Mechanical respiratory filter recalls due to sterilization process deviation
Covidien, LP is recalling a mechanical respiratory filter (Item 351/5979) due to potential deviations in ethylene oxide sterilization. The product was distributed worldwide and in multiple U.S. states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a potential sterilization process deviation affecting a respiratory filter used on vulnerable anesthetized and respiratory care patients. Although no illnesses or injuries have been reported, the product represents a risk of harm if inadequately sterilized, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Covidien, LP is recalling Mechanical Filters with Connector Small, Tethered Cap (Item Code 351/5979, Lot Number 20J0699FAX). The product is indicated for single use on anesthetized patients and respiratory care patients who require breathing circuits with ISO standard 15mm or 22mm connectors.
The recall was initiated because the company's supplier of sterilization services for airway products in Italy notified Covidien, LP of potential deviations from validated parameters for ethylene oxide sterilization. Inadequate sterilization could compromise the safety and effectiveness of the product.
The affected product was distributed worldwide and within the United States in Delaware, Kentucky, New York, Texas, Virginia, Vermont, and Washington.
Patients and healthcare providers who have received or are using this product should contact their medical supply provider or Covidien, LP immediately for instructions on how to proceed.
The recalled product
- Product
- Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
- Manufacturer
- Covidien, LP
- Hazard
- sterilization-failure
- contamination-risk
Distribution
Distributed nationwide across the United States.
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