TZ Medical Inc.: Medical Device Recall in 2013 - (Recall #: Z-1438-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 30, 2013

Date Posted: June 5, 2013

Recall Number: Z-1438-2013

Event ID: 65120

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

Status: Terminated

Product Quantity: US: 10,410 pieces; Outside US: 100 pieces

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.

Distribution Pattern:

Worldwide distribution - USA (nationwide) and Chile.

Voluntary or Mandated:

Voluntary: Firm initiated