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Recall Observatory FDA recall evidence

Device product

CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST

Z-0204-2023

September 26, 2022

Class II

Product summary

Firm
Carefusion 2200 Inc
Event
Event 90958
Status
Ongoing
Classification
Class II
Quantity
1143 units
Official record key
device-enforcement:Z-0204-2023

Official wording

Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

Code information: UDI/DI (01) 10885403018930, 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

    reason.no_named_rule · v1.0.0

    Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.