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
701147047012047170123847701238547012452870124693701273367013021670123853701293957011472 05701214447012384970124474701245297012469470127498701318717012452770113694701202827012144570123850701245257012468970124695701274997012047070124692701202837012166870123852701245267012469170124696701286237012200470127335
- UDI Code04037691670164
- Lot codes
- 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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