MAY 2004

WEEK ENDING MAY 1


PRODUCT
a) Medtronic Micro Jewel II Implantable Cardioverter Defibrillators, Model 7223Cx.
b) Medtronic GEM DR Implantable Cardioverter Defibrillators, Model 7271. .
CODE
a) Manufacturing dates from November 1996 to December 1997; and Use Before Dates from May 1998 to June 1999;
b) Manufacturing Dates from May 1997 to August 1998; and Use Before Dates from November 1998 to February 2000.
RECALLING FIRM/MANUFACTURER Medtronic Inc., Cardiac Rhythm Management, Fridley, MN.
REASON Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive conditions as the battery voltage nears the level for Elective Replacement of the devices.
VOLUME OF PRODUCT IN COMMERCE 6,200 defibrillators.
DISTRIBUTION Nationwide and Internationally.


PRODUCT DUO Laser System, Class IV laser diode material processing machine. 
CODE Not supplied.
RECALLING FIRM/MANUFACTURER Coherent, Inc., Santa Clara, CA.
REASON Unintended emission of laser radiation.
VOLUME OF PRODUCT IN COMMERCE 95.
DISTRIBUTION Nationwide.


PRODUCT
a) Stat Profile Critical Care Xpress (CCX) Analyzer. Catalog Number: 35942.
b) Stat Profile Critical Care Xpress CCX+ Analyzer. Catalog Number: 37413.
c) Stat Profile Critical Care Xpress CCX (R) Analyzer. Catalog Number: 37562 R=Refurbished.
d) Stat Profile Critical Care Xpress CCX+(R) Analyzer. Catalog Number: 37555 R=Refurbished.
e) ABG Replacement Pump Assembly Catalog Number: 37092.
CODE
a) Domestic S/N: Y01C03200 Y01C03130 Y01104030 Y01104040 Y01104100 Y01104110 Y01304150 Y01304120 Y01104150 Y01104130 Y01104050 Y01104190 Y01104160 Y01104220 Y01204020 Y01204100 Y01204010 Y01204130 Y01204150 Y01204160 Y01703120 Y01304040 Y01304010 Y01304110

International S/N: Inst. S/N Y01204200 Y01304030 Y01304130 Y01304140 Y01304090 Y01304100 Y01104140
Y01204070 Y01204170 Y01104120 Y01C03150;
b) Domestic Serial Numbers: Y02C03170 Y02C03140 Y02C03180 Y02104060 Y02104180 Y02104070 Y02104210 Y02104080 Y02204180

International S/N: Y02204030 Y02204040 Y02204050 Y02204110 Y02204120 Y02204140 Y02204190
Y02304020 Y02C03190 Y02C03160 Y02C03090 Y02204060 Y02C03070 Y02304050 Y02C03050 Y02104090 Y02104230
Y02104170 Y02104020 Y02304070;
c) Serial Numbers: Inst. S/N Y01902211 Y01203021 Y01B02101;
d) Domestic S/N: Y02902141 Y0290211Z Y02103141 Y02303101 Y02503281

International S/N: Y02603111 Y02603091;
e) Devices shipped between March 30-31, 2004.
RECALLING FIRM/MANUFACTURER Nova Biomedical Corporation, Waltham, MA.
REASON Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems.
VOLUME OF PRODUCT IN COMMERCE 73 units.
DISTRIBUTION Nationwide and International.


PRODUCT
a) Henry Schein (r) Product Code/Mfr. Part Code 101-0913 Explorer #2 D/E. Made in China. For professional use
Only. Instruments must be cleaned and sterilized prior to use. This product is a dental explorer made of
stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k)
exempt, Class I device, Device Listing #B057701.
b) Henry Schein (r) Product Code/Mfr. Part Code 100-3620 Explorer-Single End #23 SE. Made in China. For
professional use only. Instruments must be cleaned and sterilized prior to use. This product is a dental
explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert
(labeling). 510 (k) exempt, Class I device, Device Listing #B057701.

c) Henry Schein (r) Product Code/Mfr. Part Code 100-8008 Explorer-Double End #5. Made in China. For professional Use only. Instruments must be cleaned and sterilized prior to use. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k)
exempt, Class I device, Device Listing #B057701.
CODE
a) Date Codes/Lot Numbers: 1102, 0103 (1102 represents November 2002, & 0103 represents January 2003);
b) Date Codes/Lot Numbers: 1102, 1202, 0103 (1102 represents November 2002, 1202 represents December 2002,
&& 0103 represents January 2003), Product Code/Mfr. Part Code 100-3620;
c) Date Codes/Lot Numbers: 0902, 1202, 0103 (0902 represents September 2002, 1202 represents December
2002, && 0103 represents January 2003), Product Code/Mfr. Part Code 100-8008.
RECALLING FIRM/MANUFACTURER Hu-Friedy Mfg., Co., Inc., Chicago, IL.
REASON The tips of the instruments may have been improperly heat treated and have the potential for unexpected tip fracture.
VOLUME OF PRODUCT IN COMMERCE 30,534 units.
DISTRIBUTION Nationwide and Internationally.


PRODUCT Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications. 
CODE Model 744000.
RECALLING FIRM/MANUFACTURER Gyrus Medical, Inc., Maple Grove, MN.
REASON The generator may malfunction when used in close proximity to a monopolar generator.
VOLUME OF PRODUCT IN COMMERCE 14.
DISTRIBUTION Nationwide.


PRODUCT Boston Scientific MEDI-TECH***VASCULAR DILATOR***Order No./REF:48-151 M001481510, 5 Fr. Product in clear plastic pouch.
CODE 929123, Exp. 12/2006.
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Glens Falls, NY.
REASON Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr.
VOLUME OF PRODUCT IN COMMERCE 43 units.
DISTRIBUTION Nationwide.


PRODUCT
a) Suction Instrument with Tubing, Catalog No. 302. Instrument: Yankauer without Vent. *Tubing: 6" x 1/4" I.D.
Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. Packaged and Sterilized in the U.S.A. *Tubing Made
in Mexico. Classification Name: Unit, Suction Operatory. Class I device, 510(k) exempt, Device Listing Number
A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.
b) Suction Instrument with Tubing, Catalog No. 303. Instrument: Yankauer with Vent. *Tubing: 6" x 1/4" I.D.
Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. *Tubing Made in Mexico. Classification Name:
Unit, Suction Operatory. Class I device, 510 (k) exempt, Device Listing Number A715729. Product comprises 2
components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible
packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.
c) Suction Instrument with Tubing, Catalog No. 305. Instrument: Yankauer without Vent. *Tubing: 10" x 1/4"
I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. Classification Name: Unit, Suction Operatory.
Class I device, 510 (k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.
CODE
a) Lots: 0020404, 0020421, 0020539, 0020567, 0020578, 0020578, 0020641, 0020933, 0020982, 0021060, 0021067,
0021262, 0021366, 0022027, 0120089, 0120146, 0120217, 0120285, 0120342, 0120427, 0120491, 0120626, 0120697,
0120753, 0120866, 0120968, 0121063, 0121172, 0121403, 0220079, 0220201, 0220305, 0220348, 0220424, 0220474,
0220509, 0220522, 0220673, 0220683, 0220847, 0220927, 0220956, 0320185, 0320194, 0320208, 0320243, 0320267,
0320335, 0320343, 0320391, 0320392, 0320412, 0320438, 0320438, 0320485, 0320504, 0320536, 0320558, 0320582,
0320609, 0320642;
b) Lots: 0020337, 0020564, 0020577, 0020642, 0020897, 0020961, 0020986, 0021349, 0021367, 0021414, 0120065,
0120218, 0120394, 0121062, 0121169, 0121225, 0121414, 0220162, 0220213, 0220436, 0220510, 0220596, 0220970,
0221058, 0320169, 0320180, 0320205, 0320410, 0320660, 0321116, 0321180, 0321204;
c) Lots: 0020491, 0020510, 0020607, 0021386, 0120147, 0120211, 0120265, 0120377, 0120585, 0120904, 0121194,
0121312, 0220006, 0220200, 0220302, 0220550, 0220779, 0220925, 0221006, 0320104, 0320179, 0320230, 0320408,
0320556, 0320680, 0320973.
RECALLING FIRM/MANUFACTURER Busse Hospital Disposables, Hauppauge, NY.
REASON Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a slower rate of suction.
VOLUME OF PRODUCT IN COMMERCE 292,840 units.
DISTRIBUTION Nationwide and Internationally.


