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June 2010 vol. 19:08

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.

FDA Posting 6/9/10; updated 6/14/10 and classified as Class I:

Company – Defibtech LLC, Guilford, Connecticut. Product – DBP-2800 Battery Pack for ReviveR AED™ and Lifeline AED® Semi-automatic External Defibrillators. BackgroundAffects only DBP-2800 battery packs distributed prior to June 4, 2007 and used with the ReviveR AED™ and Lifeline AED® devices. S/N s between 202001005 and 202005916, or, between 206001001 and 206009871 and totaling 5,418 battery packs.

Reason for Recall: If the AED is used with an affected battery pack, the AED may falsely detect an error condition, cancel charge and not provide therapy.

In a letter to customers dated May 20, 2010, Defibtech announced a mailing to all affected customers a battery pack update data card that would allow them to update device software to correct the problem while allowing the devices to remain in their locations.

FDA Comments: The following are Defibtech's immediate recommendations

  • Determine if your battery pack is affected by this correction by following the steps on the company website.
  • If your battery pack is affected by this correction, keep your DDU-100 series AED and battery in service until you have received your battery pack update card from Defibtech and have updated your battery pack. Make sure that you have a replacement battery pack available, and arrange for a backup AED if you do not have a replacement battery pack available.
  • If during a rescue, your AED cancels shock and shuts down with a service code 1003, replace the battery pack and proceed with the rescue. If this condition occurs, the AED containing an affected DBP-2800 battery pack will announce "Shock Cancelled", "Service Code 1003", "Powering Off".
  • If your battery pack is not affected by this correction, keep your DDU-100 series AED and battery in service and maintain it in accordance with the User Manual.

Contact – Defibtech Technical Support at techsupport@defibtech.com or call 1-877-453-4507 or 1-203-453-4507, 8:30 A.M. to 5:00 P.M. (Eastern Time), Monday – Friday.

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ABBOTT DIABETES CARE, INC., Alameda, California: Manufacturer: Benchmark Electronics, Rochester, Minnesota. Glucose Monitoring Systems: Freestyle Navigator Continuous Monitoring System: 20 Product Codes. Class II. Firm initiated recall is ongoing. Firm notified users by letters on April 14, 2009. Volume in Commerce: 5,449 units: California, Florida, Massachusetts, Minnesota, Mississippi, New Jersey, New York. Reason: Potential failure or inaccurate readings – the device's plastic housing near the battery compartment may crack and allow moisture to enter. FDA recalls #Z-0820/0821-2010; #Z-1444/1461-2010. FDA Enforcement Report, 05/19/10.

ABBOTT LABORATORIES, Santa Clara, California. Hematology Analyzers: 1) Cell-Dyn 1700; 2) Cell-Dyn 1700CS (closed sampler); 3) Cell-Dyn 1800. Class II. Firm initiated recall is ongoing. Firm notified users by letters beginning June 8, 2009. Volume in Commerce: 4,114 units. Reason: Use of Syringe LN 04H36-01 with the die-cast syringe may result in leakage, leading to delay in reporting results. FDA recalls #Z-1628/1630-2010. FDA Enforcement Report, 06/16/10.

ABBOTT POINT OF CARE INC., Princeton, New Jersey. I-STAT Cartridges: 1) I-STAT ACT Celite Cartridges; 2) -STAT ACT Kaolin Cartridges. Class II. Firm initiated recall is ongoing. Firm notified users by letter beginning August 18, 2009. Volume in Commerce: 696,675 Celite Cartridges and 1,110,775 Kaolin Cartridges. Reason: Label discrepancy: The manual instruction state that the lines should be flushed with 5 ml of saline and the first 5ml of blood or six dead space volumes should be discarded. The Cartridge Information Sheet states it should be 2 ml of blood – which is incorrect. FDA recalls #Z-0813/0814-2010. FDA Enforcement Report, 06/16/10.

CARESTREAM HEALTH, INC., Rochester, New York: Manufacturer: Carestream Health, Inc., White City, Oregon. X-Ray Film: 1) KODAK T-MAT L/RA Film, Catalog # 181 4631; 2) KODAK T-MAT G/RA, Catalog 151 0023. Class III. Firm initiated recall ongoing. Firm notified users by letters beginning on March 11, 2010 and by e-mail beginning March 12, 2010. Volume in Commerce: 1,435 units. Reason: Product mix-up. The firm received a customer complaint indicating the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it was performing like T-MAT G/RA. FDA recalls #Z-1314/1315-2010. FDA Enforcement Report, 06/16/10.

