Z-0203-2023 Class II Ongoing
FDA device recall Z-0203-2023 was initiated by Carefusion 2200 Inc on Sep 26, 2022 and is designated Class II. Reason for recall: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. The recall status is ongoing. Affected quantity: 334 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 23, 2022
- Initiation Date
- Sep 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 334 units
Product Description
CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
Reason for Recall
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
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
Code Information
UDI/DI (01) 10885403018886, ALL LOTS
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0203-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026