Covidien, LP: Medical Device Recall in 2021 - (Recall #: Z-1869-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 29, 2021

Date Posted: June 23, 2021

Recall Number: Z-1869-2021

Event ID: 87925

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.

Status: Ongoing

Product Quantity: 10890

Code Information:

GTIN Primary Package: 10884521779372 GTIN Secondary Package: 20884521779379 Lot Numbers: 19F0869FAX 19F0870FAX 20G1669FAX 20G1670FAX 20H0377FAX

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated