Device recall
Z-0374-2008: Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct)…
FDA device recall · Class II · Abbott Point of Care Inc.
Key facts
| Recall number (Z-number) | Z-0374-2008 |
|---|---|
| Recall event | 44972 |
| Product | Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No: 12500; Abbott Point of Care Inc., East Windsor, NJ 08520, USA; Product of Canada. |
| Product code | JGS |
| Recalling firm | Abbott Point of Care Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 18, 2008 |
| 510(k) numbers | K001154, K894914, K912387, K936081 |
| 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