CareFusion Genesis Sterilization Containers Fail Required Aerosol Challenge Testing
CareFusion Genesis sterilization containers failed to meet aerosol challenge testing requirements and may not properly sterilize medical 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: This is an FDA Class II medical device recall for sterilization containers that failed aerosol challenge testing. Such containers represent a risk-of-harm product, as inadequate sterilization of medical instruments could lead to infections during procedures. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury are classified as High.
Plain-English summary
CareFusion Genesis half-length sterilization containers (Reference CD1-6ST) have been recalled because they do not consistently meet aerosol challenge testing requirements.
These containers are designed for use with STERRAD sterilization systems to sterilize reusable medical instruments. Aerosol challenge testing is a validation standard used to verify that sterilization containers can properly maintain a sterile environment. When containers fail this testing, their ability to effectively sterilize contents may be compromised.
The recall affects 259 units with UDI-DI (01) 10885403019050 across all manufacturing lots. The containers have been distributed to healthcare facilities in the United States and internationally, including Canada, Australia, Japan, and numerous other countries.
Healthcare facilities that have received these containers should discontinue their use and contact CareFusion 2200 Inc to arrange for replacement containers.
The recalled product
- Product
- CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD1-6ST
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 259
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) 10885403019050
- 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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