Date Initiated by Firm |
April 30, 2013 |
Date Posted |
May 30, 2013 |
Recall Status1 |
Terminated 3 on September 05, 2013 |
Recall Number |
Z-1438-2013 |
Recall Event ID |
65120 |
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 OR 97224-7086
|
For Additional Information Contact |
Mr. John Lubisich 503-639-0282
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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 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = DRO and Original Applicant = TZ MEDICAL, INC.
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