CareFusion Genesis Sterile Containers Recalled for Failed Sterilization Validation Testing
CareFusion is recalling 308 units of Genesis sterilization containers that failed aerosol challenge testing required to ensure proper sterilization of surgical instruments. The containers were distributed in the US and multiple countries.
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 a medical device that failed sterilization validation testing. No reported illnesses or injuries. Per FDA criteria, this is a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.
Plain-English summary
CareFusion 2200 Inc is recalling 308 units of the GENESIS FULL-LENGTH CONTAINER sterile reusable sterilization containers (Reference CD3-4ST, UDI/DI 10885403019319, all lots). These are reusable medical containers used in healthcare settings to hold surgical instruments during STERRAD sterilization processes.
The containers have not consistently met the requirements for aerosol challenge testing. This testing is required to validate that the containers can properly maintain the sterility of the instruments during sterilization.
The recalled containers were distributed in the United States and internationally, including Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia, Mexico, Norway, the Philippines, Saudi Arabia, Singapore, South Africa, Sweden, Thailand, the United Kingdom, and the United Arab Emirates.
The recall is designated as FDA Class II. Customers with questions about this recall should contact CareFusion.
The recalled product
- Product
- CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- sterilization-failure
- contamination-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) 10885403019319
- ALL LOTS
Distribution
Distribution scope not specified by the agency.
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