Recall Z-1438-2013 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
TZ Medical Inc.
adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.
| Date | May 30, 2013 (initiated Apr 30, 2013) |
| Status | Terminated |
| Reason | TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. If a failure were to occur, the end user would be able to identify the failure by inspecting the white wire 1/4 inch from the Gray Medtronic / Physio adapter. The consignees will notice discolor |
| Root cause | Process control |
| Action | TZ Medical Inc. started notifying their customers by telephone on April 30, 2013. The firm followed up with an Urgent: Medical Device Recall notification letter dated May 14, 2013, to their consignees. TZ Medical Inc., Representatives have will contact all affected customers and arrange for the replacement of the effected product in stock with inspected product. For any questions about this recall, please fax to 503-639-0239. |
| Quantity | US: 10,410 pieces; Outside US: 100 pieces |
| Distribution | Worldwide distribution - USA (nationwide) and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983196 | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) Tz Medical, Inc., Sep 15, 1999 |