Device product
CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST
Z-0218-2023
Product summary
- Event
- Event 90958
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 562 units
- Official record key
device-enforcement:Z-0218-2023
Official wording
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Code information: UDI/DI (01) 10885403019562, 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.