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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 657
Distribution
Distributed nationwide across the United States.
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