Class II — Carefusion 2200 Inc
| Recalling firm | CAREFUSION |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. |
| Product | CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST |
| Quantity | 895 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 |
| Initiated | 2022-09-26 |
| Classified | 2022-11-11 |
| Recall number | Z-0216-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Carefusion 2200 Inc (Z-0216-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90958/
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