HME for Tracheostomized Patients, Item Code 353S13046 - 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.
Check against the official notice below — it lists the full affected range.
Covidien, LP is recalling HME (Heat and Moisture Exchanger) breathing circuit products for tracheostomized patients, Item Code 353S13046, due to potential deviations from validated sterilization parameters during ethylene oxide sterilization performed by their supplier in Italy. The recall affects 10,890 units distributed worldwide, including US distribution in Delaware, Kentucky, New York, Texas, Virginia, Vermont, and Washington, with lot numbers 19F0869FAX, 19F0870FAX, 20G1669FAX, 20G1670FAX, and 20H0377FAX.
These single-use devices are intended for anesthetized and respiratory care patients requiring a breathing circuit. The recall was initiated after the sterilization supplier notified Covidien of potential deviations in the sterilization process. The source document does not specify what remedy consumers should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution. Quantity: 10890 Lot/code info: GTIN Primary Package: 10884521779372 GTIN Secondary Package: 20884521779379 Lot Numbers: 19F0869FAX 19F0870FAX 20G1669FAX 20G1670FAX 20H0377FAX
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.