CareFusion Sterilization Containers Fail Aerosol Challenge Testing
CareFusion Genesis sterilization containers failed required aerosol challenge testing. The 1,143 affected units may not adequately sterilize surgical instruments.
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: FDA Class II medical device recall for sterilization containers that failed validation testing. No illnesses, injuries, or actual contamination events are reported; the hazard is theoretical, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
CareFusion 2200 Inc is recalling the Genesis QTR-LENGTH CONTAINER (model CD0-4ST), a reusable rigid sterilization container used with STERRAD low-temperature hydrogen peroxide gas plasma sterilization systems. The recall affects 1,143 units distributed to the United States and 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 have not consistently met the requirements for aerosol challenge testing, which validates that sterilization containers adequately maintain sterile conditions for medical instruments during the sterilization process.
Customers who have received these containers should contact CareFusion 2200 Inc for further guidance. The affected units are identified by UDI/DI (01) 10885403018930 and include all lots of this product.
The recalled product
- Product
- CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 1,143
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) 10885403018930
- 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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