Device product

CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST

Z-0213-2023

September 26, 2022

Class II

Product summary

Firm: Carefusion 2200 Inc
Event: Event 90958
Status: Ongoing
Classification: Class II
Quantity: 451 units
Official record key: device-enforcement:Z-0213-2023

Official wording

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

Code information: UDI/DI (01) 10885403019357, 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.