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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Life Sync Leadwear Disposable		see related information
Date Posted February 27, 2007
Recall Number Z-0546-2007
Product LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223
Code Information C6310, C6324 and C6297.
Recalling Firm/
Manufacturer		 GMP Companies/Lifesync Corporation
One E. Broward Blvd.
Suite 1701
Ft Lauderdale, Florida 33301
Reason for
Recall		 When the V-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. If the product is used during a defibrillation after such a de-lamination, it could burn the skin and may compromise the efficacy of the defibrillation.
Action The recall was initiated on January 15, 2007. The firm''s representatives, hand carried, Device Recall Letter to Account Representative and Risk Manager. Distributors who received the Device Recall Letter, purged their stock of the affected devices and notified their customers. Recall Communication was hand carried to each account with 100% compliance by LifeSync Clinical/Sales Personnel. EFFECTIVENESS CHECKS of this recall will be achieved through Return Material Authorization via telephone with each affected account.
Quantity in Commerce 272 cases
Distribution Nationwide
 
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