Getinge recalls pediatric oxygenators with potential sterile barrier compromise. Affected units have specific lot codes; stop use immediately if you own one.
Sterile barrier system may be compromised
Getinge is recalling pediatric oxygenators that may have a compromised sterile barrier. This could lead to infections or contamination during medical use. Affected units have specific lot codes listed in the recall.
The sterile barrier system may be compromised, potentially allowing contamination or infection during medical procedures. This is a critical risk for infants receiving oxygen therapy.
Medical facilities using the Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating are most at risk. Parents or caregivers of infants requiring this oxygenator should check if their unit is affected.
Check for lot codes: 70114704, 70120471, 70123847, 70123854, 70124528, 70124693, 70127336, 70130216, and others listed in the recall. The UDI code is 04037691670164.
Immediately stop using the affected oxygenator as it may be contaminated.
The Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile.
Check the lot codes listed in the recall: 70114704, 70120471, 70123847, 70123854, 70124528, 70124693, 70127336, 70130216, and others.
The recall does not mention a remedy or replacement option.
We’ve drafted a message you can send Getinge to request your refund or repair — edit it as you like.
Subject: Recall Z-0677-2020 — Getinge Getinge Hello, I own a Getinge that is covered by recall Z-0677-2020 from Getinge. 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.
