LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223
FDA device recall Z-0546-2007 · posted 2007-02-27 · Terminated
Recall details
- Recalling firm
- GMP Companies/Lifesync Corporation
- 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 taken
- 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
- Status
- Terminated
- Product code
- DRG
- Quantity affected
- 272 cases
- Distribution
- Nationwide
- Date initiated
- 2007-01-10
- Date posted
- 2007-02-27
- Date terminated
- 2009-07-27
- Location
- Ft Lauderdale, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFESYNE SYSTEMS (K030795) | Gmp/Companies, Inc. | 2003-08-05 |