BEUDAMED
    FDA Recall Terminated

    Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens

    Recall: Z-1802-2012 · Initiated May 11, 2012

    Recall

    Recall Number
    Z-1802-2012
    Event Number
    61945
    Firm
    Vygon Corporation
    FEI Number
    2245270
    Product Code
    NZW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 11, 2012
    Posted
    June 13, 2012
    Terminated
    March 11, 2013
    Address
    103 A Park Drive, Montgomeryville, PA, 18936-9613

    Description

    Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens

    Reason

    Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

    Action

    VYCON sent an URGENT MEDICAL DEVICE RECALL letter dated May 10, 2012, to all affected customers. The firm expanded their recall on May 25, 2012 by sending a second letter with additional lots and products. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory and quarantine any affected product. Customers should contact Vycon's Customer Service Department at 1-800-473-5414 for a Return Merchandise Authorization number. Customers were instructed to enter the number on the space provided on the Recall Acknowledgment and Inventory Return Form, sign and date form and fax to Vycon at 215-672-6740. Customers should return the affected product as well as the original signed Recall Acknowledgment and Inventory Form using the instructions from Customer Service involving product pick-up. All inventory will be credited. If product was further distributed the Urgent Medical Device Recall letter should be provided to their customers. For questions regarding this recall call 215-672-6740.

    Distribution

    Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.