow test results from other systems, recorded into the
INFORM system via the OTE functionality, to be reversed from positive to negative,
and vice versa.
VOLUME OF PRODUCT IN COMMERCE
4697.
DISTRIBUTION
Nationwide.
PRODUCT
StreamLab Analytical Workcell. General Purpose Laboratory Device.
CODE
Software version 3.5.
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE.
REASON
Software can sample the incorrect specimen from the StreamLAB to the Dimension
RxL or RxL Max Systems.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
IL, MD, NJ, OH, VA, Italy, Spain, and Portugal.
PRODUCT
a) BD, Brucella melitensis Antigen.
b) BD, Salmonella O Group D Antigen (9-12) (Typhoid O).
c) BD, Salmonella Somatic Polyvalent Antiserum (A,B,D).
d) BD, Brucella abortus Antigen.
e) BD, Salmonella Flagellar d Antigen (Typhoid H).
f) BD, Salmonella O Group A Antigen (1-2-12).
g) BD, Salmonella O Group B Antigen (1-4-5-12).
h) BD, Salmonella Flagellar Polyvalent Antiserum (a,b,d).
i) BD, Proteus OX19 Antigen.
j) BD, Francisella tularensis Antigen.
k) BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19).
l) BD, Brucella Postive Control Antiserum (AMS).
m) BD, Febrile Antigen Negative Control.
CODE
a) Catalogue #240943, Lot #3046337;
b) Catalogue #24074, Lot #2119981;
c) Catalogue #240941, Lot #3093814;
d) Catalogue #241049, Lot #2192837, 3029141,
2116596, 3029124 & 2092005;
e) Catalogue #240785, Lot #2192844 & Lot # 2270533;
f) Catalogue #240731, Lot #3072592, 3126311;
g) Catalogue #240732, Lot #3072597 & Lot #3121355;
h) Catalogue #240942, Lot #3029192;
i) Catalogue #240782, Lot #3035884;
j) Catalogue #241050, Lot #2289707,
2191842 & 166779;
k) Catalogue #240490, Lot #3079439;
l) Catalogue #240934, Lot #3210932;
m) Catalogue #240937, Lot #3093813.
RECALLING FIRM/MANUFACTURER
BD Diagnostic Systems, Grayson, GA.
REASON
Febrile Antigens and Control Antisera that were released prior to August 2003
contained the 12/2000 revised insert that had incorrect testing instructions.
The Antigen Dilution instructions incorrectly state to dilute "one part antigen
in fifty parts 0.85% saline (1:50)". The correct instructions should read "one
part antigen in forty-nine parts 0.85% saline (1:50)".
VOLUME OF PRODUCT IN COMMERCE
6,946 vials.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Immulite 2500 insulin Kit.
CODE
Lot 102A.
RECALLING FIRM/MANUFACTURER
Diagnostic Products Corp, Los Angeles, CA.
REASON
Low bias of 10 to 40% at different levels of insulin in samples.
VOLUME OF PRODUCT IN COMMERCE
10 kits.
DISTRIBUTION
AK, NY, and WI.
PRODUCT
The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay
for the qualitative detection of Treponema pallidum IgG antibodies in human
serum or plasma. The reagents can be used either manually or in conjunction
with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared
this product for use in screening blood or plasma donors. The kit is labeled
with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade.
The non conforming kit component is the Conjugate that consists of a glass bottle
with red cap containing 30 ml goat anti-human IgG labeled with horseradish
peroxidase.
CODE
The kit lot number is 42003. The conjugate lot number is 42023.
RECALLING FIRM/MANUFACTURER
Diamedix Corporation, Miami, FL.
REASON
Several customers complained that either the negative control index value exceeded
the upper control limit or there was very low activity of the cut off calibrator
causing patient sample test runs to be called invalid.
VOLUME OF PRODUCT IN COMMERCE
265 kits.
DISTRIBUTION
Nationwide.
PRODUCT
McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage,
single patient use, knit, single self closure, latex-free; Made in Canada, Packaged,
sterilized and inspected in the U.S.A.; the elastic bandages are packaged in
paper/poly pouches, 36 bandages per case in the following sizes: Product Number
16-1033-2-STR, 2" wide; 16-1033-3-STR, 3" wide; 16-1033-4-STR, 4" wide; and
16-1033-6-STR, 6" wide.
CODE
Lot numbers 3001 through 40999.
RECALLING FIRM/MANUFACTURER
Cypress Medical Products, Ltd., McHenry, IL.
REASON
The elastic bandages which are labeled sterile have a lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
17,964 units.
DISTRIBUTION
Nationwide.
WEEK ENDING JANUARY 22
PRODUCT
NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter.
Product is shipped in cases of 5 units. Catalog numbers S1PIC1-9-S, S1PIC1.9-N,
S1PIC1.9-SMK, and S1PIC1.9-C.
CODE
All lots higher than number 3231.
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Reading, PA.
REASON
Complaints of vessel erosion when using this product.
