BEUDAMED
    FDA Enforcement Class II Terminated

    Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.

    Recall: Z-2943-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2943-2018
    Event ID
    80624
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Medical Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2018
    Initiation Date
    March 21, 2018
    Classification Date
    August 25, 2018
    Termination Date
    April 2, 2020
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    Description

    Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.

    Reason

    Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iodine assay level requirements to support 36 month expiration dating.

    Code Info

    Catalog #842802 Lot #'s: NGZF4111, NGZF0382, NGZE0787, NGZD3819, NGZI1126, NGAP2619, NGAT0331, NGAT4059, NGAW1807, and NGBS2822

    Distribution

    AR, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, SC, TN, TX, UT, and WA,

    Quantity

    131,950