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U.S. Department of Health and Human Services

Class 2 Device Recall Medstrom Adult Radiolucent LeadsOut Electrode

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  Class 2 Device Recall Medstrom Adult Radiolucent LeadsOut Electrode see related information
Date Initiated by Firm December 05, 2008
Date Posted April 12, 2011
Recall Status1 Terminated 3 on April 13, 2011
Recall Number Z-1951-2011
Recall Event ID 57815
510(K)Number K080421  
Product Classification Multi-Function Electrocardiograph Electrode - Product Code MLN
Product Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO.

Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.
Code Information Lot Number: Y111208-6.
Recalling Firm/
Heart Sync, Inc
5643 Plymouth Rd
Ann Arbor MI 48105-9586
For Additional Information Contact Stephen Shulman
Manufacturer Reason
for Recall
The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.
FDA Determined
Cause 2
Equipment maintenance
Action The firm sent a recall notice to their distributors on 12/3/2008 asking them to quarantine product and return it to HeartSync. The letter stated that customers' current inventory would be exchanged for new product. Customers were to call 1-800-828-4681 to provide the necessary information.
Quantity in Commerce 50 (5 cases of 10 each)
Distribution Nationwide Distribution
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 = MLN and Original Applicant = HEART SYNC LLC