The Recall Desk
HighFDA (Devices)·Z-0938-2021·Announced 2021-02-10

Alung Technologies Recalls Hemolung Respiratory Assist System Infusion Pumps

Alung Technologies is recalling 101 Hemolung Respiratory Assist System units due to potential delivery inaccuracy in the CME BodyGuard 323 infusion pump component.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a 'High' severity score when no hospitalizations or serious injuries are explicitly reported in the source text.

Plain-English summary

Alung Technologies Inc is recalling 101 units of the Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump. The recall is due to a potential delivery inaccuracy in the infusion pump, which is a component used to provide a continuous saline flush to the integrated blood pump bearing.

The affected units were distributed nationwide in the United States. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

Healthcare providers and facilities should stop using the affected infusion pumps and contact Alung Technologies for further instructions on the recall process.

The recalled product

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.
Manufacturer
Alung Technologies Inc
Category
Medical Device — Respiratory Assist System
Hazard
Affected units
101

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · delivery inaccuracy

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