BEUDAMED
    FDA Enforcement Class II Ongoing

    Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)

    Recall: Z-1389-2023 · Reported April 19, 2023

    Enforcement

    Recall Number
    Z-1389-2023
    Event ID
    91873
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2023
    Initiation Date
    March 1, 2023
    Classification Date
    April 12, 2023
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)

    Reason

    Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.

    Code Info

    GTIN: 20884521054339, 20884521054438; Lot: D2H0095ZY, D2H0096ZY

    Distribution

    Worldwide Distribution: US (nationwide) to States of: AR, CA, FL, GA, LA, MA, NC, NY, OH, WA; and countries of: Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand.

    Quantity

    960 units