Device recall
Z-0896-2020: CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its…
FDA device recall · Class II · Haemonetics Corporation
Key facts
| Recall number (Z-number) | Z-0896-2020 |
|---|---|
| Recall event | 84183 |
| Product | CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. |
| Product code | CAC |
| Recalling firm | Haemonetics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 6, 2020 |
| 510(k) numbers | K101907 |
| FEI number | 1219343 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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