Device recall
Z-0713-2014: pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-0713-2014 |
|---|---|
| Recall event | 67044 |
| Product | pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen). |
| Product code | CHL |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 19, 2014 |
| 510(k) numbers | K895181, K922922, K935655 |
| 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