Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1438-2013 — 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 mon

U.S. FDA — Device Enforcement · United States · 2013-04-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1438-2013
Date of alert
2013-04-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
TZ Medical Inc.
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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