Reported Jul 17, 2013 · Terminated
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single…
Cardio Medical Products
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardio Medical Products · 385 Franklin Ave · Rockaway, NJ · 07866-4037
Is this the product you have?
- 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
- Lot codes and dates
- 510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03
- Amount recalled
- 657 units
Where it was sold
- Nationwide
Why it was recalled
Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.
This product could cause temporary or reversible health problems — stop using it.
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