CareFusion sterile containers fail aerosol sterilization test requirement
CareFusion GENESIS sterilization containers did not consistently meet aerosol challenge testing requirements. These containers are used in healthcare facilities to sterilize surgical instruments.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a risk-of-harm medical device. The containers fail aerosol challenge testing requirements, which could compromise proper sterilization of surgical instruments. However, no illnesses, injuries, or deaths have been reported, placing this at Score 3 (High) per the rubric.
Plain-English summary
CareFusion 2200 Inc is recalling the V.Mueller GENESIS MID-LENGTH CONTAINER (REF CD2-8ST), a reusable rigid sterilization container used in healthcare facilities. The containers have not consistently met the requirements for aerosol challenge testing, which validates that the sterilization process effectively eliminates microorganisms from medical instruments.
This recall affects 16 units distributed across the United States and internationally, including Canada, Japan, the United Kingdom, Australia, and other locations. All lots of the product are affected, identified by UDI/DI (01) 10885403019203.
Healthcare facilities using these containers should discontinue use and contact CareFusion 2200 Inc for instructions on replacement or return of the affected units. Proper sterilization validation is critical for patient safety in surgical and medical procedures.
The recalled product
- Product
- CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- sterilization-failure
- equipment-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI (01) 10885403019203
- ALL LOTS
Distribution
Distribution scope not specified by the agency.
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