CareFusion V — Class II medical device recall Z-0219-2023
Ongoing recall by Carefusion 2200 Inc, reported 2022-11-23. Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol
| Recall number | Z-0219-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 2200 Inc, Vernon Hills, IL, United States |
| Recall initiated | 2022-09-26 |
| Classified | 2022-11-11 |
| Reported by FDA | 2022-11-23 |
| Countries outside the US | AE, AU, BH, CA, DK, GB, HK, IT, JP, MX, MY, NO, PH, SA, SE, SG, TH, ZA |
| Quantity | 537 units |
| UPC / GTIN / UDI-DI | 10885403019593 |
| Model numbers | CD5-61ST |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0219-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.