ADRIA recalls specific Herniatome models due to sterilization process not being followed by contract sterilizers. Affected units have model number 5091745 and lot numbers ZV0994 AD0314/2:20 AD0316/20.
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
ADRIA is recalling certain Herniatome surgical tools because contract sterilizers did not follow proper sterilization cycles. This could lead to improper sterilization and potential infection risks if the tools are used without proper cleaning.
The sterilization process was not followed by contract sterilizers, which means the tools might not be properly disinfected. This could lead to infection if the tools are used without adequate cleaning.
Surgical professionals using the specific model number 5091745 Herniatome tools are affected. Those who have the lot numbers ZV0994 AD0314/20 or AD0316/20 are most at risk.
Check for model number 5091745 and lot numbers ZV0994 AD0314/20 or AD0316/20 on the product packaging or label.
Look for model number 5091745 and lot numbers ZV0994 AD0314/20 or AD0316/20 on the product.
The recalling firm was notified by the contract sterilizer that the sterilization cycles were not followed properly.
Check the model number and lot numbers to see if it's affected; if so, contact ADRIA for further instructions.
The recall is due to potential infection risks from improper sterilization, not direct injury risks.
We’ve drafted a message you can send ADRIA to request your refund or repair — edit it as you like.
Subject: Recall Z-0145-2022 — ADRIA ADRIA Hello, I own a ADRIA that is covered by recall Z-0145-2022 from ADRIA. 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.