VOLUME OF PRODUCT IN COMMERCE
36,340 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Spinbrush Pro Whitening Ex Soft battery operated
toothbrush, UPC 7 66878 00191 3.
b) Spinbrush Pro Whitening Medium battery operated
toothbrush, UPC 7 66878 00193 7.
c) Spinbrush Pro Whitening Ex Soft refill heads for
battery powered toothbrushs, UPC 7 66878 00192 0.
d) Spinbrush Pro Whitening Medium refill heads for
battery powered toothbrushs, UPC 7 66878 00194 4.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Proctor & Gamble Co, Cincinnati, OH.
REASON
Market withdrawal of Crest Spinbrush Pro-Whitening. The firm has determined
that there is a quality issue in certain production that may allow the circular
brush at the tip of the brush head to become detached over time in a very small
number of brushes.
VOLUME OF PRODUCT IN COMMERCE
7.5 million toothbrushes.
DISTRIBUTION
Nationwide.
PRODUCT
Mammo Test Breast Biopsy System.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Fischer Imaging Corp., Denver, Co.
REASON
X-ray tube actuator shaft may fail, allowing the mechanism to drop without
warning.
VOLUME OF PRODUCT IN COMMERCE
1,081 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Victory Motorized Vehicle, 3 wheel.
b) Victory Motorized Vehicle, 4 wheels.
CODE
a) Model number SC1600;
b) Model number SC1700.
RECALLING FIRM/MANUFACTURER
Pride Mobility Product Corp., Exeter, PA.
REASON
Intermittent operation.
VOLUME OF PRODUCT IN COMMERCE
17,000 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh
Nebulizer,
Model NE-U22V/NE-22VAC.
CODE
Bottle lots 43A, 53A, 63A, 73A, 83A, 93A, X3A, Y3A and Z3A, a component of
Nebulizer model NE-U22 serial numbers 34300001A and highter, 3500001A and higher,
3600001A and higher, 3700001A and higher, 3800001A and higher, 3900001A and
higher, 3X00001A and higher, 3Y00001A and higher, and 3Z00001A through 3Z00696A.
Medication bottles with either a blue dot or a blue O-ring were manufactured
after corrections were made and are not subject to the recall.
RECALLING FIRM/MANUFACTURER
Omron Healthcare, Inc., Bannockburn, IL.
REASON
A potential failure of the vibrating mechanism of the medication bottle which
causes a failure to transmit vibration and results in no nebulization.
VOLUME OF PRODUCT IN COMMERCE
63,560 units.
DISTRIBUTION
Nationwide.
PRODUCT
Roche brand Cardiac Reader.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN.
REASON
Potential for false negative Troponin T or falsely decreased Troponin T and
Myoglobin results.
VOLUME OF PRODUCT IN COMMERCE
128 units.
DISTRIBUTION
Nationwide.
PRODUCT
Ultrasound Probe Drape Tapered to 1.5’ Sterile 8’ x 60’,
Product Number 781-983.
CODE
Lot Number A 7611.
RECALLING FIRM/MANUFACTURER
Hydro Med Products, Inc., Dallas, TX.
REASON
Defective packaging, potential for breech in sterility.
VOLUME OF PRODUCT IN COMMERCE
35 cases/10 units per case.
DISTRIBUTION
Nationwide.
PRODUCT
Baxter labeled 6060 Solution Sets with AutoClamp;
For use with model 6060 multi-therapy pumps only;
a prescription, sterile, non-pyrogenic fluid pathway;
A) the following sets were made in Costa Rica:
a) Baxter Solution Set, 76” (1.9 m), Volume 3.7 mL,
Cassette with AutoClamp Device, Male Luer Lock
Adapter, product code 2M9856 and 2M9856K;
b) Baxter Solution Set, 109” (2.8 m), Volume 4.8 mL,
Cassette with AutoClamp Device, Male Luer Lock
Adapter, product code 2M9857;
c) Baxter Solution Set, 112” (2.9 m), Volume 7.9 mL,
Cassette with AutoClamp Device, 1.2 Micron
Downstream Filter, Male Luer Lock Adapter,
product code 2M9858 and 2M9858K;
d) Baxter Solution Set, 112” (2.9 m), Volume 7.9 mL,
Cassette with AutoClamp Device, 0.22 Micron
Downstream Filter, Male Luer Lock Adapter,
product code 2M9859;
e) Baxter Solution Set, 76” (1.9 m), Volume 3.7 mL, Non-DEHP Tubing, Cassette with AutoClamp Device,
Male Luer Lock Adapter, product code 2M9860;
f) Baxter Solution Set, 112” (7.9 m), Volume 3.7 mL, Non-DEHP Tubing, Cassette with AutoClamp Device,
1.2 Micron Downstream Filter, Male Luer Lock
Adapter, product code 2M9861;
g) Baxter Solution Set, 112” (7.9 m), Volume 3.7 mL, Non-DEHP Tubing, Cassette with AutoClamp Device,
0.22 Micron Downstream Filter, Male Luer Lock
Adapter, product code 2M9862;
h) Baxter Solution Set, 111” (2.9 m), Volume 7.4 mL,
Cassette with AutoClamp Device, 1.2 Micron
Downstream Filter, Male Luer Lock Adapters,
product code 2M9874K;
i) Baxter Solution Set, 75” (1.9 m), Volume 3.1 mL,
Cassette with AutoClamp Device, Male Luer Lock
Adapters, product code 2M9875K;
j) Baxter Epidural Set, 115” (2.9 m), Volume 5.0 mL,
Cassette with AutoClamp Device, Male Luer Lock
Adapter, product code 2L9003;
k) Baxter Epidural Set, 112” (2.9 m), Volume 7.9 mL,
Cassette with AutoClamp Device, 0.22 Micron
Downstream Filter, Male Luer Lock Adapter, product
code 2L9004;
l) Baxter Epidural Set, 92” (2.3 m), Volume 6.7 mL,
Cassette with AutoClamp Device, 0.22 Micron
Downstream Filter, Male Luer Lock Adapters,
product code 2L9005;
m) Baxter Solution Set with Spike, 88” (2.2 m),
Volume 4.1 mL, Non-DEHP Tubing, Cassette with
AutoClamp Device, Male Luer Lock Adapter,
product code 2L9006.
