Device recall
Z-1540-2009: i-STAT EG7+ Cartridge; pH, PCO, PO, Na, K, iCa, Hct. Test include: Electrode…
FDA device recall · Class III · Abbott Point of Care Inc.
Key facts
| Recall number (Z-number) | Z-1540-2009 |
|---|---|
| Recall event | 51211 |
| Product | i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300. Abbott Point of Care inc… |
| Product code | CHL |
| Recalling firm | Abbott Point of Care Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 29, 2009 |
| 510(k) numbers | K894914, K912387, K934642, K940918 |
| FEI number | 2245578 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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