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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0211-2023
Event ID90958
Event DescriptionCareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST
Product TypeDevices
DistributionUS and Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Saudi Arabia, Singapore, South Africa, Sweden, Thailand, UK, United Arab Emirates
Quantity16 units
Recall ReasonGenesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Device Classification20221123
Device Code InfoUDI/DI (01) 10885403019203, ALL LOTS
Center Classification Date20221111
Recall Initiation Date20220926
Recalling FirmCarefusion 2200 Inc
Initial Notification Letter
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