Recall Z-1438-2013— TZ Medical Inc.

Name: FDA recall Z-1438-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-30

Class II · Terminated

Class II FDA medical device recall by TZ Medical Inc., initiated 2013-04-30, terminated 2013-09-05. It names one FDA 510(k) clearance: K983196. 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: 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.

Recalling firm: TZ Medical Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-04-30
Terminated: 2013-09-05
Firm location: Portland, OR, United States

510(k) clearances named in this recall

1 on FDA's record

K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.·cleared 1999-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.