Recall Z-1438-2013
TZ Medical Inc. · initiated April 30, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
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
FDA-determined cause: Process control
Action taken
TZ Medical Inc. started notifying their customers by telephone on April 30, 2013. The firm followed up with an Urgent: Medical Device Recall notification letter dated May 14, 2013, to their consignees. TZ Medical Inc., Representatives have will contact all affected customers and arrange for the replacement of the effected product in stock with inspected product. For any questions about this recall, please fax to 503-639-0239.
Details
- Recall number
- Z-1438-2013
- Initiated
- April 30, 2013
- Posted by FDA
- May 30, 2013
- Terminated
- September 5, 2013
- Product code
- DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Quantity
- US: 10,410 pieces; Outside US: 100 pieces
- Distribution
- Worldwide distribution - USA (nationwide) and Chile.
- Recalling firm
- TZ Medical Inc., Portland, OR