Z-1669-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 17, 2013
- Initiation Date
- April 26, 2013
- Termination Date
- August 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 657 units
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
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.
Distribution Pattern
Nationwide Distribution
Code Information
510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03