BEUDAMED
    FDA Enforcement Class II Ongoing

    Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45CM P12 X36 (SG-5637), CHROMIC GUT 5-0 45CM P-13 X12 (SG-5687G), CHROMIC GUT 5-0 75CM CV23 (UG-202), CHROMIC GUT 4-0 75CM CV23 X36 (UG-203)

    Recall: Z-1388-2023 · Reported April 19, 2023

    Enforcement

    Recall Number
    Z-1388-2023
    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

    Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45CM P12 X36 (SG-5637), CHROMIC GUT 5-0 45CM P-13 X12 (SG-5687G), CHROMIC GUT 5-0 75CM CV23 (UG-202), CHROMIC GUT 4-0 75CM CV23 X36 (UG-203)

    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: 20884521054001, 20884521054056, 20884521054889, 20884521054896, 20884521054896, 20884521054902, 20884521054902, 10884521054905, 20884521054940, 20884521055688, 20884521055770, 20884521056135, 10884521056145, 20884521056142, 20884521056142, 20884521056142; Lot: D2H1593ZY D2H1022ZY D2F1106ZY D2H1607ZY D2H1609ZY D2H0819ZY D2H2053ZY D2H2053ZY D2H2055ZY D2H1435FZY D2H0829FZY D2H0830FZY D2H0381ZY D2H1523ZY D2H1584ZY D2H1584ZY D2H1587ZY D2H1589ZY

    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

    36204 units