2006 Product Recalls
1,389 recalls issued in 2006.
Showing 1–20 of 1,389 recalls
Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75
A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent.
Notification was sent to ev3 Territory Managers to have them contact their customer, have them remove affected product from their shelves and place them aside. TheTerritory Manager is responsible for retreiving affected product and returning it to ev3.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225.
Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). The % CO values displayed will be lower than the actual CO2 value.
On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)
Display in fused mode- viewer allows 2 studies ( PET/CT) registered in the same spatial domain to be viewed simultaneously. These 2 images should be visually aligned to a precision of less than 1/2 PET Voxel. A problem associated with this version of software may introduce a shift of up to 1.5 PET Voxels, which can be as much as 8 mm with certain zoom factors.
An Urgent Safety Notice letter, dated October 8, 2004,(5121309-147, rev.E) was distributed to affected customers and a validated software patch that corrected the problem was installed on affected systems via Field Modification Instruction (FMI) 80114.
Scanlan Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree angled micro fine blades, 6-1/4'', 16 cm. Catalog Number 7007-449.
Some scissors purchased before May 1, 2005 may not perform properly. They may have a crack in the blade that could break.
Urgent Medical Device Recall letters were sent 07/27/05 to distributors asking them to retrieve affected product from their customers and return it to Scanlan International, Inc., St. Paul, MN. Distributors are asked to complete and return a Return Fax Form by August 4, 2005 to acknowledge receipt of letter.
Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.
Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot V009546 may contain a 3777 standard-spaced lead. The result of this error is an overall increase or decrease of 14 mm in the electrode coverage.
Medtronic representatives retrieved non-implanted devices. An Urgent Medical Device Recall letter was sent to physicians to describe the issue and patient management information.
Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Final software load did not occur prior to shipment of select programmers.
Sales Representatives were asked to retrieve/return identified monitors.
CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricualar tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with suden cardiac death (SCD). Cardiac resynchron
Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted.
Affected physicians were sent an Urgent Medical Device Safety Information & Corrective Action letter, dated 05/11/06. A press release was issued March 13, 2006 The letter describes the issue and emphasizes the importance of checking battery voltage prior to implant as stated in device labeling. For implanted devices, continue normal follow-up.
Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtronic Paceart System is a personal computer based pacemaker-testing system, a 12-lead electrocardiograph, and a transtelephonic receiving station. It provides data that can be used to analyze implanted pacemaker performance based on electrocardiographic measurements, either taken directly from the patient or programmer. The system can measure, store, and display any of the 12 s
The Paceart System could inappropriately insert data from a patient's Medtronic CareLink transmission into another patient's Paceart record. An issue associated with the automated batch transfer of implanted cardiac device data from the Medtronic CareLink network to the Paceart System exists.
Affected user and potential users of the Gateway product were notified via phone and/ or a customer notification. The notification offers interim options until a software update is available. Customers are asked to respond back to Metronic with an enclosed Acknowledgement form.
CONTAK RENEWAL 3 CRT-D (model no. H170, H173, H175) and CONTAK RENEWAL 3 HE CRT-D(model no. H177 and H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 5511-5798 USA. CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is unaffected.
Firm issued a Dr. Doctor letter dated 06/23/05. Letter informs physicians of the issue, clinical implications and recommendations. UPDATE: An Advisory Update, dated 08/01/05 is being issued to physicians to inform them of a new programmer software application upgrade and the programmer screen alerts. Additionally regulatory approval was given for a new switch component that will be incorporated into all Guidant CRT-D products.
Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4672-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand cover, Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, Vein Pick, Point-Lok Sharps Safety Device, Product
Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are supplied on the outside of PORT-A-CATH and P.A.S. PORT sterile trays, may have an insufficient seal and product sterility could be compromised.
An Urgent Product Safety & Recall Notification, dated 09/27/06, was sent to customers via facsimile and phone calls were made. The letter describes the issue and customers are given 3 options to include: use only the sterile tray and discard the wand cover, remove and discard Locator-Wand Cover pouches and request replacement Locator-Wand Covers, or return the entire device for a credit or replacement.
Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311. Nonpyrogenic.
Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid could compromise the device delivery.
Affected customers were mailed an Urgent Medical Device Recall or Correction - Immediate Action Required letter, dated 05/22/2006. The letter describes the issue, states to immediately discontinue use of and segregate recalled product, provides instructions to ship product back to Boston Scientific and asks for the Reply Verification Tracking Form to be faxed to Boston Scientific in acknowledgement.
BELT SEPARATION
A BELT SEPARATION COULD RESULT IN A VEHICLE CRASH.
