Device recall
Z-1738-2011: TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for…
FDA device recall · Class II · Haemoscope Division of Haemonetics Corp
Key facts
| Recall number (Z-number) | Z-1738-2011 |
|---|---|
| Recall event | 57809 |
| Product | TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 a multipurpose system for in vitro coagulation studies |
| Product code | JPA |
| Recalling firm | Haemoscope Division of Haemonetics Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 12, 2012 |
| 510(k) numbers | K002177 |
| FEI number | 2429444 |
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