Device recall
Z-1384-2012: SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System…
FDA device recall · Class II · Sendx Medical Inc
Key facts
| Recall number (Z-number) | Z-1384-2012 |
|---|---|
| Recall event | 61178 |
| Product | SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians… |
| Product code | CHL |
| Recalling firm | Sendx Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2012 |
| 510(k) numbers | K051804 |
| 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