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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/
Manufacturer		 Heart Sync, Inc
5643 Plymouth Rd
Ann Arbor MI 48105-9586
For Additional Information Contact Stephen Shulman
800-828-4681
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
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