FDA-Device2022-11-23Class II
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
Carefusion 2200 Inc
Hazard
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Sold states
US and Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Saudi Arabia, Singapore, South Africa, Sweden, Thailand, UK, United Arab Emirates
Affected count
318 units
Manufactured in
75 N Fairway Dr, N/A, Vernon Hills, IL, United States
Products
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0214-2023Don't want to check this manually?
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