CareFusion Genesis sterilization containers fail aerosol challenge test requirements
CareFusion Genesis reusable sterilization containers have not consistently passed aerosol challenge testing, which verifies their ability to properly sterilize medical instruments. Approximately 537 units were distributed internationally.
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 Class II recall with no reported illnesses or injuries. The hazard is potential rather than realized—containers may fail to properly sterilize medical instruments, creating a contamination risk, but no actual harm has been reported. This qualifies as High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CareFusion 2200 Inc is recalling the Genesis LARGE reusable rigid sterilization containers (UDI/DI 10885403019593, all lots) because they have not consistently met the requirements for aerosol challenge testing. These containers are used in STERRAD low-temperature hydrogen peroxide gas plasma sterilization systems.
Aerosol challenge testing verifies that containers meet specifications for containing materials during the sterilization process. Containers that fail this test may not properly sterilize medical instruments placed inside them, potentially leaving them contaminated or inadequately sterilized.
Approximately 537 units were distributed to the United States and internationally to Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Saudi Arabia, Singapore, South Africa, Sweden, Thailand, the United Kingdom, and the United Arab Emirates.
Users of these containers should contact CareFusion 2200 Inc regarding this recall and the status of their devices.
The recalled product
- Product
- CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-61ST
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 537
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) 10885403019593
- 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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