Device recall
Z-1669-2013: Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or…
FDA device recall · Class II · Cardio Medical Products
Key facts
| Recall number (Z-number) | Z-1669-2013 |
|---|---|
| Recall event | 65462 |
| 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… |
| Product code | LDD |
| Recalling firm | Cardio Medical Products |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2016 |
| 510(k) numbers | K103159 |
| FEI number | 2246340 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database