FDA-Device2019-12-18Class II

Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000

GETINGE US SALES LLC
Hazard

Sterile barrier system may be compromised

Sold states
Nationwide Canada
Affected count
3633 US
Manufactured in
45 BARBOUR POND DR, N/A, WAYNE, NJ, United States
Products
Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0677-2020

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