B) Sabraset Administration Sets with AutoClamp;
for use with model 6060 multi-therapy pumps only;
a prescription, sterile, non-pyrogenic fluid pathway;
the following sets were made in Mexico:
a) Sabraset 56050 – 100 Administration Set with
100 mL Bag and Cassette, 56”, Volume 3 mL,
100 mL Bag with Fill Port, Cassette with
AutoClamp Device, Slide Clamp, Male Luer Lock
Adapter;
b) Sabraset 56050 – 250 Administration Set with
2500 mL Bag and Cassette, 53”, Volume 3 mL,
250 mL Bag with Fill Port, Cassette with
AutoClamp Device, Slide Clamp, Male Luer Lock
Adapter.
CODE
A) Product codes 2M9859, 2M9856, 2M9856K, 2M9857,
2M9858, 2M9858K, 2M9860, 2M9861, 2M9862, 2M9874K,
2M9875K, 2L9003, 2L9004, 2L9005, 2L9006;
all sets with lot numbers below R03K25200.
The lot number R03XXXXXX (format RYYMDDNNC) is
broken down as follows: R = manufacturing plant
location; YY = numeric year (01, 02, 03);
M = alpha month, A = January through L = December;
DD = numeric day of month; NN = numeric batch
number for the day, 01 - 99; C = numeric check
digit generated by computer;
B) Product codes 560500-100 and 560500-250,
all lot numbers other than lots produced
within the range of 417519 to 499999, or
those with an adhesive circular colored
sticker (Avery dot) at the top of the
individual package on the Tyvek side or on
the shipper label. Any lot numbers from the
following obsolete Sabraset product codes
are also being recalled: 5600PM, 560100,
560101, 560110, 560111, 560112, 560112-GEL,
560112-L, 560113, 560115, 560116, 560122-L,
561101, 567100, 567100-L, 567112-L, 567122-L,
569100, 569111, 569122, 560200-100, 560522-100.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp, Round Lake, IL.
REASON
A missing platen assembly in the cassette of the solution sets results in the
infusion pump being unable to occlude the tubing of the set. This can lead
to free-flow of the solution and a possible overdose of medication to the patient.
VOLUME OF PRODUCT IN COMMERCE
4,419,179 sets.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Zimmer™ Orthopaedic Surgical Products,
Disposable Cuff, 42in (107cm), Single Port,
Single Bladder Sterile. The cuff is a sterile,
single use product equipped with an integral
fill line. The product is packed 10 cuffs
per unit. Cat #60-7075-007-00.
b) Zimmer™ Orthopaedic Surgical Products,
Disposable Cuff, 12” (30cm), Single Port,
Single Bladder Sterile. The cuff is a sterile,
single use product equipped with an integral
fill line. The product is packed 10 cuffs
per unit. Cat #60-7075-002-00.
c) Zimmer™ Orthopaedic Surgical Products,
Disposable Cuff, 12” (30cm), Dual Port,
Single Bladder Sterile. The cuff is a sterile,
single use product equipped with an integral
fill line. The product is packed 10 cuffs
per unit. Cat #60-7070-002-00.
CODE
a) Lot #60171355;
b) Lot #60153745;
c) Lot #60156865.
RECALLING FIRM/MANUFACTURER
Zimmer Orthopaedic Surgical Products, Statesville, NC.
REASON
The port/tube bond in the affected cuffs may separate during surgery causing
the pressure in the cuff to release.
VOLUME OF PRODUCT IN COMMERCE
235 units (10 cuffs per unit).
DISTRIBUTION
Nationwide, Australia, Demark, and Germany.
PRODUCT
Vitros CRP (C-Reactive Protein) Slides. Catalog # 1926740 contains 250 slides,
Catalog #809 7990 contains 90 slides.
CODE
Coatings 401 thru 419.
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY.
REASON
Results may be negatively biased due to a non-linear response at the upper
end of the Reportable (Dynamic) Range.
VOLUME OF PRODUCT IN COMMERCE
55,780 boxes.
DISTRIBUTION
Nationwide and Internationally.