Genesis STERRAD Sterilization Containers Fail Aerosol Challenge Testing
CareFusion's Genesis sterilization containers failed to meet FDA aerosol challenge testing requirements, affecting 895 units distributed in the US and internationally. Proper container function is essential to ensure medical instruments are adequately sterilized.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA Class II medical device recall involves a functional defect affecting sterilization efficacy. The failure to meet aerosol challenge testing requirements represents a risk-of-harm situation for patient safety (potential use of inadequately sterilized instruments), though no illnesses or injuries have been reported.
Plain-English summary
CareFusion 2200 Inc has issued a recall for the Genesis SMALL sterilization container (model CD4-3ST) because the containers have not consistently met FDA requirements for aerosol challenge testing. This testing is essential to verify that medical instruments are properly sterilized within the containers.
The recall affects 895 units distributed across the United States and 17 additional countries: 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 affected containers are identified by UDI/DI (01) 10885403019500 and encompass all lot numbers.
Healthcare facilities that have received these sterilization containers should contact CareFusion 2200 Inc directly for specific recall instructions and guidance regarding any instruments previously sterilized using these containers.
The recalled product
- Product
- CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 895
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) 10885403019500
- ALL LOTS
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 17 recalled by Carefusion 2200 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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