Device recall
Z-2571-2011: Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-2571-2011 |
|---|---|
| Recall event | 58657 |
| Product | Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) membranes per box. Calcium membrane jackets that are used in the ABL505/555, EML105, ABL600, ABL700… |
| Product code | JFP |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 19, 2012 |
| 510(k) numbers | K043218, K914166, K954612, K962334, K974818, K980130 |
| 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