Maquet Medical Systems USA: Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445

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 VKMO 10000-USA 701070441 4058863153889 VKMO 11000-USA 701070445 4058863153889 All lots

UPC codes

4058863153889

Source

Official record: FDA (Device enforcement) ↗

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