PlainRecalls
FDA Devices Moderate Class II Ongoing

CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST

Reported: November 23, 2022 Initiated: September 26, 2022 #Z-0206-2023

Product Description

CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST

Reason for Recall

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

Details

Recalling Firm
Carefusion 2200 Inc
Units Affected
1132 units
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
Location
Vernon Hills, IL

Frequently Asked Questions

What product was recalled?
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST. Recalled by Carefusion 2200 Inc. Units affected: 1132 units.
Why was this product recalled?
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 23, 2022. Severity: Moderate. Recall number: Z-0206-2023.