BEUDAMED
    FDA Enforcement Class II Terminated

    Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.

    Recall: Z-0758-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0758-2017
    Event ID
    75663
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Halyard Health
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    November 10, 2016
    Classification Date
    December 14, 2016
    Termination Date
    May 4, 2017
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076-2190, United States

    Description

    Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.

    Reason

    Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.

    Code Info

    Product Code: 53130 01 (105313001), Lot numbers: SM52741 and SM52721.

    Distribution

    CA, FL, GA, IA, IN, LA, MA, MN, MT, NM, OR, TX and UT.

    Quantity

    59 cases