BEUDAMED
    FDA Recall Terminated

    AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102805 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.

    Recall: Z-0885-2012 · Initiated January 9, 2012

    Recall

    Recall Number
    Z-0885-2012
    Event Number
    60909
    Firm
    Angiodynamics Worldwide Headquarters
    FEI Number
    3008319439
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 9, 2012
    Posted
    January 26, 2012
    Terminated
    February 5, 2016
    Address
    14 Plaza Drive, Latham, NY, 12110-3421

    Description

    AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102805 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.

    Reason

    The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.

    Action

    AngioDynamics, Inc. sent an Urgent - Medical Device Recall letter dated January 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and segragate the recalled affected product. Complete the enclosed Morpheus Ct PICC Recall Reply Form and fax it to the attention of the Morpheus CT PICC Recall Coordinator at 518-798-1360. If customers do not have any affected product remaining in their possession they should fill out the attached form noting zero quantity to be returned and fax the form to 518-798-1360. If customers distributed the affected product, they should inform their customers of this recall action immediately and have them return the recalled units to them. For any questions regarding this recall call 1-800-772-6446 or e-mail [email protected].

    Distribution

    Nationwide

    Quantity

    1995 units