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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Product Detail

Product Description Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
Recall Number Z-1669-2013
Classification Class II
Code Info 510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03
Product Distributed Qty 657 units
Reason For Recall Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.

Event Detail

Event Id 65462
Product Type Devices
Status Ongoing
Recalling Firm Cardio Medical Products
City Rockaway
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution
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