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September 2010 vol. 19:13

FDA Recalls and/or Manufacturer Product Advisories and Field Corrections

Product distribution is nationwide unless otherwise specified. Contact the Home Office in Dallas for additional information. We cannot always include the serial and lot numbers affected by each recall, as both are often extensive. We also include recalls designated as COMPLETE. The “COMPLETE” designation does not guarantee that all users have been contacted – but signifies that FDA had determined that the manufacturer or supplier has completed due diligence to notify users; in addition, all recall information is significant to the repair history of the device and may: a) help clarify a past intermittent problem whose cause could not be fully explained at time of occurrence or b) provide valuable information for consideration during pre-purchase evaluations.

Class I – HOSPIRA, INC., Morgan Hill, California: Manufacturer: Hospira Holdings & Costa Rica Ltd., Costa Rica. Infuser: Symbiq One and Two Channel Infuser. Class I. Firm initiated recall ongoing. Firm first notified users by letter on March 26, 2010. Volume in Commerce: 28,485 units. Reason: If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result. FDA recalls #Z-2381-2010. FDA Enforcement Report, 9/15/10.

AMD LASERS, L.L.C., Indianapolis, Indiana. Laser: Picasso/Picasso Lite Lasers for Dentistry. Class II. Firm initiated recall is ongoing. Firm notified users by letters dated April 30, 2010. Volume in Commerce: 3,000 units. Reason: Product is noncompliant with the Federal laser product performance standard in certain requirements. The ON/OFF key on some of the lasers could be removed with force while the key was in the ON position. FDA recall #Z-2349-2010. FDA Enforcement Report, 09/15/10.

GE HEALTHCARE, LLC, Waukesha, Wisconsin: Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, Wisconsin. Monitor: Carescape TM Monitor B850. Class II. Firm initiated recall ongoing. Firm first notified users by letter July 12, 2010. Volume in Commerce: 875 units. Reason: GE is aware of four safety issues: 1) Loss of user input when using certain displays or the USB remote control; 2) Potential for a delay in treatment or missed alarm when the alarm light is used as a primary alarm source and audible alarms are turned down or off; 3) Will not use user entered hemoglobin values when calculating SvO values, which could result in incorrect treatment of a patient; 4) When used in conjunction with Tram, the HR Alarm Limits may revert back to default settings which could result in a missed alarm. There were no reported patient injuries or illnesses. FDA recall #Z-2275-2010. FDA Enforcement Report, 09/01/10.

HOSPIRA, INC., Lake Forest, Illinois: Manufacturer: Modo Inc., Beaverton, Oregon. Accessory Power Pack: a 4 outlet power strip with a custom pole clamp bracket to attach to the IV pole with the infusion pump, part number 39003-04-01, Modo #HSP1700, Model Tripp-Lite PS-415-HG Accessory power pack used with medical devices. Class II. Firm initiated recall ongoing. Firm first notified users by letters dated July 1, 2010. Volume in Commerce: 1,766 units. Reason: The Power Pack Accessory is not certified to UL 60601 standard or Subject 1363A for relocatable power taps intended for use with medical equipment. Potential problems could include electrical shock, electrical short, or electrical fire. FDA recalls #Z-2234-2010. FDA Enforcement Report, 9/15/10.

INVACARE CORP., Sanford, Florida. Hospital Bed: AC-Powered Adjustable Hospital Bed Model 5890 IVC and 5490 IVC. Class II. Firm initiated recall is ongoing. Firm notified users by letter on October 18, 2006. Volume in Commerce: 731 units. Reason: Invacare Corporation issued a device correction in October 2006 for the IVC Bed Foot Actuator used on the IVC Bed series. The actuators were not in the fully extended position and could not be mounted onto the beds. All affected consignees were notified of this correction in October 2006. FDA recall #Z-2393-2010. FDA Enforcement Report, 09/15/10.

INVACARE CORP., Sanford, Florida. Hospital Bed Mattresses: CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series of manual, semi-electric, and electric beds. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated October 15, 2007. Volume in Commerce: 19,143 units. Reason: These mattresses when used in combination with the IVC and ValueCare Series of manual, semi-electric, and electric beds and associated bed rails do not meet some of the requirements of the voluntary FDA Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment as intended. Use of these particular mattresses in combination with Invacare beds and bed rails may put the users at increased risk of entrapment. FDA recall #Z-2402-2010. FDA Enforcement Report, 09/15/10.

