Carefusion 2200 Inc Recall 90958
Description: CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST
Carefusion 2200 Inc Recall 90958 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0211-2023 |
Event ID | 90958 |
Event Description | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST |
Product Type | Devices |
Distribution | 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 |
Quantity | 16 units |
Recall Reason | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. |
Device Classification | 20221123 |
Device Code Info | UDI/DI (01) 10885403019203, ALL LOTS |
Center Classification Date | 20221111 |
Recall Initiation Date | 20220926 |
Recalling Firm | Carefusion 2200 Inc |
Initial Notification | Letter |
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