BEQ-HMOD70000-USA/QUADROX-iD recalled over sterility concerns

Recall date

May 18, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Maquet Medical Systems USA recalls BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859

Recall number

Z-1635-2023

FDA classification

Class II

Brand / firm

Maquet Medical Systems USA

Sold / distributed

Domestic distribution nationwide.

Why it was recalled

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859