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FDAMay 18, 2023device

QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

What to do

FDA enforcement status: Ongoing

Brands named

maquet medical systemsmaquetmaquet medical

UPCs

405886301914740588630173414058863017372

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829 — Recall Details · AllClear