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U.S. Department of Health and Human Services

Class 2 Device Recall Medsolutions4U MultiFunction Electrodes

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  Class 2 Device Recall Medsolutions4U MultiFunction Electrodes see related information
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/
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

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.