BEUDAMED
    FDA Recall Terminated

    Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.

    Recall: Z-1682-2013 · Initiated May 15, 2013

    Recall

    Recall Number
    Z-1682-2013
    Event Number
    65183
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    LJH
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    May 15, 2013
    Posted
    July 10, 2013
    Terminated
    June 16, 2015
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.

    Reason

    A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.

    Action

    Baxter sent an Urgent Product Recall letter dated May 15, 2013 to all affected custorners. The letter identified the affected product, problem and actions to be taken. Customers were requested to remove all affected products and return for credit by contacting Baxter Healthcare Center for Service at 888-229-0001. Customers were instructed to complete the attached Customer Reply Form and return it to Baxter by either faxing to 224-270-5457 or scanning and e-mailing the reply form to [email protected]

    Distribution

    US Nationwide Distribution

    Quantity

    356,728 units