PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 23, 2022 Initiated: September 26, 2022 #Z-0219-2023

Product Description

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

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
537 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 LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-61ST. Recalled by Carefusion 2200 Inc. Units affected: 537 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-0219-2023.