DEL-NAT WILL NOTIFY OWNERS AND REPLACE THE DEFECTIVE TIRES FREE OF CHARGE. THE RECALL BEGAN ON OCTOBER 25, 2006. OWNERS MAY CONTACT DEL-NAT AT 901-775-8127.
FMVSS 403/WHEELCHAIR LIFT
THE WHEELCHAIR OCCUPANT WILL FEEL HIS/HER WHEELCHAIR MOVING UPWARD CAUSING OCCUPANT TO BEGIN TO TILT BACKWARD.
RICON WILL NOTIFY OWNERS AND REPAIR THE LIFTS FREE OF CHARGE. THE RECALL BEGAN ON JANUARY 26, 2007. OWNERS CAN CONTACT RICON TOLL-FREE AT 1-800-322-2884.
SHIFTER INDICATOR INTERFERENCE
THIS CONDITION WILL ALLOW THE VEHICLE TO MOVE IN AN UNINTENDED IDRECTION, POSSIBLY RESULTING IN A CRASH.
THE VEHICLE MANUFACTURERS WILL NOTIFY OWNERS AND PROVIDE A REMEDY FREE OF CHARGE. OWNERS MAY CONTACT THE MANUFACTURERS OF THEIR BUSES OR CONTACT ZF GROUP NORTH AMERICAN OPERATIONS AT 1-734-416-6200 FOR MORE INFORMATION.
TRAILER LIGHT MODULES
THE MODULE MAY OVERHEAT AND IGNITE.
UTILIMASTER WILL REMOVE THE TRAILER LIGHT MODULE AND WIRE THE TAIL LIGHT HARNESS FROM THE BODY DIRECTLY TO THE TRAILER PLUG. THE RECALL BEGAN ON DECEMBER 18, 2006. OWNERS MAY CONTACT UTILIMASTER AT 1-800-582-3454.
STOP ARM MAY NOT DEPLOY
A NON-DEPLOYING STOP ARM MAY ENCOURAGE MOTORISTS TO PASS THE SCHOOL BUS DURING PICK-UP OR DISCHARGE OF CHILDREN, POSSIBLY RESULTING IN SERIOUS INJURY.
THOMAS BUILT WILL NOTIFY OWNERS AND REPAIR THE BUSES FREE OF CHARGE. THE RECALL WILL BEGIN ON MARCH 29, 2007. OWNERS MAY CALL THOMAS BUILT AT 336-889-4871 OR OWNERS MAY CONTACT FREIGHTLINER AT 800-547-0712.
ACCELERATOR PEDAL
OVER TIME, THE PEDAL MAY NOT MAINTAIN A CONSISTENT PEDAL POSITION, WHICH COULD MAKE IT MORE DIFFICULT TO OPERATE THE ACCELERATOR.
DEALERS WILL INSPECT AND, IF NECESSARY, INSTALL THE MOUNTING NUTS OF THE ACCELERATOR PEDAL. THE RECALL BEGAN ON JANUARY 16, 2007. OWNERS MAY CONTACT MERCEDES-BENZ AT 1-800-367-6372.
HEATING, VENTILATION & AIR CONDITIONING MODULE
THIS CAN DECREASE THE DRIVER'S VISIBILITY UNDER CERTAIN DRIVING CONDITIONS AND RESULT IN A CRASH WITHOUT WARNING.
DEALERS WILL REPROGRAM THE HVAC MODULE. THE RECALL BEGAN ON JANUARY 2, 2007. OWNERS MAY CONTACT DAIMLERCHRYSLER AT 1-800-853-1403.
ABS CONTROL MODULE
THIS COULD RESULT IN A LOSS OF VEHICLE CONTROL AND CAUSE A CRASH WITHOUT WARNING.
DEALERS WILL REPROGRAM THE ABS ELECTRONIC CONTROL UNIT. THE RECALL BEGAN ON FEBRUARY 19, 2007. OWNERS MAY CONTACT DAIMLERCHRYSLER AT 1-800-853-1403.
BRAKE AIR DRYER/GRAHAM WHITE
THE BUS MAY NOT PERFORM AS EXPECTED WHEN STOPPING, INCREASING THE RISK OF A CRASH.
DAIMLERCHRYSLER IS WORKING WITH GRAHAM WHITE TO DEVELOP A REMEDY. OWNERS ARE BEING ASKED TO INSPECT THE WET BRAKE AIR TANK FOR MOISTURE BY USING A MANUAL DRAIN. ONLY TWO CUSTOMERS ARE INVOLVED AND HAVE BEEN CONTACTED.