BEUDAMED
    FDA Enforcement Class II Terminated

    Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.

    Recall: Z-1968-2016 · Reported June 22, 2016

    Enforcement

    Recall Number
    Z-1968-2016
    Event ID
    73598
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Navilyst Medical, Inc., an AngioDyamics Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2016
    Initiation Date
    March 14, 2016
    Classification Date
    June 14, 2016
    Termination Date
    June 11, 2018
    Address
    10 Glens Falls Tech Park, Glens Falls, NY, 12801-3864, United States

    Description

    Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.

    Reason

    PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.

    Code Info

    Batch/Lots: 1) 4748893, 4766101, 4773293 & 4814220 with Use By Range 2016-05-31 to 2016-10-31. Batch/Lots: 2) 4752348, 4784466, 4735032, 4738833, 4765395 & 4814222 with Use By Range 2016-05-31 to 2016-07-31. Batch/Lots: 3) 4752881, 4765393 & 4942171 with Use By Range 2016-05-31 to 2017-09-30.

    Distribution

    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.

    Quantity

    2,260 units