| ||Class 2 Recall|
Myocardial Heart Wires
||October 29, 2012
||Myocardial Heart Wires
Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
||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
3816 Desoto Boulevard
Palm Harbor, Florida 34683-1618
||Contact the recalling firm for information
|For Additional Information Contact
727-937-2511 Ext. 133
|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.
||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
||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