Maquet Medical Systems USA: QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829

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 70000-USA 701067820 4058863019147 HMO 71000-USA 701067823 4058863017341 BEQ-HMO 71000-USA 701067829 4058863017372 All lots

UPC codes

4058863019147, 4058863017341, 4058863017372

Source

Official record: FDA (Device enforcement) ↗

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