BEUDAMED
    FDA Enforcement Class III Terminated

    LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.

    Recall: Z-2545-2019 · Reported September 25, 2019

    Enforcement

    Recall Number
    Z-2545-2019
    Event ID
    83704
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 25, 2019
    Initiation Date
    August 19, 2019
    Classification Date
    September 16, 2019
    Termination Date
    July 14, 2020
    Address
    95 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    Description

    LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.

    Reason

    Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month and day were reversed.

    Code Info

    Lot # 201809125 & 201809135

    Distribution

    USA: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, & WV. Distribution US nationwide, Canada, Colombia, Japan, & Malaysia

    Quantity

    4930 units