Home / Recalls / TZ Medical Inc. / Z-1438-2013

Z-1438-2013 Class II Terminated

Recalled by TZ Medical Inc. — Portland, OR

Recall Details

Product Type: Devices
Report Date: June 5, 2013
Initiation Date: April 30, 2013
Termination Date: September 5, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: US: 10,410 pieces; Outside US: 100 pieces

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

Distribution Pattern

Worldwide distribution - USA (nationwide) and Chile.

Code Information

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.