Device product
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST
Z-0209-2023
Product summary
- Event
- Event 90958
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 510 units
- Official record key
device-enforcement:Z-0209-2023
Official wording
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Code information: UDI/DI (01) 10885403019142, ALL LOTS
Distribution pattern: 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
Derived failure modes
-
Unknown
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.