CLASS II ONGOING Device recall · Reported 23 Nov 2022 · FDA Enforcement Report
CareFusion V.Mueller Genesis Mid-length Container " 3) 6" recalled
Carefusion 2200 is recalling CareFusion V.Mueller Genesis Mid-length Container " 3) 6" Deep Sterrad Compatible. The recall was initiated on 26 Sep 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0210-2023
- FDA event ID
- 90958
- Recalling firm
- Carefusion 2200, Vernon Hills, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Sep 2022
- FDA classified
- 11 Nov 2022
- Reported
- 23 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 26 Sep 2022 | Recall initiated by company | |
| 11 Nov 2022 | Classified by FDA | +46 days |
| 23 Nov 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST
Where it was distributed
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
Questions about this recall
Is CareFusion V.Mueller Genesis Mid-length Container " 3) 6" Deep Sterrad Compatible recalled?
Yes. Carefusion 2200 recalled CareFusion V.Mueller Genesis Mid-length Container " 3) 6" Deep Sterrad Compatible on 26 Sep 2022. The recall is Class II and its status is Ongoing. Recall number Z-0210-2023.
Why was it recalled?
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Which lots are affected?
UDI/DI (01) 10885403019173, ALL LOTS
Where was it sold?
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 should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Carefusion 2200
All 112Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |