BEUDAMED
    FDA Recall Terminated

    Bard PEG Safety System ''Guidewire'' Reorder Number: 001928

    Recall: Z-1233-03 · Initiated August 4, 2003

    Recall

    Recall Number
    Z-1233-03
    Event Number
    26909
    Firm
    Bard Endoscopic Technologies
    FEI Number
    1000159712
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 4, 2003
    Posted
    September 11, 2003
    Terminated
    April 5, 2006
    Address
    129 Concord Road, Building # 3, Billerica, MA, 01821-7031

    Description

    Bard PEG Safety System ''Guidewire'' Reorder Number: 001928

    Reason

    Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile

    Action

    Bard Endoscopic notified customerson 8/4/03, by Recall Notice sent by registered mail, along with an Effectivity Form that each Bard account will complete and return. Product will be returned to Bard Endoscopic. 5. The BET Recall Coordinator will track effectivity, and phone accounts that have either not returned the Effectivity Form or whose letter had been returned as undeliverable.

    Distribution

    Nationwide AZ, AL, CA, CO, CT, FL, GA, KY, IN, IL, KS, LA, MA, MD, MS, MN, MO, NH, NJ, NY, OH, MI, MO, PA, RI, TN, TX, VA, VT , WA Govt: VA MEDICAL CENTER/CC 800 HOSPITAL DR. COLUMBIA MO 06050

    Quantity

    2 units