BEUDAMED
    FDA Enforcement Class II Terminated

    Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

    Recall: Z-1284-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1284-2020
    Event ID
    84769
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2020
    Initiation Date
    December 18, 2019
    Classification Date
    February 19, 2020
    Termination Date
    August 16, 2022
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908, United States

    Description

    Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

    Reason

    There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

    Code Info

    1) Lot - A9J0014Y Expiration Date - 2024-08-31; 2) Lot - A9J0193Y Expiration Date - 2024-08-31

    Distribution

    US Nationwide distribution.

    Quantity

    139,938 units total