CareFusion GENESIS Sterilization Containers Recalled for Inadequate Aerosol Challenge Testing
Carefusion 2200 Inc is recalling 562 Genesis STERRAD reusable sterilization containers due to failure to consistently meet aerosol challenge testing requirements, used to sterilize surgical instruments in healthcare facilities.
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 with no reported illnesses or injuries. The hazard—failure to meet sterilization validation requirements—represents a risk of harm in a critical-use product (sterilization containers for surgical instruments) where failure could result in infection, but no actual injuries have been reported, warranting High severity per the rubric.
Plain-English summary
Carefusion 2200 Inc has recalled 562 units of CareFusion V.Mueller GENESIS LARGE sterilization containers (reference CD5-3ST, UDI/DI 01 10885403019562, all lots) due to inadequate performance on aerosol challenge testing. These reusable rigid sterilization containers are used in healthcare facilities to sterilize surgical instruments and medical devices using the STERRAD sterilization process.
The containers have not consistently met the requirements for aerosol challenge testing, a critical validation test that confirms sterilization containers maintain proper sterile conditions. Failure to meet these requirements could result in inadequately sterilized instruments being returned to clinical use, creating a potential infection risk.
The affected containers are distributed in the United States and internationally, including Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia, Mexico, Norway, the Philippines, Saudi Arabia, Singapore, South Africa, Sweden, Thailand, the United Kingdom, and the United Arab Emirates.
Healthcare facilities currently using these containers should discontinue use and contact Carefusion 2200 Inc for instructions regarding replacement or appropriate disposition of the recalled units.
The recalled product
- Product
- CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 562
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) 10885403019562
- 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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