The Recall Desk
HighFDA (Devices)·Z-0216-2023·Announced 2022-11-23

Genesis STERRAD Sterilization Containers Fail Aerosol Challenge Testing

CareFusion's Genesis sterilization containers failed to meet FDA aerosol challenge testing requirements, affecting 895 units distributed in the US and internationally. Proper container function is essential to ensure medical instruments are adequately sterilized.

What this means for you

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 FDA Class II medical device recall involves a functional defect affecting sterilization efficacy. The failure to meet aerosol challenge testing requirements represents a risk-of-harm situation for patient safety (potential use of inadequately sterilized instruments), though no illnesses or injuries have been reported.

Plain-English summary

CareFusion 2200 Inc has issued a recall for the Genesis SMALL sterilization container (model CD4-3ST) because the containers have not consistently met FDA requirements for aerosol challenge testing. This testing is essential to verify that medical instruments are properly sterilized within the containers.

The recall affects 895 units distributed across the United States and 17 additional countries: 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 affected containers are identified by UDI/DI (01) 10885403019500 and encompass all lot numbers.

Healthcare facilities that have received these sterilization containers should contact CareFusion 2200 Inc directly for specific recall instructions and guidance regarding any instruments previously sterilized using these containers.

The recalled product

Product
CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Sterilization Container
Hazard
  • sterilization-failure
  • infection-risk

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) 10885403019500
  • ALL LOTS

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category