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

Recall number

Z-1660-2023

FDA classification

Class II

Brand / firm

Maquet Medical Systems USA

Sold / distributed

Nationwide domestic distribution

Why it was recalled

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.

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

What was recalled

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