BEUDAMED
    FDA Recall Terminated

    18 Gauge thin wall needle as part of a Central Venous Catheter Kit

    Recall: Z-0543-04 · Initiated December 17, 2003

    Recall

    Recall Number
    Z-0543-04
    Event Number
    28167
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 17, 2003
    Posted
    February 24, 2004
    Terminated
    July 27, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    18 Gauge thin wall needle as part of a Central Venous Catheter Kit

    Reason

    18 gauge needles in Central Venous Catheter kits may be partially occluded.

    Action

    Consignees were notified by FedEx letter on 12/17/2003.

    Distribution

    Nationwide including VA facilities in ID and NC. Foreign distribution to Australia, Austria, Belgium, Brazil, Canada, Chile, Columbia, Dominican Republic, Egypt, Greece, Ireland, Italy, Japan, Malaysia, Portugal, Slovenia, Spain, Switzerland, Turkey, UK, United Arab Emirates.

    Quantity

    93564