The Recall Desk
HighFDA (Devices)·Z-0209-2023·Announced 2022-11-23

CareFusion sterilization containers fail aerosol challenge testing

CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. The FDA is recalling 510 units to prevent potential sterilization failures.

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: FDA Class II medical device with failed sterilization validation testing represents a risk-of-harm scenario; improper sterilization poses serious infection risk. However, no illnesses or injuries have been reported, keeping this at High rather than Severe per the rubric.

Plain-English summary

CareFusion 2200 Inc is recalling the V.Mueller GENESIS MID-LENGTH CONTAINER (REF CD2-5ST), a reusable rigid sterilization container used for sterilizing surgical instruments. The containers have not consistently met the requirements for aerosol challenge testing, which verifies that sterilization processes are effective.

Sterilization containers that fail aerosol challenge testing may not properly sterilize instruments placed within them. This creates a risk of non-sterile instruments being used in medical procedures, potentially leading to healthcare-associated infections.

The recall affects 510 units with UDI/DI (01) 10885403019142 across all lots. Distribution includes the United States and 17 international locations: 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.

Healthcare facilities using these containers should discontinue use and contact CareFusion 2200 Inc for replacement or return instructions. No illnesses or injuries have been reported as of this recall.

The recalled product

Product
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instrument Sterilization
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) 10885403019142
  • ALL LOTS

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category