Device recall
Z-1541-2009: i-STAT G3+ Cartridge; pH, PCO, PO. HCO2, TCO2, BE sO2; Test includes: PCO2 for…
FDA device recall · Class III · Abbott Point of Care Inc.
Key facts
| Recall number (Z-number) | Z-1541-2009 |
|---|---|
| Recall event | 51211 |
| Product | i-STAT G3+ Cartridge; pH, PCO, PO. HCO2, TCO2, BE sO2; Test includes: PCO2 for calculated HCO3 and PO2 for calculated oxygen saturated/sO2. Catalog Number 220100. Abbott Point of Care Inc., Abbott Park, IL 60064 The iSTAT G3+ Cartridge is intended to be used to quantitatively measure oxygen, carbon… |
| Product code | CHL |
| Recalling firm | Abbott Point of Care Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 29, 2009 |
| 510(k) numbers | 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