adult defibrillation — Class II medical device recall Z-1438-2013
Terminated recall by TZ Medical Inc., reported 2013-06-05, distributed nationwide. TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibr
| Recall number | Z-1438-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TZ Medical Inc., Portland, OR, United States |
| Recall initiated | 2013-04-30 |
| Classified | 2013-05-30 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2013-09-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL |
| Lot numbers | Y020113-07, Y031913-10, Y081712-04, Y081712-17, Y081712-18, Y081712-19, Y081712-20, Y112612-08, Y112612-09, Y112612-10, Y112612-11, Y112612-12, Y112612-13, Y112612-23, Y112612-24 |
| Model numbers | P-211-M1, P-214-M1 |
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1438-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.