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

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.

Details from the source

Reason for recall: 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. Distribution: Nationwide domestic distribution Quantity: 0 (US) Lot/code info: Model Item No. UDI HMO 10000-USA 701070412 4058863154473 HMO 11000-USA 701070416 4058863154558 All lots

UPC codes

4058863154473, 4058863154558

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.