BEUDAMED
    FDA Recall 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 · Initiated March 21, 2018

    Recall

    Recall Number
    Z-2943-2018
    Event Number
    80624
    Firm
    Bard Medical Division
    FEI Number
    1018233
    Product Code
    FMH
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    March 21, 2018
    Terminated
    April 2, 2020
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    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.

    Action

    On March 21, 2018 Bard medical Division sent all their customers a recall letter with the following instructions: "Immediately examine your inventory and quarantine product subject to this recall. Please refer to the affected reorder number / lot list in Attachment 1 to help you locate the product. Do not use or further distribute any affected product. "Please complete and return the accompanying Recall & Effectiveness Check Form attached to this letter regardless of whether or not you have any of the affected products. Additional instructions for product return are contained on the form. "If you have further distributed any units from the affected lots, please identify your customers / end users and notify them at once of this product recall by forwarding a copy of this letter. Your notification should include a copy of the this notification and the accompanying enclosures If you have affected product, please contact the Recall Coordinator via phone at 1-800-793-8110 or email [email protected] to obtain a recall authorization number (RCL #).

    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