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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Event Detail

Event ID 63112
Product Type Devices
Status Ongoing
Recalling Firm Oscor, Inc.
City Palm Harbor
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-25
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Class II 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. 1425 Z-0165-2013
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