FDA-Device2012-11-07Class II
Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
Oscor, Inc.
Hazard
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.
Sold states
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
Affected count
1425
Manufactured in
3816 Desoto Boulevard, N/A, Palm Harbor, FL, United States
Products
Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0165-2013Don't want to check this manually?
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