GENESIS Full-Length Sterilization Containers recalled for failed aerosol testing
CareFusion 2200 Inc recalls GENESIS sterilization containers (model CD3-7ST, all lots) that have not consistently met aerosol challenge testing requirements required for proper sterilization efficacy.
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 medical device recall for a risk-of-harm product (sterilization container with potential for inadequate sterilization) where no illnesses or injuries have been reported. Without reported hospitalizations or injuries, it does not meet the threshold for Severe.
Plain-English summary
CareFusion 2200 Inc is recalling GENESIS Full-Length Sterilization Containers (model CD3-7ST, all lots) because they have not consistently met aerosol challenge testing requirements. These requirements ensure that sterilization containers are designed to allow proper sterilization of enclosed medical devices and instruments.
The affected containers were distributed in the United States and internationally, including 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. The recalled containers are identified by UDI/DI (01) 10885403019432.
Healthcare facilities and medical professionals using these containers should cease use and contact CareFusion 2200 Inc for further guidance on replacement or remediation options.
The recalled product
- Product
- CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD3-7ST
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- inadequate-sterilization
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) 10885403019432
- ALL LOTS
Distribution
Distribution scope not specified by the agency.
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