BEUDAMED
    FDA Recall Terminated

    BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath Preservative Fluid is designed for use with the PrepStain System. SurePath Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial medium for gynecologic specimens.

    Recall: Z-0877-2017 · Initiated February 12, 2016

    Recall

    Recall Number
    Z-0877-2017
    Event Number
    75886
    Firm
    Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    MKQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 12, 2016
    Terminated
    December 27, 2016
    Address
    Sparks, MD, 21152-9212

    Description

    BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath Preservative Fluid is designed for use with the PrepStain System. SurePath Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial medium for gynecologic specimens.

    Reason

    BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.

    Action

    BD Life Sciences sent the initial recall notification on February 12, 2016. The distributors were provided with a written communication via email and customers were provided with a written communication via UPS. For further questions, please call (410) 316-4000.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution including BB(Barbados) and PR (Puerto Rico) and to the states of : AK, AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of: China, Europe, Hong Kong, India, Korea, Mexico, New Zealand, Panama, Singapore, and Taiwan. 480 US customers and 3 US distributors. Product was also shipped to 10 ex-US regions. 15 US government sites received affected product

    Quantity

    16,682.396