Date Initiated by Firm |
March 12, 2013 |
Date Posted |
September 02, 2014 |
Recall Status1 |
Terminated 3 on June 17, 2015 |
Recall Number |
Z-2565-2014 |
Recall Event ID |
68970 |
510(K)Number |
K033771
|
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
|
Product |
Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring
Part Number: 2033 |
Code Information |
Lot #0413 Expiration Date: 2015-01-26 |
Recalling Firm/ Manufacturer |
Bio-Detek, Inc. 525 Narragansett Park Dr Pawtucket RI 02861-4323
|
For Additional Information Contact |
401-729-1400 Ext. 238
|
Manufacturer Reason for Recall |
Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Bio-Detek issued an Urgent Field Safety Notice to Medsolutions4 U on 3/12/13, informing them of the problem and actions that should be taken to remove the affected products from service. |
Quantity in Commerce |
30 cases (300 electordes) |
Distribution |
Worldwide Distribution in Germany and Slovenia. |
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.
|
510(K) Database |
510(K)s with Product Code = MKJ and Original Applicant = BIO-DETEK, INC.
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