Z-1869-2021Class II

HME for Tracheostomized Patients, Item Code 353S13046 -

Name: Z-1869-2021 HME for Tracheostomized Patients, Item Code 353S13046 -
Creator: Covidien, LP
Published: 2021-04-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-04-29 / Open, Classified / root cause: manufacturing process

FDA source

Covidien, LP began a recall of HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who... on 2021-04-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1869-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-29
Posted: 2021-06-16
Recalling firm: Medtronic, Inc.
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.
Product code: CAH Filter, Bacterial, Breathing-Circuit
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: An Urgent Medical Device Field Safety Notice dated 4/29/21 was sent to customers. Actions you should take: 1. Immediately quarantine and discontinue use of item codes with associated lot numbers listed in Attachment A. 2. If you have distributed the devices listed in Attachment A, please promptly forward the information from this letter to those recipients. Actions being taken by Medtronic: 1. Medtronic is investigating the sterilization records for affected production lots to determine whether sterilization has been achieved despite the deviations. 2. Medtronic will communicate with affected customers regarding the finding of our investigation once complete and will provide direction on what customers should do with the devices quarantined because of this Field Safety Notice. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2. An URGENT MEDICAL DEVICE WITHDRAWAL notification letter dated 7/12/21 was sent to customers. Medtronic has concluded its investigation of potential deviations in the ethylene oxide sterilization processes performed by Steril Milano, the former supplier of our sterilization services for the DAR" airway products. Medtronic analyzed the available sterilization data and conducted validation tests on production lots where data was available. For products where sterilization process data was available and testing could be conducted, we determined that sterilization of those devices was achieved. However, because there was not a consistent controlled process at the sterilization facility, we are issuing a withdrawal of the production lots of the DAR" airway products which are currently under quarantine at your facility. Required Actions: 1. Please return affected product listed on Attachment A as indicated below. All unu
Quantity in commerce: 10890
Distribution: Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution.
Product codes and lots: GTIN Primary Package: 10884521779372 GTIN Secondary Package: 20884521779379 Lot Numbers: 19F0869FAX 19F0870FAX 20G1669FAX 20G1670FAX 20H0377FAX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1869-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1866-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1867-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1868-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-23	2021-06-16
Z-1869-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-23	2021-06-16

Product code CAH

K941381Class IIHygrobac,s Hygroboy and HygrobabyMallinckrodt Medical / cleared 1994-04-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)