Device recall
Z-1310-2022: TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
FDA device recall · Class II · Haemonetics Corporation
Key facts
| Recall number (Z-number) | Z-1310-2022 |
|---|---|
| Recall event | 90323 |
| Product | TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 |
| Product code | JPA |
| Recalling firm | Haemonetics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 15, 2024 |
| 510(k) numbers | K002177 |
| FEI number | 1219343 |
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