Device recall
Z-1341-2011: Celite ACT Cartridge Cartridge is useful for monitoring patients receiving…
FDA device recall · Class II · Abbott Point Of Care Inc.
Key facts
| Recall number (Z-number) | Z-1341-2011 |
|---|---|
| Recall event | 57454 |
| Product | Celite ACT Cartridge Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery organ transplantation… |
| Product code | JBP |
| Recalling firm | Abbott Point Of Care Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 16, 2013 |
| 510(k) numbers | K992571 |
| FEI number | 2245578 |
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