BEUDAMED
    FDA Recall Terminated

    LIFECATH S PICC with Microflash Introducer Catheter, Percutaneous, Intravascular Product Code 2296.214 Product Usage: Intravascular catheter

    Recall: Z-2700-2011 · Initiated April 26, 2011

    Recall

    Recall Number
    Z-2700-2011
    Event Number
    58810
    Firm
    Vygon Corporation
    FEI Number
    2245270
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 26, 2011
    Posted
    June 29, 2011
    Terminated
    June 1, 2012
    Address
    103 A Park Drive, Montgomeryville, PA, 18936-9613

    Description

    LIFECATH S PICC with Microflash Introducer Catheter, Percutaneous, Intravascular Product Code 2296.214 Product Usage: Intravascular catheter

    Reason

    Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.

    Action

    Vygon Corporation sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 26, 2011. The letter identified the affected products, problem, and actions to be taken. The customers were instructed to check inventory and quarantine all affected products; immediately cease use and distribution of all affected products; return any affected products using the instruction from Customer Service involving product pickup (contact Customer Service at 1-800-473-5414 for a Return Merchandise Authorization number); and immediately complete and return the attached form via fax to 215-390-2019. Distributors were provided with instructions on how to handle products that were further distributed. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-,ail at [email protected].

    Distribution

    Nationwide Distribution--USA including states of: AZ, CA, FL, MO, NE, NJ, NY, PA, TX, UT, VA, and WA.

    Quantity

    600 individual units