FDAFDA · Food and drugs·Recall number Z-1669-2013
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
Published July 17, 2013 · Recall initiated: April 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardio Medical Products
- Distributor
- Nationwide Distribution
- Lot
- 510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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