Lower risk Medical device recall · FDA · Published December 18, 2020

Alung Hemolung Respiratory Assist System with CME BodyGuard 323 Pump May Have Delivery

Alung Technologies recalls Hemolung Respiratory Assist System with CME BodyGuard 323 Infusion Pump due to potential delivery inaccuracy in saline flush. Affected units have specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0938-2021Medical device Alung Technologies ›

Lower-risk 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

Take action

Contact the company

Recalling firmAlung Technologies Inc2500 Jane St Ste 1 · Pittsburgh, PA 15203-2216

✎ GovInfoNow plain-language explainer

Alung Technologies is recalling Hemolung Respiratory Assist Systems with CME BodyGuard 323 Infusion Pumps because the pumps may deliver saline flushes inaccurately. This could lead to improper blood pump function in patients using the device. Read more at govinfonow.com/recall/63642-alung-hemolung-respiratory-assist-system-with-cme-bodyguard-323-pump.

Source Summary by GovInfoNow · govinfonow.com/recall/63642-alung-hemolung-respiratory-assist-system-with-cme-bodyguard-323-pump · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0938-2021

Cite this page

“Alung Hemolung Respiratory Assist System with CME BodyGuard 323 Pump May Have Delivery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63642-alung-hemolung-respiratory-assist-system-with-cme-bodyguard-323-pump. Based on FDA recall #Z-0938-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0938-2021%22&limit=1).

The FDA announced on Dec. 18, 2020, that Alung Technologies Inc. recalled the Hemolung Respiratory Assist System with CME BodyGuard 323 Infusion Pump due to a potential delivery inaccuracy. The agency classified the recall as Class II.

How to tell if you have it

Brand: Alung Technologies
Product: ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA)
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
Quantity: 101 units

The hazard

The CME America BodyGuard 323 Infusion Pump is a component of the Hemolung for EUA and may have a delivery inaccuracy. The pump provides a 30 mL/hr continuous saline flush to the integrated blood pump.

Context

GovInfoNow's records show other recent recalls of similar products include ICU Medical Plum Duo IV Pump Recall (2026-04-29) and ICU Medical Plum Solo IV Pump Recall (2026-04-29). B Braun Medical also recalled Infusomat pumps on 2025-10-29 due to potential medication backflow in IV systems.

How to tell if you have this one

Check if your Hemolung Respiratory Assist System has the CME BodyGuard 323 Infusion Pump with serial numbers listed in the recall notice. The affected units have specific serial numbers starting with A11530 through A16827.

Brand
Alung Technologies
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Verify your device's serial number against the list provided in the recall notice to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

Dec 18, 2020Firm started the recall
Jan 29, 2021FDA classified it Class II
Feb 10, 2021Published in FDA’s Enforcement Report
May 17, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Alung Technologies recalls

Link to this recall

<a href="https://govinfonow.com/recall/63642-alung-hemolung-respiratory-assist-system-with-cme-bodyguard-323-pump">Alung Hemolung Respiratory Assist System with CME BodyGuard 323 Pump May Have Delivery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0938-2021 (December 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0938-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.