BEUDAMED
    FDA Recall 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 · Initiated December 9, 2013

    Recall

    Recall Number
    Z-0887-2014
    Event Number
    67147
    Firm
    Synergetics Inc
    FEI Number
    1000119053
    Product Code
    HQB
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    December 9, 2013
    Posted
    January 30, 2014
    Terminated
    March 25, 2015
    Address
    3845 Corporate Centre Dr, O Fallon, MO, 63368-8678

    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.

    Action

    Domestic customers were sent recall notices by FedEx on December 9, 2013. Foreign customers were sent recall notices by e-mail between December 6 and December 13, 2013. The recall notice instructed customers to return the recalled product.

    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