Carefusion recalls Genesis STERRAD reusable sterilization containers that failed aerosol challenge testing. These containers may not meet safety standards for sterilization processes.
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Carefusion is recalling Genesis STERRAD reusable sterilization containers that did not consistently pass aerosol challenge testing. This could mean the containers may not properly sterilize medical equipment, risking infection during use.
The containers failed aerosol challenge testing, which checks if they can withstand sterilization processes without leaking harmful particles. If they leak, medical equipment could become contaminated, increasing infection risks during procedures.
Healthcare facilities using Carefusion Genesis STERRAD containers for medical sterilization are likely affected. Staff handling these containers during medical procedures face the highest risk.
Look for the Carefusion Genesis STERRAD containers labeled 28 x 11" (71.1 x 27.9cm) with a 3" (7.6cm) depth. The unique identifier UDI/DI (01) 10885403019562 applies to all lots.
Identify the container's size (28 x 11" or 71.1 x 27.9cm) and depth (3" or 7.6cm) to confirm if it's recalled.
The recall states the containers did not consistently meet aerosol challenge testing requirements, so they may not be safe for sterilization.
Check for the size (28 x 11" or 71.1 x 27.9cm) and depth (3" or 7.6cm) and the unique identifier UDI/DI (01) 10885403019562.
The recall record does not specify a remedy, so contact Carefusion for guidance.
We’ve drafted a message you can send Carefusion to request your refund or repair — edit it as you like.
Subject: Recall Z-0218-2023 — Carefusion Carefusion Hello, I own a Carefusion that is covered by recall Z-0218-2023 from Carefusion. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
