Class II — TZ Medical Inc.
| Recalling firm | TZ MEDICAL, INC. |
|---|---|
| Registered facility | TZ MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| 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 |
| Product | 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. |
| Quantity | US: 10,410 pieces; Outside US: 100 pieces |
| Distribution | Worldwide distribution - USA (nationwide) and Chile. |
| Initiated | 2013-04-30 |
| Classified | 2013-05-30 |
| Terminated | 2013-09-05 |
| Recall number | Z-1438-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — TZ Medical Inc. (Z-1438-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65120/
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