FDA-Device2020-03-18Class II
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
Maquet Cardiovascular Us Sales, Llc
Hazard
Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water
Sold states
Nationwide Foreign: Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Iran, Ireland, Israel, Italy, Japan, Kenya, Lithuania, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom
Affected count
146 US
Manufactured in
45 Barbour Pond Dr, Wayne, NJ, United States
Products
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1475-2020Don't want to check this manually?
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