Recall Z-1669-2013— Cardio Medical Products

Name: FDA recall Z-1669-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-26

Class II · Terminated

Class II FDA medical device recall by Cardio Medical Products, initiated 2013-04-26, terminated 2016-08-15. It names one FDA 510(k) clearance: K103159. Product: 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..

Recalling firm: Cardio Medical Products
Classification: Class II
Status: Terminated
Initiated: 2013-04-26
Terminated: 2016-08-15
Firm location: Rockaway, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K103159 — CARDIO MED MODEL A102, H104, O101, P103, AND Z100Cardio Medical Products, Inc.·cleared 2011-01-11

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

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.

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