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U.S. Department of Health and Human Services

Class 2 Device Recall Life Sync Leadwear Disposable

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 Class 2 Device Recall Life Sync Leadwear Disposablesee related information
Date Initiated by FirmJanuary 10, 2007
Date PostedFebruary 27, 2007
Recall Status1 Terminated 3 on July 27, 2009
Recall NumberZ-0546-2007
Recall Event ID 37252
510(K)NumberK030795 
Product Classification ecg component - Product Code DRG
ProductLifeSync 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 FL 33301
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce272 cases
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DRG
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