Device recall
Z-1235-2017: The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide…
FDA device recall · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Recall number (Z-number) | Z-1235-2017 |
|---|---|
| Recall event | 76386 |
| Product | The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged… |
| Product code | KFM |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 23, 2017 |
| 510(k) numbers | K112229 |
| FEI number | 3000204839 |
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