Cardio Medical Products: Medical Device Recall in 2013 - (Recall #: Z-1669-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 26, 2013

Date Posted: July 17, 2013

Recall Number: Z-1669-2013

Event ID: 65462

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.

Status: Terminated

Product Quantity: 657 units

Code Information:

510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated