BEUDAMED
    FDA Enforcement Class II Terminated

    Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.

    Recall: Z-0564-2013 · Reported December 26, 2012

    Enforcement

    Recall Number
    Z-0564-2013
    Event ID
    62394
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 26, 2012
    Initiation Date
    October 2, 2012
    Classification Date
    December 19, 2012
    Termination Date
    May 3, 2016
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.

    Reason

    BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.

    Code Info

    Device Listing Number - R060456 REF Lot # 305217 2076404 305217 2055156 305217 2020057 305217 2020056 305219 1346419

    Distribution

    (USA) nationwide

    Quantity

    2,786,000 units