PRODUCT ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT C8000 Processing Module.
CODE The RS-232 Manual is not controlled by control or lot numbers.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX.
REASON When using a LIS the software system will send up a test result of up to 20 characters although the field is set to display only 15 characters per the RS-232 Manual.
VOLUME OF PRODUCT IN COMMERCE 101.
DISTRIBUTION Nationwide and Internationally.


PRODUCT AEROSET Analyzer System, Model 9D05-01.
CODE All Serial Numbers.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX.
REASON Change of level 3 error log messages to level 1 to prevent suspect assay results.
VOLUME OF PRODUCT IN COMMERCE 656 systems.
DISTRIBUTION Nationwide and Internationally.

 

WEEK ENDING MAY 8


PRODUCT Axiom Artis System.
CODE Part numbers 5904433, 5904649, 5904466, 5904441, 5904656, and 7007755. Serial numbers 10070, 10075, 10076, 10101, 10138, 10148, 10240, 10241, 10248, 10251, 10255, 10257, 10261, 10263, 10266, 14068, 20015, 20129, 20136, 25092, 25112, 25134, 25135, 25148, 25156, 25157, 25159, 25160, 25163, 25169, 25170, 28008, 28015, 28019, 28046, 28047, 28049, 28053, 28058, 28059, 28061, 32004, 32013, 32017, and 32019.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA.
REASON Patient images misidentified.
VOLUME OF PRODUCT IN COMMERCE 46 units.
DISTRIBUTION Nationwide.


PRODUCT Prima IIITotal SENSE Torso Coil (Body Array Coil), a Magnetic Imaging Accessory. This device is a component of the Magnetom TRIO 3.OT MRI Systems. 
CODE USAI P/N: 100352, USAI S/Ns: 310 to 388 (Rev 1 and 2); Siemens P/N: 7578789, Siemens S/Ns: 1010 to 1088.
RECALLING FIRM/MANUFACTURER USA Instruments, Inc., Aurora, OH.
REASON A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's skin.
VOLUME OF PRODUCT IN COMMERCE 79 units.
DISTRIBUTION Nationwide and Internationally.


PRODUCT
a) GE Single 15 inch TV Monitor Suspension with Rail, Model 46-240485P1, Catalog number B0256EH. 
b) GE Single 15 inch TV Monitor Suspension for XT Bridge, Model 46-240485P2, Catalog Number B2056HA.

c) GE Single 20 inch TV Monitor Suspension with Rail, Model 46-240485P5, Catalog Number B2056EC.
d) GE Single 20 inch TV Monitor Suspension for XT Bridge, Model 46-240485P6, Catalog Number B2056EG.
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER General Electric Med Systems, Waukesha, WI.
REASON The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
VOLUME OF PRODUCT IN COMMERCE 1,236 units.
DISTRIBUTION Nationwide and Internationally.


PRODUCT
a) CryoValve Aortic Valve. Donor #71893, Model #AV00.
b) CryoValve Conduit and Pulmonary Valve and Conduit. Donor #71899, Model #PV00.

CODE
a) Serial # 8079912;
b) Serial # 8080113.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON A retrospective review of donor files conducted by CryoLife revealed an expired solution had been used during processing of the associated tissues.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.


PRODUCT
a) Port-A-Cath II Low Profile Epidural Implantable Access System, with PolyFlow Polyurethane Catheter, 1.2mm O.D. x 0.5mm I.D., REF 21-1501-01.
b) Port-A-Cath II Epidural Low Profile Polysulfone/Titanium Access System, with PolyFlow Polyurethane Catheter,1.2mm O.D. x 5mm I.D., REF 21-1501-22.
c) 6 Fr Introducer Set, REF 21-2320-24.
d) 9 Fr Introducer Set, REF 21-2340-24. 
e) 8.5 Fr Introducer Set, REF 21-2370-24. 
f) Port-A-Cath Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4003-24.
g) Port-A-Cath Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4009-24
h) Port-A-Cath Low Profile Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set, REF 21-4035-24.

i) Port-A-Cath Low Profile Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4037-24.
j) Port-A-Cath II Polysulfone/Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D.,
9 Fr Introducer Set, REF 21-4051-24.
k) Port-A-Cath II Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4055-24.
l) Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4071-24.
m) Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4073-24.
n) Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4083-24.
o) Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4085-24.
p) ProPort Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5
French Introducer Set, REF 21-4155-24.
q) ProPort Plastic Venous Access System, Pre-assembled wit PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4165-24.
r) ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4171-24.

s) ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 French Introducer Set, REF 21-4183-24.
t) Port-A-Cath P.A.S. Port T2 Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 French Introducer Set, REF 21-4573-24.
u) Port-A-Cath II Fluoro-Free Low Profile Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., and with CATH-FINDER Sensor Wire, REF 21-4685-24. Recall # Z-0876-04;
v) Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual-
lumen PolyFlow Polyurethane Catheter, 2.2mm O.D. x 1.0mm I.D., 7 French Introducer Set, REF 21-8066-24.
w) Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual-
lumen PolyFlow Polyurethane Catheter, 3.2mm O.D. x 1.4mm I.D., 10 French Introducer Set, REF 21-8068-24. CODE
a) Lot M27052;
b) Lot M27037;
c) Lot M26890;
d) Lot M27142;
e) Lot M27129;
f) Lot M27043;
g) Lot M27134;
h) Lot M27051;
i) Lots M27118 and M27262;
j) Lots M26978 and M27138;
k) Lots M27038, M26962, and M27119;
l) Lots M26963, M27058, and M27120;
m) Lot M27131;
n) Lots M26971 and M27045;
o) Lot M26982;
p) Lot M27054;
q) Lot M27136;
r) Lot M27046;
s) Lot M27048;
t) Lot M27049;
u) Lot M27047;
v) Lot M26975 and M27127;
w) Lot M26983;
RECALLING FIRM/MANUFACTURER Deltec, Inc., Saint Paul, MN.
REASON Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
VOLUME OF PRODUCT IN COMMERCE 2,406 units (access ports or introducers).
DISTRIBUTION Nationwide and Internationally.


PRODUCT
a) Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151 and 2M8151K (United Kingdom); Made in Singapore; monochrome display screen.

b) Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153K (United Kingdom); Made in Singapore; monochrome display screen.

c) Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161; Made in Singapore; color display screen.
d) Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163; Made in Singapore; color display screen.
CODE
a) Product code 2M8151- serial numbers 12040343CS and above; Product code 2M8151K - serial numbers 13010001CK and above;
b) Product code 2M8153 - serial numbers 12110481CT and above; product code 2M8153K - serial numbers 12120001TK and above;
c) Product code 2M8161 - serial numbers 12020001CC and above;
d) Product code 2M8163 - serial numbers 12030001TC and above.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation, Round Lake, IL.
REASON Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.
VOLUME OF PRODUCT IN COMMERCE 195,216 pumps.
DISTRIBUTION Nationwide and Internationally.


PRODUCT LIFEPAK 500 automated external defibrillator. Part numbers 3005380-000 through 3005380-006 and 3005380-014.

