BEUDAMED
    FDA Recall Terminated

    Tri-State Centurion Sutureless Multi-Lumen CVC Insertion Kit, sterile, 5 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder ECVC175.

    Recall: Z-1168-2009 · Initiated January 14, 2009

    Recall

    Recall Number
    Z-1168-2009
    Event Number
    50867
    Firm
    Tri-State Hospital Supply Corporation
    FEI Number
    1824619
    Product Code
    LRS
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 14, 2009
    Posted
    March 25, 2009
    Terminated
    December 31, 2009
    Address
    301 Catrell Drive, Howell, MI, 48843

    Description

    Tri-State Centurion Sutureless Multi-Lumen CVC Insertion Kit, sterile, 5 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder ECVC175.

    Reason

    Lack of assurance of sterility, as the package seals may be inadequate.

    Action

    Tri-State Hospital Supply Corporation notified all consignees via Urgent Product Recall Notice letter dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand, and to hold the product for retrieval.

    Distribution

    Nationwide.

    Quantity

    10