Z-0209-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 23, 2022
- Initiation Date
- September 26, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 510 units
Product Description
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST
Reason for Recall
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
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
Code Information
UDI/DI (01) 10885403019142, ALL LOTS