BEUDAMED
    FDA Enforcement Class II Terminated

    BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.

    Recall: Z-0233-2018 · Reported December 20, 2017

    Enforcement

    Recall Number
    Z-0233-2018
    Event ID
    77673
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dukal Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2017
    Initiation Date
    June 1, 2017
    Classification Date
    December 12, 2017
    Termination Date
    July 19, 2018
    Address
    2 Fleetwood Ct, N/A, Ronkonkoma, NY, 11779-6907, United States

    Description

    BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.

    Reason

    Intact carton revealed presence of shredded burn sheets

    Code Info

    Lot Numbers: JT13607, JT17507, JT35207, JT09008, JT11308, JT15408, JT18408, JT18708, JT23408, JT24508, JT26408, JT28408, JT31408, JT33508, JT00609, JT04809, JT15209, JT18209, JT19209, JT22409, JT22709, JT23209, JT25309, JT25809, JT27509, JT30109, JT31309, JT32909, JT17510, JT23610, JT24010, JT24810, JT30810, JT35910, JT00811, JT05011, JT07911, JT11511, JT15911, JT17011, JT18211, JT21511, JT26311, JT28411, JT30711, JT00812, JT07312, JT11812, JT13612, JT17712, JT21812, JT25612, JT33012, JT36112, JT36212, JT09113, JT17513, JT24713, JT29813, JT33513, JT01614, JT04614, JT06814

    Distribution

    Worldwide distribution - US Nationwide in the states of: CA, CO, CT, FL, GA, IL, CO, NY, NV, IN, MD, MO, MD OH, TN, TX & WI; and country of Canada

    Quantity

    12095 cases/12 Packs per case/1 sheet