Reported Dec 18, 2019 · Ongoing

Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile…

Getinge US Sales LLC

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: GETINGE US SALES LLC · 45 BARBOUR POND DR · WAYNE, NJ · 07470

Is this the product you have?

  • Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating
  • Sterile REFBEQ-HMOD 30000
Lot codes and dates
  • Lot codes
    • 70114704
    • 70120471
    • 70123847
    • 70123854
    • 70124528
    • 70124693
    • 70127336
    • 70130216
    • 70123853
    • 70129395
    • 7011472 05
    • 70121444
    • 70123849
    • 70124474
    • 70124529
    • 70124694
    • 70127498
    • 70131871
    • 70124527
    • 70113694
    • 70120282
    • 70121445
    • 70123850
    • 70124525
    • 70124689
    • 70124695
    • 70127499
    • 70120470
    • 70124692
    • 70120283
    • 70121668
    • 70123852
    • 70124526
    • 70124691
    • 70124696
    • 70128623
    • 70122004
    • 70127335
  • UDI Code04037691670164
Amount recalled
3633 US

Where it was sold

  • Nationwide

Why it was recalled

Sterile barrier system may be compromised

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:28 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.