FDAMay 18, 2023device

QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416

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

40588631544734058863154558

Recall history

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

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