BEUDAMED
    FDA Recall Terminated

    CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.

    Recall: Z-2474-2015 · Initiated February 25, 2013

    Recall

    Recall Number
    Z-2474-2015
    Event Number
    64928
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    KDJ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 25, 2013
    Posted
    August 27, 2015
    Terminated
    March 8, 2016
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.

    Reason

    Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.

    Action

    Baxter sent an IMPORTANT PRODUCT INFORMATION letters dated February 25, 2013 to affected customers via USPS. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached reply form and return it to Baxter by faxing it to 224-270-5457 of scanning the form and e-mailing it to [email protected]. For general questions about this communication can be answered by contacting The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST). Clinical questions can be answered by calling Baxter's Renal Division Clinic Help line at 888-736-2543 x 2 (Monday - Friday, 8:00 AM - 5:00 PM CST).

    Distribution

    Worldwide Distribution - US: Nationwide + American Samoa + District of Columbia + Guam + Northern Mariana Islands + Puerto Rico; *** FOREIGN: Antigua, Argentina, Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Chile, Colombia, Cuba, Curacao, Dominican Republic, Ecuador, El Salvador, France (New Caledonia), Guatemala, Guyana, Honduras, Hong Kong, India, Indonesia, Jamaica, Japan, Macau, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Suriname, Taiwan, Thailand, Trinidad and Tobago, United Kingdom (Cayman Islands), Uruguay, Venezuela

    Quantity

    35,460 units