BEUDAMED
    FDA Enforcement Class II Terminated

    Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.

    Recall: Z-0051-2014 · Reported October 30, 2013

    Enforcement

    Recall Number
    Z-0051-2014
    Event ID
    65969
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synergetics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2013
    Initiation Date
    July 30, 2013
    Classification Date
    October 22, 2013
    Termination Date
    April 7, 2014
    Address
    3845 Corporate Centre Dr, N/A, O Fallon, MO, 63368-8678, United States

    Description

    Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.

    Reason

    One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.

    Code Info

    Lot number: M222240

    Distribution

    Nationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH.

    Quantity

    48/6-cannula boxes