FDA Enforcement
Class II
Terminated
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: Z-1669-2013
·
Reported July 17, 2013
Enforcement
- Recall Number
- Z-1669-2013
- Event ID
- 65462
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cardio Medical Products
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 17, 2013
- Initiation Date
- April 26, 2013
- Classification Date
- July 8, 2013
- Termination Date
- August 15, 2016
- Address
- 385 Franklin Ave, N/A, Rockaway, NJ, 07866-4037, United States
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
Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.
Code Info
510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03
Distribution
Nationwide Distribution
Quantity
657 units