Device recall: CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF…
Class II FDA enforcement event 90958. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Carefusion 2200 Inc started this device recall on 26 Sep 2022. The firm address in the FDA record is in Vernon Hills, IL. FDA put the recall in Class II. FDA event 90958 has 17 product records. The first FDA enforcement report date is 23 Nov 2022. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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
Recalling firm
Carefusion 2200 Inc, Vernon Hills, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
17 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0203-2023 | 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 | 334 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0204-2023 | CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST | 1143 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0205-2023 | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST | 493 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0206-2023 | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST | 1132 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0207-2023 | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD1-6ST | 259 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0208-2023 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD2-4ST | 319 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0209-2023 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST | 510 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0210-2023 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST | 265 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0211-2023 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST | 16 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0212-2023 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST | 308 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0213-2023 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST | 451 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0214-2023 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST | 318 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0215-2023 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD3-7ST | 50 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0216-2023 | CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST | 895 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0217-2023 | CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST | 483 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0218-2023 | CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST | 562 units | Class II | Ongoing | 23 Nov 2022 |
| Z-0219-2023 | CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-61ST | 537 units | Class II | Ongoing | 23 Nov 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 17Median of the firm: 2
- Events of the firm on the register
- 16
Other events of the firm
Official channels
- FDA enforcement report Z-0203-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 90958. https://recallregister.com/fda/ii/90958/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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
- What quantity of product is in FDA event 90958?
- The event has 17 product records. The first record gives this quantity:
334 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.