Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring
FDA device recall Z-1431-2010 · posted 2010-04-22 · Terminated
Recall details
- Recalling firm
- ConvaTec
- Reason for recall
- In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity.
- Action taken
- The one distributor was notified personally on March 9, 2010. All remaining stock was put on hold, and a "URGENT : MEDICAL DEVICE RECALL" letter dated March 11, 2010, was sent to customers. The letter describes the product, problem and action to be taken by customers. All customers were asked to immediately stop distributing and quarantine all recalled lots. The customers were ask to perform a count of recalled product currently in inventory, complete and return the Recall Response Form even if no recalled product is in inventory, send a copy of response to distributor in order to receive reimbursement, and to call 1-800-582-6514 for instructions on how to return the recalled product. If you have any questions, please contact Convatec at 908-904-2425.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DRX
- Quantity affected
- 567,000 units
- Distribution
- Nationwide distribution: CA
- Date initiated
- 2010-03-11
- Date posted
- 2010-04-22
- Date terminated
- 2011-06-21
- Location
- Skillman, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 (K990113) | Maersk Medical A/S | 1999-12-06 |