BEUDAMED
    FDA Enforcement Class III Terminated

    Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100

    Recall: Z-2061-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2061-2019
    Event ID
    81779
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medela Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2019
    Initiation Date
    December 5, 2018
    Classification Date
    July 23, 2019
    Termination Date
    August 25, 2020
    Address
    1101 Corporate Dr, N/A, McHenry, IL, 60050-7006, United States

    Description

    Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100

    Reason

    The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.

    Code Info

    Model Number: 90003S-100; Lot codes: 441113, 441825, 441965, 442099, 442188, 442494, 442612, 443265, 443557, 444054, 444317, 445260, 445310, 445470, 445678, 446402, 446518, 446916, 447447, 447470, 447789.

    Distribution

    Nationwide distribution in IL, MO, NE, OH, RI, TN, TX, VA. International distribution in Canada Internal Medela and sales reps located in CA, CO, IL, LA, NC, NJ, NV, PA, SC, TN, TX Domestic Hospitals located in AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI

    Quantity

    665,600 lids (6,656 cases)