CLASS II Device recall · Reported 10 Feb 2021 · FDA Enforcement Report
Hemolung Respiratory Assist System (RAS) recalled by Alung Technologies
Alung Technologies is recalling ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323, distributed nationwide in the US. The recall was initiated on 18 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0938-2021
- FDA event ID
- 87048
- Recalling firm
- Alung Technologies, Pittsburgh, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2020
- FDA classified
- 29 Jan 2021
- Reported
- 10 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 18 Dec 2020 | Recall initiated by company | |
| 29 Jan 2021 | Classified by FDA | +42 days |
| 10 Feb 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) recalled?
Yes. Alung Technologies recalled Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) on 18 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-0938-2021.
Why was it 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
Which lots are affected?
Serial Numbers: A11530 A11531 A11532 A11533 A11534 A11535 A11536 A11537 A11538 A11539 A11541 A11543 A11544 A11545 A11546 A11548 A11552 A11553 A11554 A11555 A11556 A11557 A11561 A11562 A11563 A11565 A11566 A11567 A11568 A11569 A11570 A11571 A11572 A11573 A11575 A11576 A11577 A11578 A11579 A11580 A11581 A11582 A11583 A11584 A11585 A11586 A11587 A11590 A11591 A11592 A16164 A16794 A16795 A16796 A16797 A16798 A16799 A16800 A16801 A16802 A16803 A16804 A16805 A16806 A16807 A16808 A16809 A16810 A16811 A16812 A16813 A16814 A16815 A16816 A16817 A16818 A16819 A16820 A16821 A16822 A16823 A16824 A16825 A16826 A16827 A34951 A34952 A34953 A34954 A34955 A34957 A34958 A34960 A34961 A34962 A34963 A34964 A34965 A34967 A34969 A34970
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |