Covidien recalls mechanical filters with specific item code due to potential sterilization deviations. Affected units may not be safe for medical use after ethylene oxide processing.
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 mechanical filters with item code 351/5979 that were sterilized using ethylene oxide. This could mean the filters aren't properly sterilized and might not be safe for medical use.
The filters were potentially sterilized improperly using ethylene oxide, which is a chemical sterilization method. If the sterilization process didn't follow validated parameters, the filters might not be sterile and could cause infections or other complications.
Healthcare professionals using these filters for anesthesia or respiratory care patients are most at risk. Patients receiving these filters during medical procedures could be affected.
Check for the item code 351/5979 on the filter packaging. The filters are used for single-patient anesthesia or respiratory care with ISO 15mm or 22mm connectors.
Look for the item code 351/5979 on the filter packaging or label.
The company was notified by a supplier in Italy that the ethylene oxide sterilization process may have deviated from validated parameters.
The recalled filter has the item code 351/5979 and is used for single-patient anesthesia or respiratory care with ISO 15mm or 22mm connectors.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1867-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1867-2021 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.
