BEUDAMED
    FDA Recall Terminated

    Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2) Insertion Kit, catalog number K12T-03050C; and (3) Angio Procedure Pack, catalog number K09T-09530A.

    Recall: Z-0413-2010 · Initiated May 19, 2009

    Recall

    Recall Number
    Z-0413-2010
    Event Number
    53619
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    3002975287
    Product Code
    KDD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 19, 2009
    Posted
    November 23, 2009
    Terminated
    December 3, 2009
    Address
    12701 N. Kingston Avenue, Chester, VA, 23836-2700

    Description

    Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2) Insertion Kit, catalog number K12T-03050C; and (3) Angio Procedure Pack, catalog number K09T-09530A.

    Reason

    Surgical gloves in hospital convenience kits may be degraded and tear during use.

    Action

    Merit Medical Systems notified customers by phone, fax, or visit by sales representatives on 05/19/09. The notification advised of the convenience kit correction due to the recall of the Derma Prene Ultra Surgical Gloves, and that use of the product should cease immediately. Sales representatives were instructed to provide replacement gloves and "warning" stickers to be placed on identified kits in inventory. The warning stickers advise the customer to discard the surgical gloves in the kit and replace. Customers were requested to verify product disposition by signing a response form.

    Distribution

    USA distribution: nine hospitals in Texas and Colorado.

    Quantity

    378 units