GMP Companies/Lifesync Corporation LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223
Brand
GMP Companies/Lifesync Corporation
Lot Codes / Batch Numbers
C6310, C6324 and C6297.
Products Sold
C6310, C6324 and C6297.
GMP Companies/Lifesync Corporation is recalling LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026