CareFusion Genesis Sterile Containers Fail Sterilization Testing Requirements
Reusable sterilization containers manufactured by Carefusion have not consistently met aerosol challenge testing requirements. 483 units distributed in the US and internationally are being recalled.
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 a risk-of-harm medical device where failure to meet sterilization testing requirements could lead to inadequate sterilization and infection risk. Although no illnesses or injuries have been reported, the potential for serious harm is significant in a surgical/medical setting. Per the rubric, this qualifies as a high-risk product without reported injury.
Plain-English summary
The U.S. Food and Drug Administration is recalling Genesis STERRAD Reusable Rigid Sterilization Containers manufactured by Carefusion 2200 Inc. The containers have not consistently met the requirements for aerosol challenge testing, which validates the effectiveness of the sterilization process.
The recalled containers (UDI/DI 10885403019531, all lots) were distributed in the United States and internationally, including to Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Saudi Arabia, Singapore, South Africa, Sweden, Thailand, United Kingdom, and United Arab Emirates. A total of 483 units have been identified.
Failure to meet sterilization testing requirements could potentially compromise the containers' ability to ensure proper sterilization of medical instruments and equipment. Healthcare facilities and users should contact Carefusion 2200 Inc for instructions on returning the affected containers or obtaining replacements.
The recalled product
- Product
- CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- sterilization-failure
- infection-risk
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) 10885403019531
- ALL LOTS
Distribution
Distribution scope not specified by the agency.
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