BEUDAMED
    FDA Recall Terminated

    Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE, REF 000256, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.

    Recall: Z-2017-2009 · Initiated January 20, 2009

    Recall

    Recall Number
    Z-2017-2009
    Event Number
    52862
    Firm
    C R Bard Inc
    FEI Number
    3006260740
    Product Code
    KGC
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    January 20, 2009
    Posted
    September 17, 2009
    Terminated
    December 9, 2009
    Address
    605 N 5600 W, Salt Lake City, UT, 84116-3738

    Description

    Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE, REF 000256, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.

    Reason

    Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.

    Action

    Customers were notified by letter and instructed to not use or further distribute any of the affected lot numbers. Customers were further instructed to return the recalled products to Bard Access Systems (BAS) through a return goods authorization number. Questions and requests for assistance should be directed to BAS Customer Service at 800-290-1689.

    Distribution

    Worldwide Distribution -- US, Canada, Austria, Australia, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, Sweden and Switzerland, Japan, and Latin America.

    Quantity

    13, 337 total of all products