||May 30, 2013
||adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1.
Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.
||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.
|TZ Medical Inc.
17750 SW Upper Boones Ferry Rd Ste 150
Portland, Oregon 97224-7086
|For Additional Information Contact
||Mr. John Lubisich
|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
||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.
|Quantity in Commerce
||US: 10,410 pieces; Outside US: 100 pieces
||Worldwide distribution - USA (nationwide) and Chile.