CareFusion GENESIS Sterilization Containers Fail Aerosol Challenge Testing
CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. Approximately 1,132 units distributed to healthcare facilities in the U.S. and internationally are affected.
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 is a risk-of-harm medical device where sterilization efficacy cannot be assured, but no illnesses or injuries have been reported. As an FDA Class II device without reported hospitalizations, it does not qualify for Severe classification.
Plain-English summary
CareFusion GENESIS HALF-LENGTH CONTAINER sterilization containers have been recalled due to failure to consistently meet aerosol challenge testing requirements.
Approximately 1,132 units with model reference CD1-5ST (UDI/DI 10885403019012) across all lots have been distributed to healthcare facilities 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.
Healthcare facilities and medical professionals using these sterilization containers should contact CareFusion for guidance on replacement or corrective actions.
The recalled product
- Product
- CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 1,132
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) 10885403019012
- 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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