Maquet Medical Systems USA: QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388

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-DI HMO 30000-USA 701070384 4058863153681 HMO 31000-USA 701070388 4058863154299 All lots

UPC codes

4058863153681, 4058863154299

Source

Official record: FDA (Device enforcement) ↗

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