FDAFDA · Food and drugs·Recall number 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 monitoring.
Published June 5, 2013 · Recall initiated: April 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- TZ Medical Inc.
- Distributor
- Worldwide distribution - USA (nationwide) and Chile.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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