Device recall
Z-1015-2010: Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-1015-2010 |
|---|---|
| Recall event | 51983 |
| Product | Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box. |
| Product code | CGL |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 9, 2012 |
| 510(k) numbers | K051968 |
| FEI number | 1523456 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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