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

    • 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
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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 17, 2021 · Data as of Sep 19, 4:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.