Class II — Cardio Medical Products
| Recalling firm | CARDIO MEDICAL PRODUCTS, INC. |
|---|---|
| Registered facility | CARDIO MEDICAL PRODUCTS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 657 units |
| Distribution | Nationwide Distribution |
| Initiated | 2013-04-26 |
| Classified | 2013-07-08 |
| Terminated | 2016-08-15 |
| Recall number | Z-1669-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cardio Medical Products (Z-1669-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65462/
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