Device recall
Z-2950-2018: Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT…
FDA device recall · Class II · Haemonetics Corporation
Key facts
| Recall number (Z-number) | Z-2950-2018 |
|---|---|
| Recall event | 80740 |
| Product | Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures |
| Product code | CAC |
| Recalling firm | Haemonetics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2020 |
| 510(k) numbers | K992723 |
| 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