GETINGE US SALES LLC recalls Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile…
- Recall date
- November 13, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0677-2020
- FDA classification
- Class II
- Brand / firm
- GETINGE US SALES LLC
- Sold / distributed
- Nationwide Canada
Why it was recalled
Sterile barrier system may be compromised
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
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