BEUDAMED
    FDA Recall Terminated

    Tri-State Hospital Supply Corp., Tri-State Centurion Venous Access Port Kits, Qty/case 20, sterile, Code No./Reorder KNV80. Each kit contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe, 10mL, REF # 8881590121.

    Recall: Z-1571-2009 · Initiated April 8, 2008

    Recall

    Recall Number
    Z-1571-2009
    Event Number
    52130
    Firm
    Tri-State Hospital Supply Corporation
    FEI Number
    1824619
    Product Code
    OKE
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    April 8, 2008
    Posted
    July 7, 2009
    Terminated
    November 19, 2009
    Address
    301 Catrell Drive, Howell, MI, 48843

    Description

    Tri-State Hospital Supply Corp., Tri-State Centurion Venous Access Port Kits, Qty/case 20, sterile, Code No./Reorder KNV80. Each kit contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe, 10mL, REF # 8881590121.

    Reason

    The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.

    Action

    Tri State Hospital notified their consignees by letter dated 4/8/08 and instructed to discontinue use of the product and to either discard or return it.

    Distribution

    Indiana, Mississippi, Ohio and Tennessee.

    Quantity

    100 kits