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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic/Physio Control Transparent Defibrillation Electrodes

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 Class 2 Recall
Medtronic/Physio Control Transparent Defibrillation Electrodes
see related information
Date Posted May 30, 2013
Recall Status1 Terminated on September 05, 2013
Recall Number Z-1438-2013
Recall Event ID 65120
Premarket Notification
510(K) Number
K983196 
Product Classification Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) - Product Code DRO
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.
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.
Recalling Firm/
Manufacturer
TZ Medical Inc.
17750 SW Upper Boones Ferry Rd Ste 150
Portland, Oregon 97224-7086
For Additional Information Contact Mr. John Lubisich
503-639-0282
Manufacturer 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 2
PRODUCTION CONTROLS: Process Control
Action 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
Distribution Worldwide distribution - USA (nationwide) and Chile.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DRO and Original Applicant = TZ MEDICAL, INC.
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