The Recall Desk
HighFDA (Devices)·Z-0210-2023·Announced 2022-11-23

CareFusion Genesis sterilization containers recalled for failed sterility testing

CareFusion Genesis reusable sterilization containers are recalled after failing aerosol challenge testing requirements. No illnesses or injuries have been reported.

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 a high-risk product—sterilization containers are critical for preventing patient infection. Failure to meet aerosol challenge testing requirements indicates potential sterilization failure. However, no illnesses or injuries have been reported, placing this at the high-risk level per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

CareFusion 2200 Inc is recalling Genesis STERRAD-compatible reusable rigid sterilization containers (mid-length, 19x12 inches, 6 inches deep, model CD2-6ST) because these containers have not consistently met the requirements for aerosol challenge testing.

Healthcare facilities and sterile processing departments that use these containers should stop using them immediately. No illnesses or injuries have been reported. Approximately 265 units were distributed in the United States and internationally. Contact CareFusion 2200 Inc for replacement or return instructions and additional guidance.

The recalled product

Product
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Sterilization Container
Hazard
  • sterilization-failure

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) 10885403019173
  • ALL LOTS

Distribution

Distribution scope not specified by the agency.

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