LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223
FDA Recall Z-0546-2007 · Posted 2007-02-27
Recalling FirmGMP Companies/Lifesync Corporation
Recall StatusTerminated
Product CodeDRG
Date Initiated2007-01-10
Date Terminated2009-07-27
Product Quantity272 cases
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.