BEUDAMED
    FDA Enforcement Class II Terminated

    DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND PRINEO System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound durinQ application of the liquid adhesive

    Recall: Z-1147-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1147-2018
    Event ID
    79355
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 28, 2018
    Initiation Date
    November 27, 2017
    Classification Date
    March 20, 2018
    Termination Date
    April 30, 2019
    Address
    Us Highway 22 West, N/A, Somerville, NJ, 08876, United States

    Description

    DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND PRINEO System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound durinQ application of the liquid adhesive

    Reason

    Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.

    Code Info

    LEJ230 LEJ246 LEJ259 LEJ368 LGP375 LGP605 LGP606 LGP675 LGP814 LGR689 LGR710 LGR756 LHH468 LHH469 LHH560 LHH608 LHH686 LHH784 LHP498 LHP599 LHP602 LHP868

    Distribution

    US Nationwide Distribution

    Quantity

    20,090 eaches (10,545 units)