ELEKTA, INC., Norcross, Georgia: Manufacturer: Elekta Oncology Systems, United Kingdom. Precise Treatment Table. Class II. Firm initiated recall is ongoing. Firm notified users by Mandatory Field Change Order dated January 11, 2007. Volume in Commerce: 185 units. Reason: In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to operate the powered table. FDA recall #Z-1432-2010. FDA Enforcement Report, 05/19/10.

GE HEALTHCARE LLC, Waukesha, Wisconsin: Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Imaging Systems: 1) Cardiovascular System Innova 4100 IQ, 4100/4100Q; 2) Cardiovascular System Innova 3100 IQ, 3100/3100; 3) Digital Fluoroscopic System Innova 2100 IQ. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated March 23, 2010. Volume in Commerce: 195 units. Reason: Potential software failure affecting Wordlist functionality and possibility of exam failure and inability to recall acquired sequences. FDA recalls #Z-1659/1661-2010. FDA Enforcement Report, 06/02/10.

LEICA MICROSYSTEMS, INC., Bannockburn, Illinois: Manufacturer: Leica Microsystems (Schweiz) Ag, Heerbrugg, Switzerland. Footswitch: 1) Leica Footswitch, Type B – three cable connection footswitch; 2) Leica Wireless Footswitch, Type B – two wireless models. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated March 29, 2010. Volume in Commerce: 294 units. Reason: The pedals of the Footswitch Type B stick and the Zoom/Focus move to the end position. FDA recalls #Z-1632/1633-2010. FDA Enforcement Report, 05/26/10.

OHIO MEDICAL CORPORATION, Gurnee, Illinois. Wound Care Pump: 1) MobiVac Portable Wound Care Pump; 2) NPWT Small Mobile Bag No Logo – an adjunct to the Wound care Pump. Class II. Firm initiated recall is ongoing. Firm notified users by letters dated May 5, 2010, May 10, 2010, May 13, 2010, and May 14, 2010 and telephone on May 11, 2010. Volume in Commerce: 375 pumps and 218 bags. Reason: Ohio Medical has received a report of an explosive event with a MobiVac housing where parts were separated while in an enclosed nylon transport bag during use. FDA recalls #Z-1777/1778-2010. FDA Enforcement Report, 06/09/10.

PHILIPS HEALTHCARE INC., Andover, Massachusetts. Defibrillator/Monitor: HeartStart MRx (Models M3535A, M3536A, and M3536 used with Philips 14.8 Lithium Ion Battery. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated March 4, 2010. Volume in Commerce: 37,674 units. Reason: Batteries older than 2 years have a higher potential for intermittent electrical contact and may contribute to an interruption in monitoring or therapy if the device is operating on battery. FDA recall #Z-1317-2010. FDA Enforcement Report, 06/16/10.

PRECISION MEDICAL, INC., Northampton, Pennsylvania. Flow Selector: PM1000 – An accessory to an emergency ventilator (resuscitator). Class II. Firm initiated recall is ongoing. Firm notified users by letters dated March 5, 2010. Volume in Commerce: 1,361 units. Reason: The on/off outlet is mislabeled so that when a user/operator turns selector to “on”, it actually may be turned “off”. FDA recall #Z-1561-2010. FDA Enforcement Report, 05/26/10.

STRYKER COMMUNICATIONS CORP., Flower Mound, Texas. Surgical Lights and Controls: 1)Stryker VISUM LED Surgical Lights; 2) Stryker Equipment Delivery System (EDS) – Ceiling Mounted Equipment Booms; 3) Stryker VISUM Halogen Surgical Lights; 4) SwitchPoint Elements (SPE) Control System; 5) SwitchPoint Infinity (SPI) Control System; 6) Ceiling Suspensions. Class II. Firm initiated recall ongoing. Firm notified users by letter dated April 15, 2010. Volume in Commerce: 270 SwitchPoint Infinity, 9 SwitchPoint Element, and 608 Booms. Reason: Installations records are incomplete. FDA recalls #Z-1640/1645-2010. FDA Enforcement Report, 06/02/10.

ZOLL MEDICAL CORPORATION, Chelmsford, Massachusetts. Defibrillator/Pacer/Monitor: Zoll E series, BLS Model with software versions 4.XX, 6.XX, and 7.0X. Class II. Firm initiated recall ongoing. Firm notified users by letter dated March 26, 2010. Volume in Commerce: 1,383 units. Reason: Device issued “Shock Advised” message but failed to auto-charge the defibrillator. FDA recall #Z-1547-2010. FDA Enforcement Report, 05/19/10.