BEUDAMED
    FDA Enforcement Class II Terminated

    Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination.

    Recall: Z-0295-2013 · Reported November 21, 2012

    Enforcement

    Recall Number
    Z-0295-2013
    Event ID
    63603
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gulf South Medical Supply Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 21, 2012
    Initiation Date
    June 20, 2012
    Classification Date
    November 15, 2012
    Termination Date
    August 19, 2014
    Address
    4345 Southpoint Blvd, Jacksonville, FL, 32216-8013, United States

    Description

    Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination.

    Reason

    Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.

    Code Info

    Lot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634 Large gloves are Model # 6371, Product # 80635.

    Distribution

    Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.

    Quantity

    275 cases and 17 boxes