Recall Z-1380-04 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Bio-Detek, Inc.
Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-2065
| Date | Aug 18, 2004 (initiated Jul 30, 2004) |
| Status | Terminated |
| Reason | Pads may fail due to excessive corrosion of the electrode prior to the expiration date |
| Root cause | Other |
| Action | Biotek notified Zoll Medical Corp Zoll notified their customers by letter dated 7/28/04. Users are requested to discard electrodes and return an acknowledgement form. Recalled product will be replaced. |
| Quantity | 9.971 pairs |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915159 | PEDIATRIC MULTI-FUNCTION ELECTRODES Zmi Corp., Feb 7, 1992 |