The Recall Desk
HighFDA (Devices)·Z-0213-2023·Announced 2022-11-23

CareFusion Genesis Sterilization Containers Fail Validation Testing

CareFusion GENESIS sterilization containers have failed aerosol challenge testing for STERRAD sterilization validation. The recall affects 451 units distributed in the US and 17 other countries.

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 is an FDA Class II recall for sterilization container validation failure that presents a risk of harm—non-sterile surgical instruments could cause infections—but no illnesses or injuries are reported in the source text, placing it at the High severity level per the rubric.

Plain-English summary

CareFusion GENESIS FULL-LENGTH CONTAINERS (REF CD3-5ST) are reusable rigid sterilization containers used in STERRAD sterilization processes to hold surgical instruments during sterilization.

CareFusion has recalled these containers because they have not consistently met the requirements for aerosol challenge testing, which validates that the sterilization process effectively penetrates and sterilizes the container's contents. Failure to meet these requirements indicates the containers may not properly seal or allow adequate sterilant penetration, potentially leaving surgical instruments non-sterile.

Approximately 451 units were 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, the United Kingdom, and the United Arab Emirates. All lots of the product (UDI/DI: 10885403019357) are included in this recall.

Healthcare facilities should immediately stop using the affected containers and contact CareFusion 2200 Inc for guidance on replacement and handling of instruments previously processed in these containers.

The recalled product

Product
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Sterilization Container
Hazard
  • sterilization-failure
  • contamination-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) 10885403019357
  • ALL LOTS

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category