Copan recalls FLOQSwabs and STERILE.EO swabs due to sterility assurance failures from a contract sterilizer. These swabs may not be sterile, risking infections during clinical sampling.
A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.
Copan is recalling FLOQSwabs and STERILE.EO swabs used for clinical samples because the sterilization process was compromised by fraud at a contract sterilizer. This means the swabs might not be sterile, potentially causing infections if used in medical procedures.
The swabs were sterilized by a contract facility (Steril Milano) that engaged in intentional fraud and data manipulation, which means the sterility assurance level of 10-6 could not be guaranteed. This risk of contamination could lead to infections during medical procedures.
Healthcare professionals and labs using the recalled swabs for clinical sampling are most at risk. Patients using these swabs could face infection if the swabs are not properly sterile.
Check for product reference numbers like REF:501CS01, REF:20226, or REF:503CS01 on the packaging. The swabs are sold with CE0123 certification for clinical use.
Look for reference numbers such as REF:501CS01, REF:20226, or REF:503CS01 on the packaging to confirm if your swabs are recalled.
The swabs were sterilized by a contract facility (Steril Milano) that engaged in intentional fraud and data manipulation, which means the sterility assurance level of 10-6 could not be guaranteed.
Check the product reference numbers on the packaging to see if they are recalled. If they are, you should stop using them and contact Copan for further instructions.
Yes, the swabs may not be sterile, which could lead to infections during medical procedures if used improperly.
We’ve drafted a message you can send Copan to request your refund or repair — edit it as you like.
Subject: Recall Z-2440-2021 — Copan Copan Hello, I own a Copan that is covered by recall Z-2440-2021 from Copan. 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.
