CareFusion Genesis Mini Sterilization Containers fail aerosol testing
CareFusion Genesis Mini Containers used for surgical instrument sterilization have not consistently met aerosol challenge testing requirements, which may affect their ability to protect instruments during sterilization.
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: This is an FDA Class II medical device recall involving failure to meet aerosol challenge testing requirements, which could compromise surgical instrument sterilization. No illnesses or injuries have been reported. Per the rubric, this is a risk-of-harm product without reported injury, scored as High (3).
Plain-English summary
CareFusion's Genesis Mini Containers, used in STERRAD sterilization processes for medical instruments, have not consistently met the requirements for aerosol challenge testing. This testing is intended to verify that containers adequately protect surgical instruments during sterilization.
The affected product is the Genesis Mini Container measuring 10-1/2 by 7-1/2 inches, 3 inches deep (reference number CD0-3ST). All manufacturing lots are included in this recall. A total of 334 units have been distributed to healthcare facilities in the United States and internationally.
Further information about this recall is available from CareFusion 2200 Inc and the FDA.
The recalled product
- Product
- 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
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- inadequate-sterilization
- aerosol-penetration
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) 10885403018886
- ALL LOTS
Distribution
Distribution scope not specified by the agency.
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