Recall Z-1869-2021— Covidien, LP

Name: FDA recall Z-1869-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-29

Class II · Ongoing

Class II FDA medical device recall by Covidien, LP, initiated 2021-04-29. It names one FDA 510(k) clearance: K941381. 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.. Reason: 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..

Recalling firm: Covidien, LP
Classification: Class II
Status: Ongoing
Initiated: 2021-04-29
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K941381 — HYGROBAC,S HYGROBOY AND HYGROBABYMallinckrodt Medical·cleared 1994-04-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.