Medical device recalls Moderate risk

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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