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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Covidien, LP: 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.

Agency Publication Date: June 16, 2021
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Affected Products

Product: Electrostatic Filter Angled, Item Code 350S19006 - 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.

GTIN Primary Package: 40884522012981 GTIN Secondary Package: 30884522012984 Lot Numbers: 20G1304FAX 20G1305FAX 20L0026FAX 20L0027FAX 20L0410FAX 20L0411FAX 20L0412FAX

Lot Numbers:
Numbers
Product: Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - 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.

GTIN Primary Package: 20884522033234 GTIN Secondary Package: 10884522033237 Lot Number: 20J0699FAX

Lot Numbers:
Number
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.

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

Lot Numbers:
Numbers
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.

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

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87925
Status: Active
Manufacturer: Covidien, LP
Manufactured In: United States
Units Affected: 4 products (32625; 7200; 192000; 10890)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.