Z-0938-2021Class II

ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) -

Name: Z-0938-2021 ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) -
Creator: Alung Technologies Inc
Published: 2020-12-18
License: https://open.fda.gov/license/

Alung Technologies, Inc. / initiated 2020-12-18 / Terminated / root cause: manufacturing process

FDA source

Alung Technologies Inc began a recall of ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and... on 2020-12-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0938-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-18
Posted: 2021-01-29
Terminated: 2021-05-17
Recalling firm: Alung Technologies, Inc.
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 Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: ALung issued email notification "Recalled CME BodyGuard 323 Infusion Pump to Sapphire Pump Exchange" on 12/18/20 . Letter notifies users of the CME/Sapphire Infusion Pump exchange. Provided with this email are the instructions that will come with the infusion pump package. We wanted to give you a preview of what is coming prior to the packages arriving. Once received, we ask that you promptly remove the current CME pump, package and ship back to ALung. These are needed to be returned to the manufacturer by the end of the year. Reminder you may need to contact biomed for the electrical safety testing of the new Sapphire pump! Please follow your internal protocols.
Quantity in commerce: 101 units
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0938-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0938-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-10	2021-01-29

Product code QLN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)