CODE Serial numbers may be obtained from the firm or from Seattle District Recall Coordinator. All battery date codes prior to 0013.
RECALLING FIRM/MANUFACTURER Medtronic Physio Control Corp, Redmond, WA.
REASON Potential for batteries to malfunction due to battery cell rupture.
VOLUME OF PRODUCT IN COMMERCE 7,028 units.
DISTRIBUTION Nationwide and Internationally.


PRODUCT EZ-DOP, diagnostic ultrasound imaging system.
CODE Serial numbers LDP4 0024 through LDP4 390.
RECALLING FIRM/MANUFACTURER DWL Systems, Inc., Sterling, VA.
REASON A certain sequence of data entries on the keypad could cause the ultrasound medical device to display incorrect transmission power.
VOLUME OF PRODUCT IN COMMERCE 367 units.
DISTRIBUTION Nationwide and Internationally.

 

Product: PRECISE® RX Nitinol Stent Transhepatic Biliary System

Use: Biliary stents are permanently implanted flexible tubular devices intended for use to treat bile duct obstruction due to malignancies. They function to drain the biliary tract and to keep the bile duct open. Uses outside of the biliary tract, i.e., in the cardiovascular or other systems, have not been cleared by the FDA.

Recalling Firm: Cordis Corporation
14201 NW 60th Ave
Miami Lakes, FL 33014-2802

Reason for Recall: Some physicians use this device for vascular use. This use has not been cleared by the FDA. When used this way, air may be introduced into the patient via the stent system causing serious problems including coma, seizure and stroke. There have been nine patient injuries due to air embolism and seven incidents of malfunction in connection with the use of this system outside of its approved indications. Cordis is recalling its revised instructions for use and strongly recommends that physicians limit the use of the PRECISE RX Stent to FDA-approved uses only.

Public Contact: Hal Delgado, Executive Director, Quality Assurance

District: Florida

Comment: Physicians are informed in the current labeling warning statement that the “safety and effectiveness for use in the vascular system have not been established.” Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.

                For additional information on this product recall, see the Cordis Corporation press release at: http://www.cordis.com/active/crdus/en_US/html/cordis/downloads/press/
PreciseRX_IFU_Press_Release_050704.pdf

 

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Nationwide Voluntary Recall Issued for Tecan Clinical Workstation

 

Roche Diagnostics today announced two voluntarily initiated recalls to make field corrective actions for the Tecan Clinical Workstation (TCW) that is used with Roche Diagnostics Amplicor® CT/NG test for the detection of Chlamydia and gonorrhea.

 

Roche Diagnostics initiated a field corrective action that included notifying customers and asking them to perform a manual workaround until the software can be corrected. Roche Diagnostics is working directly with the U.S. Food and Drug Administration to ensure that all appropriate parties are notified.

 

On a separate matter, Roche Diagnostics also issued a field corrective action of the Tecan Clinical Workstation that is used with the Amplicor CT/NG test for the detection of Chlamydia and gonorrhea due to a purging issue with the Tecan software.

 

The manufacturer of the TCW, Tecan, notified Roche Diagnostics that if an operator of the TCW fails to purge the TCW's data management system on a regular basis, in accordance with the TCW's operating instructions, the TCW's software may mismatch sample results and sample identification. Again, to Roche Diagnostics' knowledge, in all reported cases the error was noticed before results were reported out and no patient results were adversely affected.

 

Roche Diagnostics initiated a field corrective action that included notifying customers and asking them to perform a purge of their data on a monthly basis.

 

All Tecan Clinical Workstations with Robonet software and that are used with the Roche Diagnostics Amplicor CT/NG assay are affected. Laboratories with questions can contact Roche Diagnostics at 1-800-526-1247.

 

Patients who are concerned about the results of a Chlamydia and gonorrhea test should consult their physician.

Laboratory customers who need to review the field correction action can do so by logging into their customer website at http://www.mylabonline.com/.

 

WEEK ENDING MAY 15


PRODUCT Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT-359L6 and MMT-359L9. (Differences in models is variation in length, 6 versus 9 MM.).
CODE All lots.
RECALLING FIRM/MANUFACTURER Medtronic MiniMed, Northridge , CA.
REASON Possibility of interrupted insulin flow.
VOLUME OF PRODUCT IN COMMERCE 1,676,546 units.
DISTRIBUTION Nationwide.

PRODUCT VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package.
CODE Lot #B28E.
RECALLING FIRM/MANUFACTURER bioMerieux Inc.
REASON Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.
VOLUME OF PRODUCT IN COMMERCE 1,990/20-card boxes.
DISTRIBUTION Nationwide and International.


PRODUCT Kreiger Tables, X-Ray tables for use with C-Arm X-Ray systems.
CODE Model Numbers: APS-1000, APS-1010, APS-1020T, APS-1020L, APS-1030, APS-1040, and APS-1050.
RECALLING FIRM/MANUFACTURER Krieger Medical, Inc., Woburn , MA.
REASON An incorrect identification label and the failure of certification testing program resulted in tables not complying with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE 351 units.
DISTRIBUTION Nationwide.

PRODUCT Concha IV Plus Heated Humidifier.
CODE All products manufactured with software 11738 -rev.03, Version V13.6, 252 A. This represents all units currently in the field.
RECALLING FIRM/MANUFACTURER Hudson Respiratory Care Inc, Temecula , CA.
REASON Software malfunction.
VOLUME OF PRODUCT IN COMMERCE 1049.
DISTRIBUTION Nationwide.

PRODUCT
a) AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450. 
b) AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451.
CODE
a) Lot/serial number 361100/001-005;
b) Lot/serial number 361101/001-005.
RECALLING FIRM/MANUFACTURER American Medical Systems, Minnetonka , MN.
REASON The product is mislabeled as to length.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION CA, TX, PR, Costa Rica and Taiwan .

PRODUCT
a) AMPLICOR HPV Master Mix Analyte Specific Reagent HPV MMX), Catalog number 03582841190.

b) AMPLICOR HPV Microwell Plate Analyte Specific Reagent MWP); catalog 03579229190. 
CODE
a) Lot E11927; exp. 10/04;
b) Lot E12989; exp. 7/04.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis , IN.
REASON Marketed without PMA or 510(k) approval.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION FL, and VA.

PRODUCT LIFEPAK 12 defibrillator/monitor.
CODE Part numbers VLP12, UVLP12, EVLP12, DVLP12, AVLP12, and any of these may have five to eight digits after the base number. Serial numbers can be obtained from the firm or FDA’s Seattle District Recall Coordinator.
RECALLING FIRM/MANUFACTURER Medtronic Physio Control Corp, Redmond , WA.
REASON Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator.
VOLUME OF PRODUCT IN COMMERCE 2,885 devices.
DISTRIBUTION Nationwide and Internationally.

PRODUCT SenoScan True View Digital Mammography System. 
CODE Serial Numbers: 9800-0103-001, 9800-0104-001, 0900-0104-002, 9800-0104-003, 9800-0203-001, 9800-0204-001, 9800-0204-002, 9800-0204-004, 9800-0204-005, 9800-0303-003, 9800-0402-003, 9800 0403-001, 9800-0502-001, 9800-0602-001R, 9800-0603-001, 9800-0603-002, 9800-0901-001R, 9800-0903-001, 9800-1001-001, 9800-1003-003, 9800-1003-004, 9800-1102-003, 9800-1102-007, 9800-1103-001, 9800-1103-002, 9800-1103-003, 9800-1103-004, 9800-1103-005, 9800-1103-006, 9800-1103-007, 9800-1103-008, 9800-1103-009, 9800-1103-011, 9800-1103-012, 9800-1202-003, 9800-1203-001, 9800-1203-002.
RECALLING FIRM/MANUFACTURER Fischer Imaging Corporation, Denver , CO.
REASON X-ray tube may overheat after high usage because of mis-wired thermal switch circuit.
VOLUME OF PRODUCT IN COMMERCE 37 units.
DISTRIBUTION Nationwide, Mexico , and France .

 

PRODUCT Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed).
CODE Model number DB513, Lot number M384030 exp. 7/08.
RECALLING FIRM/MANUFACTURER Surgical Specialties Corp, Reading , PA.
REASON Sterilization method incorrect.
VOLUME OF PRODUCT IN COMMERCE 2 boxes.
DISTRIBUTION Japan .

PRODUCT Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems. CODE All serial numbers.
RECALLING FIRM/MANUFACTURER Toshiba American Med Sys Inc, Tustin, CA.
REASON Software anomaly. The region of the body was scanned, was different than programmed.
VOLUME OF PRODUCT IN COMMERCE 50.
DISTRIBUTION Nationwide.

PRODUCT K-Assay Lp(a) Control. 
CODE Lot D407.
RECALLING FIRM/MANUFACTURER Kamiya Biomedical Company, Seattle , WA.
REASON Assay result not consistent with the assigned control value.
VOLUME OF PRODUCT IN COMMERCE 16.
DISTRIBUTION CA, PA, MN, GA, and MI.

 

WEEK ENDING MAY 22Skip Navigation

 

Medtronic Recalls Quick-Set® Plus Infusion Sets

 

Medtronic, Inc. today announced that its Diabetes division began notifying diabetic patients, healthcare professionals and distributors that it is conducting a nationwide recall of Quick-set ® Plus infusion sets because of problems that can interrupt insulin flow to diabetics who use them.

 

The company is asking patients to contact its 24-Hour Help Line at (800) MINIMED (1-800-646-4633) to exchange any unused Quick-set Plus infusion sets for replacement sets available currently from Medtronic. In the event that it is necessary to continue use of the Quick-set Plus while replacement sets are in transit, Medtronic is recommending that patients monitor their blood glucose levels frequently and be prepared to treat any elevated glucose levels that may occur with injections. Patients are also being instructed to contact their healthcare professional in the event of excessively high or low glucose levels or with any questions about their care. Information regarding the exchange of Quick-set Plus infusion sets is available at www.minimed.com/QSP.

 

This recall applies to all Paradigm Quick-Set Plus models (MMT-359S6, MMT-359S9, MMT-359L6 and MMT-359L9) and lot numbers.This action affects only the Quick-set Plus infusion set; no other Medtronic devices or infusion sets are involved in this recall.


PRODUCT Microwave Ovens (modified for visually-impaired users).
a) Brand name Magic Chef, Models DM81K, MC-1004;
b) Sharp, Models R-508AK, R-409AK;
c) Emerson brand "Talking" ovens (modified by Electronic Technical Services);
d) Goldstar, Models MA1012W and MA1112W;
e) General Electric, Models JES1036WF and JES638WF;
f ) E-Wave, Model EW6F6W.
CODE None supplied.
RECALLING FIRM/MANUFACTURER Electronic Technical Services, Ltd., Albuquerque, NM.
REASON The modified household microwave oven products failed to comply with the Federal Performance Standard for Microwave Ovens.
VOLUME OF PRODUCT IN COMMERCE 491 units.
DISTRIBUTION Nationwide.


PRODUCT Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/Ref: PRTB10A, Model No. M001PRTB10A.
CODE 916252, 917973.
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Natick, MA.
REASON Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.
VOLUME OF PRODUCT IN COMMERCE 72 units.
DISTRIBUTION Nationwide and Canada.

 

PRODUCT Minstrel Patient Lift; a non-AC-powered patient lift; Model Numbers HMB001-US and HMB002-US (with scale).

CODE All units with and without scales up to and including serial number MPLA0203A0464.
RECALLING FIRM/MANUFACTURER Arjo, Inc, Roselle, IL.
REASON The tension pin was not installed in spreader bar pivot bolt to prevent the pivot bolt from migrating out of the spreader bar, allowing the spreader bar to detach from the lift.
VOLUME OF PRODUCT IN COMMERCE 46 units.
DISTRIBUTION Nationwide.


PRODUCT
a) KCI TriaDyne Proventa Critical Care Therapy System, Model number 308900.
b) KCI Therapulse II Air Suspension Therapy Bed, Model Number 227080.

c) Burke Bariatric Bed, Model number 7064.
d) KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, Model number 201189.
CODE
a) The following serial numbers: TDBK00029, TDBK00294, TDBK00015, TDBK00291, TDBK00026, TDBK00027, TDBK00123, TDBK00124, TDBK00125, TDBK00127, TDBK00128, TDBK00130,
TDBK00132, TDBK00136;
b) Serial numbers: TPLK00053, TPLK00052, TPLK00011,TPLK00012, TPLK00013, TPLK00014, TPLK00015, TPLK00016, TPLK00124, TPLK00128, TPLK00132;
c) Serial numbers: B7A94031025, B7A94031024, B7A94031023, 000000093101003, 000000093101005, B7A94031010,
B7A94031011, B7A94031012, B7A94031013, B7A94031014, B7A94031015, B7A94031030, B7A94031031, B7A94031032, 0498107/335AGJ;
d) Serial numbers: IVAK00004, IVAK00023, IVAK00028, IVAK00034, IVAK00033, IVAK00032, IVAK00055, IVAK00060, IVAK00062, IVAK00063, IVAK00030, IVAK50000, IVAK00030, IVAK00035, IVAK00027, IVAK00054, IVAK00037, IVAK00041, IVAK00049, IVAK00044, IVAK00045, IVAK00046, IVAK00047,
IVAK00048, IVAK00038, IVAK00039, IVAK00042, IVAK00043, IVAK00051, 000038251, 000038253, 000038295, 000038299.
RECALLING FIRM/MANUFACTURER Kinetic Concepts, Inc., San Antonio, TX.
REASON Battery outgassing of powered hospital beds.
VOLUME OF PRODUCT IN COMMERCE 78 units.
DISTRIBUTION Nationwide.


PRODUCT
a) STAT-Check, Adult Manual Emergency Resuscitator with A.C.E./STAT-Check CO_ Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC 9000 Series.
b) STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO_ Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC-8000 Series.
c) A.C.E. STAT-Check CO_ Indicator, Single, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order# SC200.
d) STAT-Check Infant Disposable Manual Resuscitators, with 40 cmH_O Pressure Limiting System & Pressure Port Adapter, Single Patient Use Non-Sterile, Re-Order SC7000 Series, Non Latex. 
e) STAT-Check Infant Disposable Manual Resuscitators with Built-in Pressure Monitor, with 40 cmH_O Pressure Limiting System & Pressure Port Adapter, Single Patient Use, Non-Sterile, Re-Order SC7100 Series, Non Latex.
CODE
a) Model #SC9000B, Lot #4034-10, 4047-07, 4064-10; Model #SC9000C, Lot #3295-03; Model #SC9001B,

Lot #3290-03, 3309-22, 4047-05, 4064-11, 4071-13; Model #SC9001C, Lot #3290-04, 3309-24, 3349-05, 4034-04;
b) Model #SC8001B, Lot #3295-01, 4063-02, Model #SC8021C, Lot #4054-04, Model #SC8121B, Lot #4040-01, Model #8121C, Lot #4047-06;
c) Model #SC200, Lot #3254-03, 4020-01, 4040-09, 4043-05, 4056-05, 4063-07, 4064-20, 4078-03;
d) Model #SC7000B, Lot #4047-08;
e) Model #SC7101B, 4040-02, 4078-04, Model #SC7101C, Lot #3295-04.
RECALLING FIRM/MANUFACTURER Ventlab Corp, Mocksville, NC.
REASON In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
VOLUME OF PRODUCT IN COMMERCE 22,120 units.
DISTRIBUTION CA.


