BEUDAMED
    FDA Recall Terminated

    Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)

    Recall: Z-1010-2015 · Initiated January 14, 2015

    Recall

    Recall Number
    Z-1010-2015
    Event Number
    70102
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    OCX
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    January 14, 2015
    Posted
    January 26, 2015
    Terminated
    April 10, 2017
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)

    Reason

    Potential for failure of the pouch packaging seal at high altitudes.

    Action

    1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 AM and 6:00 PM Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number(s) and quantity of product to be returned ready when calling. 3. Complete the enclosed Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing to [email protected] . Returning the Customer Reply Form promptly will prevent you from receiving repeat notices. 4. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 5. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers. If product was purchased from a distributor: 1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 AM and 6:00 PM Central Time, Monday through Friday. 3. Follow your supplier's recall and response process. Please do not return the customer reply form to Baxter.

    Distribution

    US Distribution.

    Quantity

    26,028 units