BEUDAMED
    FDA Recall Terminated

    BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water, Contents: 5cc Silicone Elastomer-Coated Foley Catheter, Waterproof underpad, Synthetic Vinyl Gloves (2), Lubricant, 10cc Syringe (prefilled with sterile water to inflate Foley catheter), Povidone-Iodine swabs (3), CSR Wrap, Plastic Tray. CR.Bard, Inc., Covington,GA 30014, 222.;bardmedical.com.

    Recall: Z-0562-04 · Initiated February 10, 2004

    Recall

    Recall Number
    Z-0562-04
    Event Number
    28310
    Firm
    C.R. Bard, Inc., Urological Division
    FEI Number
    1018233
    Product Code
    KOD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 10, 2004
    Posted
    February 27, 2004
    Terminated
    July 9, 2004
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497

    Description

    BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water, Contents: 5cc Silicone Elastomer-Coated Foley Catheter, Waterproof underpad, Synthetic Vinyl Gloves (2), Lubricant, 10cc Syringe (prefilled with sterile water to inflate Foley catheter), Povidone-Iodine swabs (3), CSR Wrap, Plastic Tray. CR.Bard, Inc., Covington,GA 30014, 222.;bardmedical.com.

    Reason

    The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling.

    Action

    Consignees were notified by certified mail on 02/10/2004.

    Distribution

    AL, CA, CO, FL, GA, IL, IN, KY, MO, MS, NJ, NY, OH, PA, TX and WA.

    Quantity

    1100 units (110 cases)