BEUDAMED
    FDA Recall Terminated

    Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector

    Recall: Z-0715-2013 · Initiated December 20, 2012

    Recall

    Recall Number
    Z-0715-2013
    Event Number
    63959
    Firm
    Medisystems a NX Stage Company
    FEI Number
    3003464075
    Product Code
    FIE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    December 20, 2012
    Posted
    January 24, 2013
    Terminated
    October 10, 2013
    Address
    350 Merrimack St, Lawrence, MA, 01843-1748

    Description

    Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector

    Reason

    Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge

    Action

    Medisystems sent a notification letter dated December 20, 2012 to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to immediately open and inspect inventory for the affected products. Results of the inspection are to be provided to Medisystems and the product is to be returned to Medisystems. For questions call (978) 332-5973.

    Distribution

    US Nationwide Distribution in the states of NY, PA and TN.

    Quantity

    16 cases (15 cs x 250 ea) 4,000 needles