Covidien recalls Electrostatic Filter Angled (Item Code 350S19006) due to potential sterilization deviations in ethylene oxide processing, affecting single-use medical devices for anesthetized patients.
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 a specific type of electrostatic filter used in medical breathing circuits for patients under anesthesia. The recall is due to concerns that the filters might not have been properly sterilized using ethylene oxide, which could lead to infection risks if used.
The filters may have been improperly sterilized using ethylene oxide, a method that requires precise conditions to ensure safety. If the sterilization process failed, the filters could become contaminated and pose infection risks to patients during medical procedures.
Healthcare providers using this specific electrostatic filter for anesthesia or respiratory care patients are likely affected. Patients receiving care with this filter could be at risk if the filters were not properly sterilized.
Check for the item code 350S19006 on the filter packaging. The filters were sold with lot numbers starting with 20G1304FAX through 20L0412FAX. They are used for single-patient breathing circuits in medical settings.
Identify the item code and lot numbers on the filter packaging to confirm if it is part of the recall.
The company was notified by a sterilization supplier in Italy that the filters may not have been properly sterilized using ethylene oxide, which could lead to infection risks.
The recall record does not specify a remedy, so you should contact the manufacturer directly for guidance.
Yes, the affected lot numbers are 20G1304FAX through 20L0412FAX.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1866-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1866-2021 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.
