Recall record at a glance
| Official record | Z-0219-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Carefusion 2200 Inc. |
| Report date | Nov 23, 2022 |
| Recall initiation date | Sep 26, 2022 |
| Quantity | 537 units |
| Location | Vernon Hills, IL, United States |
Official 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
Why the product was recalled
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.