Skip to content
Recall Observatory FDA recall evidence

Device product

CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-61ST

Z-0219-2023

September 26, 2022

Class II

Product summary

Firm
Carefusion 2200 Inc
Event
Event 90958
Status
Ongoing
Classification
Class II
Quantity
537 units
Official record key
device-enforcement:Z-0219-2023

Official wording

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

Code information: UDI/DI (01) 10885403019593, 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.