medical Class II Updated 2021-06-23

Covidien, LP recalls HME for Tracheostomized Patients, Item Code 353S13046 - Prod

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN Primary Package: 10884521779372 GTIN Secondary Package: 20884521779379 Lot Numbers: 19F0869FAX 19F0870FAX 20G1669FAX 20G1670FAX 20H0377FAX
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