CareFusion Genesis Sterilization Containers Fail Aerosol Challenge Testing
CareFusion Genesis sterilization containers have failed to consistently meet aerosol challenge testing, potentially leaving surgical instruments inadequately sterilized. 318 units distributed in the US and 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 medical device recall for sterilization containers that failed aerosol challenge testing. No illnesses or injuries have been reported. The hazard is a risk-of-harm product where sterilization failure could lead to contaminated medical instruments, justifying a High severity rating.
Plain-English summary
CareFusion Genesis full-length reusable sterilization containers (model CD3-6ST) are being recalled. These rigid containers, measuring 23 x 12 inches with a 6-inch depth, are used with STERRAD sterilization systems in medical facilities.
The containers have not consistently met the requirements for aerosol challenge testing, which verifies that containers properly sterilize surgical instruments. This failure means some containers may not adequately sterilize instruments.
A total of 318 units were distributed to the United States and 17 other countries, including Australia, Canada, Japan, Mexico, and the United Kingdom. The recall affects all lots of the product.
Medical facilities that have received these containers should review their inventory and contact CareFusion 2200 Inc for further information about this recall.
The recalled product
- Product
- CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- Affected units
- 318
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) 10885403019395
- 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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