Reported Feb 10, 2021 · Terminated
ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage:…
Alung Technologies Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alung Technologies Inc · 2500 Jane St Ste 1 · Pittsburgh, PA · 15203-2216
Is this the product you have?
- ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323
- Infusion Pump(EUA) - Product Usagean off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing
- Lot codes and dates
- Serial Numbers
101 of 101 codes
A11530A11531A11532A11533A11534A11535A11536A11537A11538A11539A11541A11543A11544A11545A11546A11548A11552A11553A11554A11555A11556A11557A11561A11562A11563A11565A11566A11567A11568A11569A11570A11571A11572A11573A11575A11576A11577A11578A11579A11580A11581A11582A11583A11584A11585A11586A11587A11590A11591A11592A16164A16794A16795A16796A16797A16798A16799A16800A16801A16802
- Serial Numbers
- Amount recalled
- 101 units
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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