Covidien, LP: Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - 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.

Recall number

Z-1868-2021

Recalling firm

Covidien, LP

Product

Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - 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.

Status

Open, Classified

Initiated

2021-04-29

Posted

2021-06-16

Terminated

not on file

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.

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

192000

Distribution

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

Lot, serial or model codes

GTIN Primary Package: 10884521077409 GTIN Secondary Package: 20884521077406  Lot Numbers: 20C1164FAX 20C1165FAX 20C1166FAX 20C1235FAX 20C1236FAX 20D1187FAX 20D1188FAX 20D1189FAX 20D1190FAX 20D1191FAX 20D1429FAX 20D1430FAX 20D1432FAX 20D1433FAX 20D1523FAX 20D1524FAX 20D1525FAX 20D1526FAX 20D1527FAX 20D1528FAX 20E0158FAX 20E0159FAX 20E0160FAX 20E0161FAX 20E0162FAX 20E0163FAX 20E0164FAX 20E0165FAX 20E0390FAX 20E0391FAX 20E0392FAX 20E0393FAX 20E0871FAX 20E0873FAX 20E0874FAX 20E0875FAX 20E0935FAX 20E0936FAX 20E0997FAX 20E0998FAX

510(k) numbers

K941535

PMA numbers

not on file

Product code

CAH

Firm FEI

1219930

Firm city

North Haven

Firm state

CT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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