CareFusion Genesis STERRAD containers fail sterilization testing
Healthcare sterilization containers failed aerosol challenge testing, indicating potential inadequate sterilization of surgical instruments. 493 units affected across US and international markets.
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 risk-of-harm product (sterilization containers critical to surgical safety) where inadequate sterilization poses infection risk, but no injuries have been reported. The failure to meet aerosol challenge testing indicates a quality control issue affecting sterilization effectiveness.
Plain-English summary
CareFusion 2200 Inc. is recalling 493 units of the CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER (REF CD1-4ST), a reusable rigid sterilization container used in healthcare settings to sterilize surgical instruments.
The recalled containers have not consistently met the requirements for aerosol challenge testing, a standard test that verifies sterilization container effectiveness. Failure to meet this test indicates the containers may not adequately sterilize surgical instruments placed inside them.
Healthcare facilities and consumers who have received these containers should stop using them for sterilization purposes. If containers from this recall lot were used, facility personnel should consult with infection control and sterilization experts regarding any instruments that may have been processed in them.
The affected containers are distributed in the United States and internationally, including 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 product
- Product
- CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 493
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) 10885403018978
- 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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