Device recall
Z-0938-2021: ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard…
FDA device recall · Class II · Alung Technologies Inc
Key facts
| Recall number (Z-number) | Z-0938-2021 |
|---|---|
| Recall event | 87048 |
| Product | ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing. |
| Product code | QLN |
| Recalling firm | Alung Technologies Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2021 |
| FEI number | 3009763347 |
At a glance
- None 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