adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usag
FDA device recall Z-1438-2013 · posted 2013-05-30 · Terminated
Recall details
- Recalling firm
- TZ Medical Inc.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DRO
- Quantity affected
- US: 10,410 pieces; Outside US: 100 pieces
- Distribution
- Worldwide distribution - USA (nationwide) and Chile.
- Date initiated
- 2013-04-30
- Date posted
- 2013-05-30
- Date terminated
- 2013-09-05
- Location
- Portland, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (K983196) | Tz Medical, Inc. | 1999-09-15 |