Recall Z-1431-2010 ยท DRX Electrode, Electrocardiograph
ConvaTec
Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring
| Date | Apr 22, 2010 (initiated Mar 11, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | 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 r |
| Quantity | 567,000 units |
| Distribution | Nationwide distribution: CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990113 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 Maersk Medical A/S, Dec 6, 1999 |