Device recall
Z-0150-2010: ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes…
FDA device recall · Class II · Sendx Medical Inc
Key facts
| Recall number (Z-number) | Z-0150-2010 |
|---|---|
| Recall event | 52791 |
| Product | ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is… |
| Product code | CHL |
| Recalling firm | Sendx Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 16, 2012 |
| 510(k) numbers | K080370 |
| FEI number | 2027541 |
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