CLASS II Device recall · Reported 17 Jul 2013 · FDA Enforcement Report
Defibrillation/Cardioversion/Monophasic or Biphasic recalled
Cardio Medical Products is recalling Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode, distributed nationwide in the US. The recall was initiated on 26 Apr 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1669-2013
- FDA event ID
- 65462
- Recalling firm
- Cardio Medical Products, Rockaway, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Apr 2013
- FDA classified
- 8 Jul 2013
- Reported
- 17 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 26 Apr 2013 | Recall initiated by company | |
| 8 Jul 2013 | Classified by FDA | +73 days |
| 17 Jul 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it 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.
Which lots are affected?
510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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