BEUDAMED
    FDA Enforcement Class II Ongoing

    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: Z-1868-2021 · Reported June 23, 2021

    Enforcement

    Recall Number
    Z-1868-2021
    Event ID
    87925
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 23, 2021
    Initiation Date
    April 29, 2021
    Classification Date
    June 16, 2021
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908, United States

    Description

    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.

    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 Info

    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

    Distribution

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

    Quantity

    192000