BEUDAMED
    FDA Enforcement Class II Ongoing

    MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H

    Recall: Z-2148-2024 · Reported June 26, 2024

    Enforcement

    Recall Number
    Z-2148-2024
    Event ID
    94643
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 26, 2024
    Initiation Date
    May 10, 2024
    Classification Date
    June 14, 2024
    Address
    1000 Route 202, N/A, Raritan, NJ, 08869-1425, United States

    Description

    MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H

    Reason

    Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

    Code Info

    GTIN: GTIN 10705031058729 10705031058897 10705031059047 10705031059092 10705031059122 30705031059133 10705031112674 10705031059146 10705031059153 10705031059245 10705031059894 10705031059917 10705031059962 PRODUCT CODE PRODUCT LOTS Y315H UAMQCX Y345H UBMCAJ Y359H UBMHQS Y398H UAMLMU UAMPJB UAMMXQ UBMJPB UBMQQR Y416H UAMLQM UAMLKM UAMRMZ Y417H UCMEDU Y426H UAMKCL UAMKHE UAMPQS UBMJTE Y427H UAMLXX UAMMJR UAMPSC Y935H UBMCAA UBMDKJ UBMDKC UBMHDD Y936H UBMJQM Y945H UAMKCD

    Distribution

    Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.

    Quantity

    306000 units