Maquet Medical Systems USA: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-conne

Hazard

Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.

Details from the source

Reason for recall: Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia. Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czechia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Irela Quantity: 10,587 units (US); 94,987 (worldwide) Lot/code info: HLS Set Advanced 5.0, Product Code 70106.9077 UDI-DI 04058863076355 HLS Set Advanced 7.0, Product Code 70106.9078 UDI-DI 04058863080383 All lots/batches affected

UPC codes

04058863076355, 04058863080383

Source

Official record: FDA (Device enforcement) ↗

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