The Recall Desk

FDA (Devices) recall action 87925

Covidien, LP recalled 4 products on 2021-06-23

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2021-06-23
Critical
0
Units
242,715

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2021-06-23

    Mechanical respiratory filter recalls due to sterilization process deviation

    Covidien, LP is recalling a mechanical respiratory filter (Item 351/5979) due to potential deviations in ethylene oxide sterilization. The product was distributed worldwide and in multiple U.S. states.

    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.
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2021-06-23

    Electrostatic Filter Angled recalled for sterilization validation deviations

    Covidien LP is recalling Electrostatic Filter Angled devices (Item 350S19006) due to potential deviations in ethylene oxide sterilization parameters. These respiratory airway devices for anesthetized patients may not meet required sterility standards.

    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.
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2021-06-23

    HME for Tracheostomized Patients Recalled Due to Sterilization Process Deviations

    Covidien LP is recalling HME (Heat and Moisture Exchanger) units for tracheostomized patients due to potential deviations from validated ethylene oxide sterilization parameters. The recall affects 10,890 units distributed worldwide and in specific U.S. states.

    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.
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2021-06-23

    Covidien Respiratory Filters Recalled for Sterilization Process Deviations

    Covidien is recalling Adult-Pediatric Electrostatic Filter HMEs due to potential deviations in ethylene oxide sterilization parameters. Approximately 192,000 units were distributed worldwide.

    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.
    Category
    Distribution
    7 states