Recall Z-0165-2013— Oscor, Inc.

Name: FDA recall Z-0165-2013
Creator: U.S. Food and Drug Administration
Published: 2012-07-25

Class II · Terminated

Class II FDA medical device recall by Oscor, Inc., initiated 2012-07-25, terminated 2013-12-17. It names one FDA 510(k) clearance: K831695. 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.. Reason: 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..

Recalling firm: Oscor, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-25
Terminated: 2013-12-17
Firm location: Palm Harbor, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K831695 — TEMP. CARDIAC PACING WIRE TME 60/61/65Oscor, Inc.·cleared 1983-10-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.