CareFusion GENESIS Sterilization Containers Fail Aerosol Validation Testing
CareFusion V.Mueller GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. The recall affects 319 units distributed in the US and internationally.
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 of sterilization containers that failed validation testing. This is a risk-of-harm medical device where adequate sterilization function is critical to patient safety, though no illnesses or injuries have been reported.
Plain-English summary
CareFusion 2200 Inc is recalling 319 units of its V.Mueller GENESIS MID-LENGTH sterile reusable containers (19x12 inches, 4 inches deep, STERRAD compatible, REF CD2-4ST). These containers did not consistently meet the requirements for aerosol challenge testing.
Aerosol challenge testing validates that sterilization containers can effectively protect their contents from microbial contamination. Failure to meet these requirements means the containers may not perform as intended for their sterilization function.
The affected units are identified by UDI/DI (01) 10885403019111 in all lots. They have been distributed in the United States and internationally to Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Saudi Arabia, Singapore, South Africa, Sweden, Thailand, the United Kingdom, and the United Arab Emirates.
Healthcare facilities and healthcare professionals who use these containers should stop using the affected units and contact Carefusion 2200 Inc for instructions on replacement or proper disposition.
The recalled product
- Product
- CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD2-4ST
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- sterilization-failure
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) 10885403019111
- ALL LOTS
Distribution
Distribution scope not specified by the agency.
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