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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 Recall
Myocardial Heart Wires
see related information
Date Posted October 29, 2012
Recall Status1 Terminated on December 17, 2013
Recall Number Z-0165-2013
Recall Event ID 63112
Premarket Notification
510(K) Number
K850622 
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, Florida 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
TRAINING: Employee Error
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LDF and Original Applicant = OSCOR MEDICAL CORP.
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