BEUDAMED
    FDA Enforcement Class II Terminated

    27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    Recall: Z-0887-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0887-2014
    Event ID
    67147
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synergetics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2014
    Initiation Date
    December 9, 2013
    Classification Date
    January 30, 2014
    Termination Date
    March 25, 2015
    Address
    3845 Corporate Centre Dr, O Fallon, MO, 63368-8678, United States

    Description

    27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    Reason

    Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.

    Code Info

    Lot number: M262090

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.

    Quantity

    96 units