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.
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
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.
The CME BodyGuard 323 Infusion Pump may deliver saline flushes at an inaccurate rate. This could cause the integrated blood pump to function improperly, potentially affecting patient safety.
Patients using the Hemolung Respiratory Assist System with the specific CME BodyGuard 323 Infusion Pump are affected. Those with the listed serial numbers are most at risk.
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.
Verify your device's serial number against the list provided in the recall notice to confirm if it is affected.
The CME BodyGuard 323 Infusion Pump is the specific model being recalled for potential delivery inaccuracy.
Check your pump's serial number against the list of affected serial numbers provided in the recall notice.
The recall notice does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Alung Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-0938-2021 — Alung Technologies Alung Technologies Hello, I own a Alung Technologies that is covered by recall Z-0938-2021 from Alung Technologies. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
