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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

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.
Recall Number Z-1438-2013
Classification Class II
Code Info 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.
Product Distributed Qty US: 10,410 pieces; Outside US: 100 pieces
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 discoloration in the protective plastic jacket.

Event Detail

Event Id 65120
Product Type Devices
Status Ongoing
Recalling Firm TZ Medical Inc.
City Portland
State OR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-30
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Worldwide distribution - USA (nationwide) and Chile.
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