Maquet Cardiovascular Us Sales, Llc recalls Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washe…

Recall date

May 20, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1778-2019

FDA classification

Class II

Brand / firm

Maquet Cardiovascular Us Sales, Llc

Sold / distributed

Worldwide Distribution - US Nationwide GA, IL, IN, MI, NC, OR, PA, VA Foreign: Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine

Why it was recalled

Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.