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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 Recall
Life Sync Leadwear Disposable
see related information
Date Posted February 27, 2007
Recall Status1 Terminated on July 27, 2009
Recall Number Z-0546-2007
Recall Event ID 37252
Premarket Notification
510(K) Number
K030795 
Product Classification Transmitters And Receivers, Physiological Signal, Radiofrequency - Product Code DRG
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
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
PRODUCTION CONTROLS: Process Control
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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DRG and Original Applicant = GMP/COMPANIES, INC.
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