Device recall
Z-0195-2013: ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35)…
FDA device recall · Class II · Sendx Medical Inc
Key facts
| Recall number (Z-number) | Z-0195-2013 |
|---|---|
| Recall event | 63368 |
| Product | ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses… |
| Product code | CHL |
| Recalling firm | Sendx Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 5, 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