Device recall
Z-1075-2014: pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-1075-2014 |
|---|---|
| Recall event | 67066 |
| Product | pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes. |
| Product code | CHL |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 19, 2015 |
| 510(k) numbers | K041874, K980130 |
| FEI number | 1523456 |
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