The Recall Desk
SevereFDA (Devices)·Z-1669-2013·Announced 2013-07-17

Cardio Medical Products Defibrillator Electrodes Recalled for Arcing and Sparking

Cardio Medical Products is recalling 657 defibrillator electrodes due to reports of arcing and sparking on the leadwire.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (arcing/sparking) in a medical device that poses a risk of significant injury.

Plain-English summary

Cardio Medical Products, Inc. is recalling 657 units of Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrodes, Model Number O101. The recall was initiated after the company received customer reports of arcing and sparking on the defibrillation electrode leadwire.

The affected products are prescription-only, single-patient-use devices manufactured for Cardio Medical Products. The recall covers units distributed nationwide with part number O101 and lot numbers Y111412-2, Y111912-17, and Y020613-03. The agency has classified this as a Class II recall.

Healthcare providers and patients should stop using the affected electrodes and contact Cardio Medical Products at (800) 227-3633 for further instructions on the recall.

The recalled product

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
Manufacturer
Cardio Medical Products
Category
Medical Device — Defibrillator Electrodes
Hazard
Affected units
657

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · arcing

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