PRODUCT
a) Advantx 1 LC1, Model 46-279781P1, Angiographic X-ray System.
b) Advantx 1 LC1, Model 45258230, Angiographic X-ray System.
c) Advantx 1 LC2, Model 45562281, Angiographic X-ray System.
d) Advantx 1 LC2, Model 2105657, Angiographic X-ray System.
e) Advantx 1 SC, Model 36006617, Angiographic X-ray System.
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER General Electric Med Systems, Waukesha, WI.

REASON Unintended movements of both the C-arc and the image intensifier have occurred due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.
VOLUME OF PRODUCT IN COMMERCE 1,252 systems.
DISTRIBUTION Nationwide and Internationally.


PRODUCT
a) Baxter Renal Software Suite (Renal Link and PD Link).
b) Renalsoft software system.
CODE
a) Product codes 5M5590, 5M5591, 5M5592, 5M5593, 5M5594, 5M5595, 5M5596, 5M5603, 5M5604, R5C4532, R5C4534, 5M5597, 5M5541, 5M5541R, all software versions;
b) Product code RENLSFT, all software versions.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Renal Div., McGaw Park, IL.
REASON There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.
VOLUME OF PRODUCT IN COMMERCE 4,164 units.
DISTRIBUTION Nationwide.


PRODUCT Esprit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics.
CODE All codes.
RECALLING FIRM/MANUFACTURER Respironics California Inc., Carlsbad, CA.
REASON Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.
VOLUME OF PRODUCT IN COMMERCE 749 units.
DISTRIBUTION Nationwide, and Internationally.


PRODUCT UniCel Dxl 800 Access Immunoassay System, P/N 973100.
CODE All software versions prior to version 1.4.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Software coding error may cause a fatal error message.
VOLUME OF PRODUCT IN COMMERCE 73.
DISTRIBUTION Nationwide and Canada.


PRODUCT Coulter LH750 Hematology Analyzer. Part Number 6605632.
CODE Software versions 2A2 and 2B1.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON If a customer enters a dilution factor for Sample B prior to the results from Sample A being transferred to the workstation, the predilute multiplication factor will be applied erroneously to the Sample A's results once they are received at the workstation.
VOLUME OF PRODUCT IN COMMERCE 981.
DISTRIBUTION Nationwide and Canada.


PRODUCT Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40.
CODE Lot #/ Exp. date 3JR190 10/2006, 3KR128 11/2006, 3LR100 12/2006, 3MR002 12/2006, 3MR047 12/2006, 3MR048 12/2006, 3MR081 01/2007, 3MR082 01/2007, 4AR045 01/2007, 4AR050 01/2007, 4AR058 01/2007.
RECALLING FIRM/MANUFACTURER Allergan Medical Optics, Inc., Santa Ana, CA.
REASON The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. The blue wrapping within the tray may not be sterile and may pose a potential risk of infection to the patient if used in a sterile field.
VOLUME OF PRODUCT IN COMMERCE 19,087.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Biliary Stent Introducer Set. Reorder (catalog) number SIS-10.
CODE Lot number W1733880.
RECALLING FIRM/MANUFACTURER Wilson-Cook Medical Inc., Winston Salem, NC.
REASON The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter.
VOLUME OF PRODUCT IN COMMERCE 23 pieces.
DISTRIBUTION MO, NY, PA, Australia, Israel and England.


PRODUCT
a) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-9052A-ENG.
b) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-0613C-ENG.
c) Pinnacle3 Radiation Therapy Planning System, Part Number 9104-2011A Rev. A.
d) Pinnacle3 Radiation Therapy Planning System, Part Number 9104-0121C Rev. A.
e) Philips ADAC Pinnacle3 Radiation Therapy Planning Software Packaage (Kit), Model Number 9200-0613B-ENG.
f) Philips Pinnacle3 Radiation Therapy Planning Software CD, Part Number 9104-0121B, Rev. A.

CODE
a) Version 7.0e;
b) Version 6.6c;
c) Version 7.0e, Rev. A;
d) Version 6.6c, Rev. A;
e) Version 6.4a, Rev. A;
f) Version 6.4a, Rev. A;
RECALLING FIRM/MANUFACTURER ADAC Laboratories, Madison, WI.
REASON A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta Leksell headframe.
VOLUME OF PRODUCT IN COMMERCE 165 units.
DISTRIBUTION Nationwide, Australia, Canada, China, and Korea.


PRODUCT Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Model AED 10, part numbers 970300 (defibrillator) and 970302 (defibrillator with soft shell carrying case).
CODE Serial numbers 4613, 4888/4891, 4897, 6369/6386, 6396/6704, 6706, 6709/6743, 6745/6803, 6806, 6807, 6809, 6811, 6813/6832, 6836/6838, 6853/6855, 6912, 6914, 6917, 6921, 6922, 6924/6926.
RECALLING FIRM/MANUFACTURER MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL.
REASON A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator.
VOLUME OF PRODUCT IN COMMERCE 460 units.
DISTRIBUTION Nationwide, and Internationally.


PRODUCT VITEK GPS-107 Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package.
CODE Lot #P108X.
RECALLING FIRM/MANUFACTURER BioMerieux, Inc., Hazelwood, MO.
REASON Some of the cards were stamped with an incorrect card code causing system to read and report the cards incorrectly.
VOLUME OF PRODUCT IN COMMERCE 1,760/20-card boxes.
DISTRIBUTION Nationwide, China, and Switzerland.


PRODUCT Opthalmic Laser, product number 8065-5000-1.
CODE None.
RECALLING FIRM/MANUFACTURER Alcon Research, Ltd., Fort Worth, TX.
REASON Product may generate laser light flashback.
VOLUME OF PRODUCT IN COMMERCE 62.
DISTRIBUTION Nationwide and Internationally.


PRODUCT Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081.
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER Medtronic Gastroenterology/Urology, Shoreview, MN.
REASON Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.
VOLUME OF PRODUCT IN COMMERCE 42 units.
DISTRIBUTION Nationwide.


PRODUCT
a) ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM.
b) ACMI REF E-3F Electrohydraulic Lithotripsy Probe, 3 FR x 120CM.
c) ACMI REF E-5F Electrohydraulic Lithotripsy Probe, 5 FR x 60CM.
d) ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM.
CODE
a) Lot Numbers: 1122753E to 1283804C;
b) Lot Numbers: 1122743E to 1269284B;
c) Lot Numbers: 1122733E to 1262504A;
d) Lot Numbers: 115823D to 1283724C.
RECALLING FIRM/MANUFACTURER ACMI Corp., Southborough, MA.
REASON Product sterility may be compromised due to the lack of package seal integrity.
VOLUME OF PRODUCT IN COMMERCE 3,056 boxes.
DISTRIBUTION Nationwide, and Internationally.

 

PRODUCT Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).
CODE Lot M207140.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Product was found to produce higher recoveries by about 7-12% compared to other lots.
VOLUME OF PRODUCT IN COMMERCE 9,126.
DISTRIBUTION Nationwide and Canada.


PRODUCT
a) Tachos DR - Implantable Cardioverter Defibrillator. Model Number 335 572.
b) Tachos DR - Atrial Tx, Model Number 122 499.
c) Tachos Atx, Model Number 334 342.
d) Deikos A+, Model Number 3340341.
CODE
a) Serial numbers: 78011709 - 78011712, 78011714 -78011719, 78011725 - 78011729, 78011759 - 78011763,
78011769 - 78011778, 78011780 - 78011791, 78011793 - 78011829, 78011831, 78011833 - 78011864, 78011866 -
78011928, 78011930 - 78011937, 78011939 - 78011949, 78011951 - 78011981, 78011983 - 78011985, 78011987 -
78011988, 78019000 -78019014, 78019016 - 78019025, 78019027, 78019029 - 78019035, 78019037 - 78019051,
78019053 - 78019066, 78019068 - 78019081, 78019083, 78019084, 78019086 - 78019091, 78019096 - 78019099,
78019101 - 78019105, 78019107 - 780190122, 78019126 - 780190129, 78019131 - 78019140;
b) Serial numbers: 78012522, 78012524, 78012525, 78012548, 78012675, 78012677, 78012681, 78012683, 78012707,
78012709 - 78012712, 78012714, 78012715, 78012718, 78012719, 78012763, 78012767, 78012768, 78012771,
78012791, 78012792, 78012794, 78012804, 78012809, 78012815 - 78012820, 78012968, 78012987 - 78012989,
78013072 - 78013076, 78013092 - 78013094, 78013099, 78013100, 78013165 - 78013185, 78013194, 78013198,
78013200 - 78013204, 78013206, 78013207, 78013210, 78013217 - 78013220, 78013222, 78013224 - 78013227,
78013230 - 78013256, 78013258 - 78013262, 78013278, 78013282, 78013284, 78013285, 78013292, 78013297,
78013299, 78013315, 78013317, 78013321;
c) Serial numbers: 78050083 - 78050088, 78050091 - 78050095, 78050097, 78050098, 78050100, 78050103 -
78050105, 78050107, 78050109, 78050110, 78050113, 78050117 - 78050122, 78050124 - 78050128, 78050133 -
78050139, 78050142 - 78050144, 78050162 - 78050169;

d) Serial numbers: 78062958, 78062960, 78062961, 78062962, 78062997, 78063002.
RECALLING FIRM/MANUFACTURER Biotronik, Inc., Lake Oswego, OR.
REASON Potential for device to not deliver full amount of energy.
VOLUME OF PRODUCT IN COMMERCE 547.
DISTRIBUTION Nationwide.


PRODUCT
a) Stylus Angled Knife - 52-2835 Clear Corneal Knife, double bevel, parallel sides, angled, full handle, 2.85
b) Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, Pilot Tip
Knife, bevel up, angled, full handled, 5.2mm.

c) Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm 52-2761, Slit Knife,
bevel up, angled, full handled, 2.75mm 52-2861, Slit Knife, bevel up, angled, full handled, 2.85mm 52-2961,
Slit Knife, bevel up, angled, full handled, 3.0mm 52-3261, Slit Knife, bevel up, angled, full handled, 3.2mm
52-3561, Slit Knife, bevel up, angled, full handled, 3.5mm 52-2662, Slit Knife, bevel up, angled, blade and
tip, 3.2mm 52-3262, Slit Knife, bevel up, angled, blade and tip, 3.2mm. Recall Z-0947-04;
d) Stylus Brand Angled Knife - 52-2931, Slit Knife, double bevel, angled, full handle, 3.0mm 52-3231, Slit Knife,
double bevel, angled, full handle, 3.2mm.

e) Stylus Brand Angled Knife - 54-1010, Sharptome Crescent Knife, bevel up, angled, full handled. 54-1031,
Sharptome Crescent Knife, double bevel, angled, full handled.
f) Stylus Brand Angled Knives - 52-2912, Slit Knife, parallel sides, bevel up, angled, full handle, 3.0mm 52-
3212, Slit Knife, parallel sides, bevel up, angled, full handle, 3.2mm.
CODE
a) Model No. Lot # Exp. date 52-2835 M454660 2/2009 52-2835 M317210 7/2008;
b) Model No. Lot # Exp. date 56-5361 M262510 5/2008 56-5361 M309090 6/2008 56-5361 M309150 11/2008 56-5361 M439510 1/2009 56-5161 M317030 6/2008;
c) Model No. Lot # Exp.date 52-2661 M309600 5/2008 52-2662 M309610 8/2008 52-2661 M309620 8/2008 52-2661 M309630 8/2008 52-2661 M264510 3/2008 52-2761 M436360 12/2008 52-2761 M309720 9/2008 52-2761 M309730 9/2008 52-2761 M365020 10/2008 52-2761 M365030 11/2008 52-2861 M309770 5/2008 52-2861 M309780 7/2008 52-2861 M430490 12/2008 52-2861 M437160 1/2009 52-2861 M439540 1/2009 52-2861 M309790 8/2008 52-2861 M309810 9/2008 52-2961 M376790 8/2008 52-2961 M309860 6/2008 52-2961 M309870 7/2008 52-2961 M416990 10/2008 52-3261 M440600 2/2009 52-3261 M262580 3/2008 52-3261 M309940 7/2008 52-3261 M309960
8/2008 52-3261 M309970 8/2008 52-3561 M311070 4/2008 52-2662 M445610 2/2009 52-3262 M280120 3/2008;
d) Model No. Lot # exp. date 52-2931 M310120 7/2008 52-2231 M310180 8/2008 52-3231 M310190 6/2008;
e) Model No. Lot # Exp. Date 54-1010 M316220 9/2008 54-1010 M316160 7/2008 54-1010 M316180 7/2008 54-1031 M365220 10/2008;
f) Model No. Lot # Exp. date 52-2912 M314590 5/2008 52-3212 M359090 7/2008.
RECALLING FIRM/MANUFACTURER Surgical Specialties Puerto Rico, Inc., Rincon, PR.
REASON Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
VOLUME OF PRODUCT IN COMMERCE 77,340 units.
DISTRIBUTION Nationwide and Internationally.


PRODUCT BioPince Full Core Biopsy Instrument packed in a Tyvek/plastic blister pack which is labeled as previously stated and also in a cardboard shelf carton.
CODE
Part Number/Lot Number: 360-1080-01, 24821; 360-1080-01, 30531; 360-1080-01, 30811; 360-1080-01, 30923; 360-1080-02, 24821; 360-1080-01, 31251; 360-1080-01, 32211; 360-1080-01, 32842; 360-1080-01, 32851-1;
360-1080-01, 32851-2; 360-1080-01, 33451; 360-1080-01, 33452; 360-1080-01, 33832; 360-1080-01, 34031; 360-1080-01, 34331; 360-1080-01, 34512; 360-1080-01, 34721; 360-1580-01, 30633; 360-1580-01, 31042; 360-1580-01, 32032; 360-1580-01, 32341; 360-1580-01, 32852; 360-1580-01, 33433; 360-1580-01, 33434; 360-1580-01, 34232; 360-1580-01, 34931; 360-1580-01, 32852-2; 360-2080-01, 30751; 360-2080-01, 30811; 360-2080-01, 31531; 360-2080-01, 33331; 360-2080-01, 33332; 360-2080-01, 34221; 360-2080-01, 34322; 360-2080-01, 34734; 360-2080-01, 34941; 363-1080-01, 32431; 364-1080-01, 34549; 364-1580-01, 34432; 370-1080-01, 33932; 370-1080-01, 35032; 370-1580-01, 34447; 370-1580-01, 35021.
RECALLING FIRM/MANUFACTURER Medical Device Technologies, Inc., Gainesville, FL.
REASON The outer plastic blister packaging material may be cracked thereby compromising the device's sterility barrier.
VOLUME OF PRODUCT IN COMMERCE 10,303.
DISTRIBUTION Nationwide and Internationally.


PRODUCT AcuSnare" Polypectomy Device. The SASM device prefix denotes Soft AcuSnare Mini, Reorder (Catalog) number: SASM -1. The ASM device prefix denotes Acu Snare Mini, Reorder (Catalog) number: ASM-1. Due to the nitinol core wire, the difference between these two products is stiffness of the snare head wire. CODE
SASM-1 Lot # W1834310;
ASM-1 Lot # W1834120.
RECALLING FIRM/MANUFACTURER Wilson-Cook Medical, Inc., Winston Salem, NC.
REASON The snares inside the box labeled SASM-1 may actually be ASM-1 devices. The individual pouches may be correctly labeled ASM.
VOLUME OF PRODUCT IN COMMERCE 5 boxes/10 pouches per box.
DISTRIBUTION MA, NY, and OK.


