Maquet Medical Systems USA: QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895

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: 1,784 (US) Lot/code info: Model Item no. UDI-DI BEQ-HMO 50000-USA 701067905 4058863019079 HMO 50000-USA 701067891 4058863019055 HMO 51000-USA 701067895 4058863019185 All lots

UPC codes

4058863019079, 4058863019055, 4058863019185

Source

Official record: FDA (Device enforcement) ↗

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