Recall Z-2334-2008 ยท MLN Electrode, Electrocardiograph, Multi-Function
Bio-Detek, Inc.
ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, and Electrocardiograph monitoring.
| Date | Sep 20, 2008 (initiated Jun 16, 2008) |
| Status | Terminated |
| Reason | Multi-function electrode programmed as a Pediatric instead of Adult |
| Root cause | Process control |
| Action | Bio-Deteck notified the own label distributor and in cooperation the firm notified their customers by letter dated 6/16/08. Users are requested to return the lots and replacement product will be provided. Zoll issued and Urgent Device Correction letter on June 16, 2008 with instructions to follow if the device is used with the defective electrodes. If you have questions, contact ZOLL Medical Technical Service at 1-800-348-9011. |
| Quantity | 25 cases of 8/cs for each lot # ; Total of 400 units |
| Distribution | MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051076 | ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES ZOLL Medical Corporation, May 13, 2005 |