BEUDAMED
    FDA Recall Terminated

    Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring

    Recall: Z-0714-2017 · Initiated June 8, 2016

    Recall

    Recall Number
    Z-0714-2017
    Event Number
    74948
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    FEI Number
    3017892510
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    June 8, 2016
    Terminated
    June 15, 2018
    Address
    10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864

    Description

    Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring

    Reason

    There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.

    Action

    Angiodynamics, Inc. (Navilyst Medical, Inc.) sent an Urgent Voluntary Medical Device Recall letter dated June 8, 2016, with reply forms to all affected customers. Customers were advised to immediately remove any affected product from inventory, segregate and secure in a location for return. Immediately forward a copy of the recall notification to all sites to which they have distributed affected product. If affected product is located in your institution, please call Navilyst Medical Customer Service at 1-800-772-6446 8am-7pm, EST Monday - Friday to obtain a replacement or credit for your returned product. Promptly complete, sign and return the Reply Verification Tracking Form by email to [email protected] or by Fax to 1-800-782-1357. For questions regarding this recall call 518-792-4112.

    Distribution

    Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX

    Quantity

    48 cartons (boxes of 5)