Agency classClass IIOur severity:High FDA (Devices)·Z-1438-2013·Announced 2013-06-05

TZ Medical Recalls Defibrillation Electrodes Due to Defective White Wire

TZ Medical Inc. is recalling P-211-M1 and P-214-M1 defibrillation electrodes because they may contain a defective white wire on the connector assembly.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for life-critical procedures (defibrillation/pacing) with a potential functional defect, but the source text does not report any injuries, illnesses, or fatalities, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

TZ Medical Inc. is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes. The recall is being conducted because the products may contain a defective white wire on the connector assembly.

These disposable electrodes are used by trained professionals in hospitals, doctors' offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion, and monitoring. The affected units were distributed nationwide in the United States and in Chile.

If a failure occurs, the end user can identify the issue by inspecting the white wire located 1/4 inch from the Gray Medtronic / Physio adapter. Consignees will notice discoloration on the wire. Users should inspect their equipment for this specific defect.

The recalled product

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…
Manufacturer: TZ Medical Inc.
Category: Medical Device — Defibrillation Electrodes
Hazard: electrical-failure
device-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

Model P-211-M1 Lot numbers: Y081712-17
Y081712-18
Y081712-19
Y081712-20
Y112612-08
Y112612-09
Y112612-10
Y112612-11
Y112612-12
Y112612-13
and Y020113-07. Model P-214-M1 Lot numbers: Y081712-04
Y112612-24
Y112612-23
and Y031913-10.

Distribution

Distributed nationwide across the United States.

Same manufacturer · TZ Medical Inc.

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Same hazard · electrical failure