FDA Device recall Z-1669-2013
Cardio Medical Products, Inc
- FDA Device
- Class II
- terminated
- Published 2013-07-17
On 2013-07-17 the FDA classified a Class II recall of Cardio Medical Products, Inc by Cardio Medical Products, citing covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1669-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-26 |
| Published | 2013-07-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cardio Medical Products |
| Distribution | US |
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 (973) 586-9624 FAX Defibrillator
Reason
Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.
Identifiers
| code_info | 510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1669-2013%22
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