PRODUCT
a) 955-3 BacFix Coldwelder.
b) 955-4 BacFix Coldwelder II with angled tip.

c) 955-5 BacFix Coldwelder II with straight tip.
CODE All codes.
RECALLING FIRM/MANUFACTURER Spinal Concepts, Inc, Austin, TX.
REASON The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.
VOLUME OF PRODUCT IN COMMERCE 285 units.
DISTRIBUTION Nationwide, and Germany, Japan, and Italy.


PRODUCT
a) Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number
18-83070.
b) The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths.
c) The product is a device used in adenoid surgery and is labeled as Lusk Disposable Adenoid Curettes.
CODE
a) Lot 26371200;
b) Lots 31396400 and 30722300;
c) Lot 30685400.
RECALLING FIRM/MANUFACTURER Medtronic Xomed, Inc., Jacksonville, FL.
REASON
a) The curve in the shaft of the bur was only 15 degrees not the labeled 40 degrees;
b) The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label;
c) The box label indicated that the product is size 2 whereas a size 4 was packed inside.
VOLUME OF PRODUCT IN COMMERCE 33 boxes.
DISTRIBUTION Nationwide.

 

WEEK ENDING MAY 29Skip Navigation

 

Arjo, Inc. Announces a Nationwide, Voluntarily Recall of the MINSTREL Patient Lifts


Arjo, Inc. today announced that it is voluntarily conducting, a recall for two models, HMB001-US (with out scale) and HMB002-US (with scale) of its MINSTREL Patient Lifts because of mechanical problems that could result in serious patient injury.

 

This recall involves 116 MINSTREL Patient Lifts that could possibly result in hanger bar detachment due to pin migration or pin breakage in the hanger bar assembly. No other Arjo, Inc. devices are involved in this action.

 

All affected customers were formally notified via certified mail of the MINSTREL Field Correction/Recall on April 30, 2004 . Affected customers have already been advised to exercise the option of inspecting their MINSTREL Patient Lift and completing an Inspection Form or removing their MINSTREL Patient Lift from use pending repair from an authorized Arjo Service Technician. Affected customers have also been advised to complete a Customer Response Form and return it to Arjo, Inc. Quality Assurance Department.

 

Appropriate corrective action was taken to eliminate the MINSTREL problem and 100 units have already been repaired. The remaining 16 MINSTREL Lifts will be repaired by May 28, 2004.

 

Arjo, as a global leader in patient lifts, is committed to ongoing product surveillance to assure product safety and reliability.

 

Any inquiries regarding this action should be directed to the Quality Assurance Department, 1.800.323.1245, ext. 6140 or 6103

 

 


PRODUCT 100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Sterile with non-stick pad. 100% Latex Free Bandage & Wrapper. 48 boxes of 100 bandages per case. Device Listing # E177598.510 (k) Exempt.

CODE Lot Number 15860.
RECALLING FIRM/MANUFACTURER Dynarex Corp., Orangeburg, NY.
REASON Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex.
VOLUME OF PRODUCT IN COMMERCE 50 cases.
DISTRIBUTION Nationwide, and Puerto Rico.


PRODUCT
a) Auto Suture TA 30 Reloadable Staplers, Single Patient Use Ref TA30V3S, V3 (2.5mm) DST Series.
b) Auto SutureTA 30 Reloadable Stapler, Single Patient Use, 3.5mm DST Series Ref: TA3035S.
c) Auto SutureTA 30 Reloadable Stapler, Single Patient Use, 4.8mm DST Series Ref: TA30348S.
d) Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA4535S.
e) Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA4548S.  
f) Auto SutureTA 60 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA6035S.
g) Auto SutureTA 60 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA6048S.
h) Auto SutureTA 90 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA9035S.
i) Auto SutureTA 90 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA9048S.
CODE
a) LOT# P2J507 P2J972 P2K1034 P2K616 P2L334 P2L335 P2L607 P2M694 P2M695 P3A83 P3B307 P3D245 P3D564 P3E236 P3E309 P3F683 P3G300 P3G855 P3H21 P3J263 P3J408 P3J42 P3K13 P3L1011 P3L1012 P3L1133 P3L1134 P3L13 P3L237 P3L447 P3L628 P3L728 P3M558 P3M668 P4A636 P4B176 U2H11 U2H17 U2J01 U2J02;
b) LOT# P2J505 P2J971 P2K1031 P2K813 P2L332 P2L603 P2L604 P2M227 P2M228 P2M235 P2M82 P3A1151 P3A323 P3A443 P3A908 P3B336 P3B607 P3C710 P3C802 P3D563 P3D944 P3E233 P3E294 P3G08 P3G09 P3G417 P3G621 P3G769 P3H288 P3H638 P3J41 P3J456 P3K05 P3K06 P3K07 P3K08 P3L1007 P3L1008 P3L11
P3L1129 P3L1130 P3L12 P3L243 P3L42 P3L425 P3L440 P3L441 P3M368 P3M369 P4A634 P4A881 U2H02 U2H08;
c) LOT# P2J506 P2J508 P2K1032 P2K186 P2K614 P2L333 P2M236 P2M549 P2M550 P2M703 P3A1149 P3A1150 P3A453 P3B340 P3C803 P3D86 P3E234 P3E296 P3G10 P3H287 P3H639 P3J245 P3J458 P3K10 P3K11 P3L1009 P3L1010 P3L1131 P3L1132 P3L233 P3L234 P3L43 P3L443 P3L445 P3L446 P3L727 P3L87 P3M366 P3M367 P3M550 P4B161 U2H01 U2H09;
d) LOT# P2J450 P2J795 P2J796 P2J797 P2J798 P2L657 P2M193 P2M241 P2M542 P2M98 P3A412 P3A91 P3A92 P3A93 P3B345 P3B608 P3B609 P3B610 P3C238 P3D246 P3D568 P3D947 P3E237 P3E300 P3E523 P3F113 P3F684 P3G960 P3J237 P3J43 P3J44 P3J459 P3J711 P3K15 P3L1135 P3L1136 P3L1152 P3L235 P3L236 P3L448 P3L449 P3L629 P3L997 P3L998 P3M672 P3M673 P4A554 P4A637 P4A883 P4B585 U2E11 U2F13 U2F17 U2G02
U2G03 U2G11 U2G13;
e) LOT# P2H776 P2J263 P2J607 P2J792 P2J793 P2L647 P2L648 P2M243 P2M244 P2M552 P3A118 P3A413 P3A909 P3B341 P3B342 P3B343 P3B344 P3B611 P3B848 P3C239 P3C241 P3C437 P3C439 P3C588 P3E18 P3E238 P3E301 P3E524 P3E525 P3E647 P3F115 P3F225 P3F352 P3F446 P3H252 P3H280 P3H404 P3H431 P3H432 P3H640 P3H641 P3J45 P3J46 P3J47 P3J712 P3J713 P3K20 P3L1004 P3L1005 P3L1006 P3L1138 P3L1139 P3L238 P3L239
P3L450 P3L630 P3L631 LOT# P3L729 P3M464 P4A126 P4A128 P4A336 P4A337 P4A338 P4A544 P4A549 P4A884 P4A885 P4B242 P4B587 P4B710 U2E10 U2E12 U2F02 U2F16 U2F20 U2G04 U2G06 U2G09;
f) LOT# P2G906 P2G907 P2G908 P2J239 P2J239A P2J451 P2J559 P2K1053 P2K1054 P2K1055 P2K334 P2K617 P2L129 P2L130 P2L131 P2L651 P2L652 P2L653 P2L654 P2M194 P2M195 P3A119 P3A120 P3A121 P3A415 P3A416 P3A417 P3A646 P3A910 P3B33 P3B34 P3C627 P3C738 P3D249 P3D251 P3D252 P3D571 P3D572 P3D582 P3D583 P3F464 P3F465 P3F466 P3F467 P3F685 P3G195 P3G196 P3G197 P3G766 P3G871 P3H248 P3H250 P3J460 P3J48
P3J49 P3J50 P3J719 P3K22 P3K23 P3K24 P3K25 P3K358 P3K359 P3L1000 P3L1001 P3L1002 P3L1003 P3L1144 P3L1145 P3L1146 P3L1148 P3L225 P3L226 P3L227 P3L228 P3L452 P3L453 P3L454 P3L455 P3L456 P3L633 P3L634 P3L635 P3L636 P3L637 P3L999 P3M551 P4A130 P4A133 P4A135 P4A560 P4A641 P4A888 P4B243 P4B267 U2F03 U2F07 U2F12 U2F27;
g) LOT # P2H15 P2J240 P2J240A P2J265 P2J784 P2J786 P2K827 P2L124 P2L655 P2L656 P2M96 P3A418 P3A648 P3A940 P3A98 P3C01 P3C423 P3C626 P3D21 P3D280 P3D584 P3D951 P3F468 P3G914 P3H249 P3H444R P3H566 P3J238 P3J462 P3J463 P3L1149 P3L1150 P3L229 P3L230 P3L240 P3L241 P3L458 P3L459 P3L460 P3L638 P3L730 P3L994 P3L995 P3L996 P4A138 P4A889 P4B270 P4B591 P4B714 P4B716 U2E13R U2F08 U2F28 U2F30;
h) LOT# P2H679 P2J642 P2K1113 P2K534 P2K66 P2L609 P2L610 P2L611 P2L649 P2M692 P3A650 P3C425 P3C800 P3E304 P3F686 P3G15 P3G414 P3J249 P3J250 P3J256 P3L1013 P3L1141 P3L242 P3L44 P3L462 P3L639 P4A547 P4A642 P4A890 P4B727 U2G21;
i) LOT# P2H677 P2H678 P2J787 P2J788 P2L645 P2L646 P2L650 P2M226 P2M693 P3A652 P3B308 P3B613 P3C426 P3C432 P3C819 P3D953 P3E649 P3F116 P3F841 P3G16 P3G17 P3H281 P3H282 P3H447 P3H448 P3K27 P3K362 P3L1014 P3L1015 P3L1142 P3L231 P3L232 P3L45 P3L464 P3L465 P3L466 P3L731 P4A546 P4A643 P4A891 U2G15;
RECALLING FIRM/MANUFACTURER United States Surgical, North Haven, CT.
REASON Stapler may clamp without the staples being fired into the tissue.
VOLUME OF PRODUCT IN COMMERCE 195,690 units.
DISTRIBUTION Nationwide.


