Recall record at a glance
| Official record | Z-0938-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Alung Technologies Inc. |
| Report date | Feb 10, 2021 |
| Recall initiation date | Dec 18, 2020 |
| Quantity | 101 units |
| Location | Pittsburgh, PA, United States |
Official product description
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.
Why the product was recalled
CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy
Distribution information
US Nationwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.