Covidien recalls HME devices for tracheostomized patients due to potential sterilization issues with ethylene oxide. Affected items have specific item codes and lot numbers. Consumers should contact the company for details.
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 HME devices for tracheostomized patients that may not have been properly sterilized using ethylene oxide. This could lead to infections or other health risks if the devices are used without proper sterilization.
The devices may not have been properly sterilized using ethylene oxide, which is a critical step for medical devices that require aseptic conditions. This could lead to infections or other health risks if the devices are used without proper sterilization.
Patients who use these HME devices for tracheostomized care, particularly those in hospitals or home care settings. Healthcare providers and patients using the devices for single-use anesthetized or respiratory care patients are most at risk.
Check for the item code 353S13046 on the device packaging. Lot numbers 19F0869FAX, 19F0870FAX, 20G1669FAX, 20G1670FAX, and 20H0377FAX are affected. The product is intended for single use on anesthetized patients.
Look for the item code 353S13046 and affected lot numbers on the packaging.
The company was notified by their supplier in Italy of potential deviations in ethylene oxide sterilization parameters.
The recall does not specify a remedy, so contact Covidien directly for instructions.
Yes, lot numbers 19F0869FAX, 19F0870FAX, 20G1669FAX, 20G1670FAX, and 20H0377FAX are affected.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1869-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1869-2021 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.
