medical Class II Updated 2019-06-19

Maquet Cardiovascular Us Sales, Llc recalls Getinge 86-Series-Medical Washer-Disinfector Part Number:

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serail Numbers: WAA088623 WAA088625 WAA088637 WAA088639 WAA088686 WAA088775 WAA088776 WAA088777 WAA088819 WAA088825 WAA088866 WAA088894 WAA088917 WAA088948 WAA088949 WAA088950 WAA088951 WAA089058 WAA089060 WAA089123 WAA089137 WAA089138 WAA089141 WAA089143 WAA089201 WAA089247 WAA089251 WAA089262 WAA089269 WAA089295 WAA089298 WAA089323 WAA089327 WAA089334 WAA089337 WAA089350 WAA089363 WAA089416 WAA089436 WAA089649
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