BEUDAMED
    FDA Recall Terminated

    Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels.

    Recall: Z-0120-2010 · Initiated October 21, 2009

    Recall

    Recall Number
    Z-0120-2010
    Event Number
    53672
    Firm
    Thomas Medical Products Inc
    FEI Number
    3010665433
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 21, 2009
    Posted
    November 24, 2009
    Terminated
    November 8, 2010
    Address
    65 Great Valley Pkwy, Malvern, PA, 19355-1302

    Description

    Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels.

    Reason

    Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.

    Action

    An "Urgent Medical Device Correction" letter dated October 22, 2009 was issued to the direct accounts. The letter described the problem and actions for consignees. Consignees were instructed to cease distribution of the recalled product and to notify their subaccounts of the problem. In addition, customers were instructed to return the affected, unused product to Thomas Medical Product, Inc.'s contract warehouse, Inner-Space Warehouse, Inc. Contact your local sales representative for questions about the recall, or Customer Service by calling 1-866-446-3003, Monday through Friday from 8:30AM to 5:OOPM Eastern Standard Time, for questions about product return.

    Distribution

    United States (FL and MN).

    Quantity

    17,236 units