Covidien recalls adult-pediatric electrostatic filter HME (item code 352/5877Z) due to potential deviations in ethylene oxide sterilization processes. This product is used for single-use anesthesia and respiratory care. Affected units have specific lot numbers and were sold with certain GTINs.
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Covidien is recalling adult-pediatric electrostatic filters used in anesthesia and respiratory care because their sterilization process may have been compromised. This could lead to improper sterilization, risking infection for patients during medical procedures.
The filters were potentially sterilized using ethylene oxide in a process that deviated from validated parameters. This could mean the filters are not properly sterilized, increasing the risk of infection for patients during medical procedures.
Healthcare professionals using these filters for anesthesia or respiratory care patients are most at risk. Patients receiving the filters during medical procedures could be exposed to potential contamination.
Check for the item code 352/5877Z on the packaging. The product is used for single-use anesthesia and respiratory care. Affected units have specific lot numbers listed in the recall notice.
Look for the item code 352/5877Z and specific lot numbers listed in the recall notice.
The company was notified by their supplier in Italy of potential deviations in ethylene oxide sterilization parameters for these filters.
The filters may not be properly sterilized, which could lead to infection risks for patients during medical procedures.
Check the item code 352/5877Z on the packaging and verify the lot numbers listed in the recall notice.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1868-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1868-2021 from Covidien. 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.
