BEUDAMED
    FDA Recall Terminated

    THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit

    Recall: Z-2693-2011 · Initiated May 19, 2011

    Recall

    Recall Number
    Z-2693-2011
    Event Number
    58975
    Firm
    Medical Components, Inc dba MedComp
    FEI Number
    2518902
    Product Code
    MSD
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    May 19, 2011
    Posted
    June 28, 2011
    Terminated
    October 24, 2016
    Address
    1499 Delp Dr, Harleysville, PA, 19438

    Description

    THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit

    Reason

    Product was packaged with the incorrect valved peelable introducer. The catheter sized is 15.5F and the introducer packaged in the kit is a 15F. The kit should contain a 16F introducer.

    Action

    Medcomp sent a "PRODUCT ALERT" letter dated May 19, 2011 to all affected customers. The letter described the product, problem, and actions to be taken. The letter is requesting the return of all affected product. Customers are instructed to contact their customer service representative for an RGA (returned good authorization) number. If you have any questions or concerns contact Medcomp at 215-256-4201 ext. 2225.

    Distribution

    Worldwide Distribution -- USA (nationwide) including states of AZ, CA, CO and RI and countries of Australia, Brazil, and Netherlands

    Quantity

    90