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Recall Observatory FDA recall evidence

Device 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.

Z-1869-2021

April 29, 2021

Class II

Product summary

Firm
Covidien, LP
Event
Event 87925
Status
Ongoing
Classification
Class II
Quantity
10890
Official record key
device-enforcement:Z-1869-2021

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.