FDA recall Z-0677-2020

Product

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

Reason for recall

Sterile barrier system may be compromised

Distribution

Nationwide Canada

Key facts

Status

Ongoing

Initiation date

2019-11-13

Report date

2019-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

WAYNE, NJ, United States

Primary source

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