FDAMay 18, 2023device

QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895

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

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

maquet medical systemsmaquetmaquet medical

UPCs

40588630190554058863019185

Recall history

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

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