BEUDAMED
    FDA Enforcement Class II Ongoing

    PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

    Recall: Z-1515-2025 · Reported April 9, 2025

    Enforcement

    Recall Number
    Z-1515-2025
    Event ID
    96461
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ethicon Endo Surgery, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2025
    Initiation Date
    March 7, 2025
    Classification Date
    April 3, 2025
    Address
    475C - Suite 202, Guaynabo, PR, 00969, United States

    Description

    PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

    Reason

    Identified curing issues with the silicone during the needles manufacturing process.

    Code Info

    Product Code: (1) 8706H-15, (2) 8711H-16; GMDN: 13909; UDI-DI: (1) 10705031019430, (2) 10705031019560; Lot number: 104E88, 104E89, 1047TZ, 104BQ0, 104DA2, 104JAR, 104JPJ, 104SES, 104KHD, 104SER;

    Distribution

    Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.

    Quantity

    37,080 units