Device recall
Z-1632-2018: Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product…
FDA device recall · Class III · Michigan Instruments, Inc.
Key facts
| Recall number (Z-number) | Z-1632-2018 |
|---|---|
| Recall event | 79764 |
| Product | Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse. |
| Product code | DRM |
| Recalling firm | Michigan Instruments, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 3, 2019 |
| 510(k) numbers | K972525 |
| FEI number | 1821850 |
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