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U.S. Department of Health and Human Services

Class 2 Device Recall Myocardial Heart Wires

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  Class 2 Device Recall Myocardial Heart Wires see related information
Date Initiated by Firm July 25, 2012
Date Posting Updated October 29, 2012
Recall Status1 Terminated 3 on December 17, 2013
Recall Number Z-0165-2013
Recall Event ID 63112
510(K)Number K831695  
Product Classification Electrode, pacemaker, temporary - Product Code LDF
Product Myocardial Heart Wires

Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
Code Information Model Number TME60S, Lot #C1-07101, Model Number TME64S, Lot #C1-07056, Model Number TME64S, Lot #C1-07057, Model Number TME64S, Lot #C1-07058, Model Number TME64S, Lot #C1-07111, Model Number TME64S, Lot #C1-07112, Model Number TME64S, Lot #C1-07113, Model Number TME64S, Lot #C1-07114, Model Number TME64S, Lot #C1-07122, Model Number TME64S, Lot #C1-07123, Model Number TME64S, Lot #C1-07124, Model Number TME64S, Lot #C1-07125, Model Number TME64C, Lot #C1-07143, Model Number TME64S, Lot #C1-07151, Model Number TME64S-3, Lot #C1-07156, Model Number TME65S, Lot #C1-07174

Recalling Firm/
Manufacturer
Oscor, Inc.
3816 Desoto Boulevard
Palm Harbor FL 34683-1618
For Additional Information Contact Mila Doskocil
727-937-2511 Ext. 133
Manufacturer Reason
for Recall
Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification.
FDA Determined
Cause 2
Process control
Action Oscor sent a customer notification letter dated July 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to send the listed models and lots in their inventory back to the recalling firm for immediate replacement. They were also instructed to call Oscor Customer Service at 727-937-2511 to obtain a Return Goods Product (RGA) number. For questions regarding this recall call 727-937-2511, ext. 133.
Quantity in Commerce 1425
Distribution Worldwide Distribution - USA including OR, FL, Al, TX, NM, CA, AL, PA, KY, IN, OH, and IL and internationally to Canada, Russia, and New Zealand
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 = LDF and Original Applicant = Oscor Inc.
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