INVACARE CORP., Sanford, Florida. Hospital Bed Mattresses: Mattress Model 5185 and 5185XL. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated September 5, 2007. Volume in Commerce: 4,896 units. Reason: These mattresses when used in combination with the IVC and ValueCare Series of manual, semi-electric, and electric beds and associated bed rails do not meet some of the requirements of the voluntary FDA Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment as intended. Use of these particular mattresses in combination with Invacare beds and bed rails may put the users at increased risk of entrapment. FDA recall #Z-2403-2010. FDA Enforcement Report, 09/15/10.

PHYSIO-CONTROL, INC., Redmond, Washington. Defibrillator Paddles: 1) External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 12 and LIFEPAK 20/20e; 2) Pediatric attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 12 and LIFEPAK 20/20e. Class II. Firm initiated recall complete. Firm notified users by letter on November 14, 2008. Volume in Commerce: 39,910 units. Reason: Sterilization efficacy could not be confirmed for sterilization methods on External Sterilization Paddles and Pediatric attachments. FDA recalls #Z-2311/2312-2010. FDA Enforcement Report, 09/15/10.

SIEMENS MEDICAL SOLUTIONS, USA, INC., Malvern, Pennsylvania: Manufacturer: Siemens AG Medical Solutions, INC., Forchheim, Germany. X-Ray: Axiom Artis MP/Artis dMP and Artis zee Multipurpose Angiographic X-ray System. Class II. Firm initiated recall ongoing. Firm first notified users by letter July 13, 2010. Volume in Commerce: 131 units. Reason: If the Multipurpose C-arm gearbox is damaged, the C-arm may tilt away when being repositioned and collide with nearby objects in its range of motion. FDA recall #Z-2233-2010. FDA Enforcement Report, 09/01/10.

STRYKER INSTRUMENTS DIVISION OF STRYKER CORP., Kalamazoo, Michigan. Bur Guard: intended for use with the Impaction Drill. Replace by dates of May 2009 through August 2010. Class II. Firm initiated recall ongoing. Firm notified users by letter dated June 10, 2010. Volume in Commerce: 10,982 units. Reason: The inner diameter of the Bur Guards may be out of specification. If there is excess material on the inside of the Bur Guard at the location where the guard tapers, it may come into contact with the Nose Cone of the drill. This could result in an injury or burn to the patient and/or user. FDA recall #Z-2420-2010. FDA Enforcement Report, 09/15/10.

STRYKER MEDICAL DIVISION OF STRYKER CORP., Portage, Michigan. Stretchers With Crank: 1) Eye surgery stretcher with crank fowler, # model 1069; 2) Eye surgery stretcher with crank fowler #1079; 3) Service parts for Crank Screw Assembly. Class II. Firm initiated recall ongoing. Firm notified users by letters dated February 26, 2010. Volume in Commerce: 1,640 units – 1,128 nationally. Reason: The fowler of the bed is raised by a crank. The crank consists of a steel screw that moves through a brass nut. Over time the screw can wear the thread on the brass nut, and the screw and the nut can become mis-aligned, causing a loud squealing noise when the screw comes in contact with the drive tube. In addition the fowler can become inoperable over time with the excessive wear of the brass nut. This may delay care for a patient who requires the fowler to be raised.FDA recalls #Z-2341/2343-2010. FDA Enforcement Report, 09/15/10.

ZIMMER, INC., Warsaw, Indiana: Manufacturer: Zimmer Spine Austin Inc., Austin, Texas. Screwdriver: Abbott Spine PathFinder, Cannulated Poly Screwdriver II. Class II. Firm initiated recall is ongoing. Firm notified users by letter on April 6, 2010. Volume in Commerce: 691 units. Reason: The screw driver may fracture, resulting in surgical delays and/or fragments going into the surgical area. FDA recall #Z-2335-2010. FDA Enforcement Report, 09/15/10.