PRODUCT
a) Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventilator, on a Aestiva/5 Anesthesia Machine.
b) Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventilator, on a Aestiva/5
Anesthesia Machine.
c) Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7900 Ventilator, on a Aestiva/5
Anesthesia Machine, in a Magnetic Reasonance Suite.
CODE
a) Serial numbers AMRG02807, AMRG02889 thru AMRG02899, AMRG02930, AMRG02937 thru AMRG02942, AMRG02955, AMRG02958, AMRG02967, AMRG02968, AMRG02969, AMRG02979 thru AMRG03005, AMRG03012 thru AMRG03014, AMRG03017, AMRG03018, AMRG03030, AMRG03057 thru AMRG03062,
AMRG03072, AMRG03077, AMRG03080, AMRG03081, AMRG03084, thru AMRG03088, AMRG03115, AMRG03155, AMRG03156, AMRG03174, AMRG03180 thru AMRG03185, AMRG03198, AMRG03199, AMRG03201, AMRG03208, AMRG03209, AMRG03212 thru AMRG03215, AMRG03222 thru AMRG03224, AMRG03261 thru AMRG03270, AMRG03298 thru AMRG03306, AMRG03331 thru AMRG03347, AMRG03351 thru AMRG03353, AMRH00124, thru AMRH00140, AMRH00143, AMRH00151, AMRH00152, AMRH00163,
AMRH00169, AMRH00169, AMRH00170, AMRH00174 thru AMRH00181, AMRH00184, AMRH00185, AMRH00190 thru AMRH00202, AMRH00232 thru AMRH00237, AMRH00243, AMRH00244, AMRH00246, AMRH00247, AMRH00259, thru AMRH00276, AMRH00290 thru AMRH00307, AMRH00309, thru
AMRH00311, AMRH00328, AMRH00329, AMRH00363 thru AMRH00368, AMRH00376, AMRH00382, thru AMRH00387, AMRH00396 thru AMRH00399, AMRH00399, AMRH00429, AMRH00430, AMRH00433, thru AMRH00439, AMRH00445 thru AMRH00464, AMRH00468, AMRH00469, AMRH00472 thru AMRH00474, AMRH00497 thru AMRH00502, AMRH00511 thru AMRH00513, AMRH00538 AMRH00543, AMRH00561 thru AMRH00571 thru AMRH00587, AMRH00589 thru AMRH00591, AMRH00594, AMRH00597 thru AMRH00603, AMRH00605 thru AMRH00626, AMRH00628 thru AMRH00636, AMRH00651, AMRH00652, AMRH00655 thru AMRH00657, AMRH00659 thruAMRH00661, AMRH00663 thru AMRH00669, AMRH00671, AMRH00672,
AMRH00674 thru AMRH00676, AMRH00682, AMRH00684, and AMRH00704 thru AMRH00717;
b) Serial numbers AMVG01045, AMVG01047, AMVG01052, AMVG01062, AMVG01072 thru AMVG01083, AMVH00100 thru AMVH00109, AMVH00116, AMVH00125, AMVH00126, AMVH00129, AMVH00132, AMVH00133, AMVH00139, AMVH00141 thru AMVH00148, AMVH00151 thru AMVH00154, AMVH00159,
AMVH00160, AMVH00164, AMVH00166, AMVH00159, AMVH00160, AMVH00164, AMVH00166, AMVH00171 thru AMVH00186, AMVH00195 thru AMVH00198, AMVH00211, and AMVH00228 thru AMVH00230;
c) Serial numbers AMTG00208, AMTG00212, AMTG00213, AMTG00216, AMTG00219, AMTG00220, AMTG00222, AMTH00113, AMTH00121, and AMTH00124.
RECALLING FIRM/MANUFACTURER Datex-Ohmeda, Inc., Madison, WI.
REASON Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.
VOLUME OF PRODUCT IN COMMERCE 466 units.
DISTRIBUTION Nationwide and Internationally.


PRODUCT DC Power Adapter for use with the LIFEPAK 12 defibrillator/monitor. Part numbers: VLP12-09-000031 through VLP12-09-000047.

CODE Serial numbers: 1563 through 5232 (non-contiguous).
RECALLING FIRM/MANUFACTURER Medtronic Physio Control Corp., Redmond, WA.
REASON The DC Power Adapter may fail to charge LIFEPAK NiCd 2.4 AH batteries used with the LIFEPAK 12 defibrillator/monitor.
VOLUME OF PRODUCT IN COMMERCE 1,689.
DISTRIBUTION Nationwide.


PRODUCT Immulite 1000 CEA. Catalog No. LKCE1.  
CODE Lots 5 157 and 5 157L.
RECALLING FIRM/MANUFACTURER Diagnostic Products Corp., Los Angeles, CA.
REASON Instability. Controls tend to run high of their target range.
VOLUME OF PRODUCT IN COMMERCE 884.
DISTRIBUTION Nationwide and worldwide.


PRODUCT MicroSTAAR Injector, MSI-PF Packed ten per box.
CODE Lot 1186591 Expires 12/31/06, Lot 1186692 Expires 12/31/06.
RECALLING FIRM/MANUFACTURER Staar Surgical Co., Inc., Monrovia, CA.
REASON Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.
VOLUME OF PRODUCT IN COMMERCE 124 boxes, 10 per box.
DISTRIBUTION Nationwide.