BEUDAMED
    FDA Recall Terminated

    S5-7606 Silicone Oil injection Cannula 6mm Long - 20G REF 585247 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place

    Recall: Z-2164-2011 · Initiated December 17, 2010

    Recall

    Recall Number
    Z-2164-2011
    Event Number
    57472
    Firm
    Becton Dickinson and Company
    FEI Number
    1211998
    Product Code
    HMX
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    December 17, 2010
    Posted
    May 10, 2011
    Terminated
    July 3, 2013
    Address
    411 Waverley Oaks Rd, Ste 2229, Waltham, MA, 02452-8448

    Description

    S5-7606 Silicone Oil injection Cannula 6mm Long - 20G REF 585247 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place

    Reason

    Restricted or no fluid flow for Visitec High Viscosity Injector.

    Action

    Beaver Visitec (BVI) notified customers via telephone and by sending an Urgent Recall Customer Notification letter dated December 7, 2010. The letter identified the product, the problem, and the action to be taken by the customer. , Customers were requested to return all unused product in their inventory for credit or refund and complete the attached Customer Response Form and return it by fax to 781-893-7957. Questions can be directed to Inside Sales Manager at 781-906-7952.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Israel, Jordan, Russia, Saudi Arabia, South Africa, Turkey, Iraq, Lebanon, Morocco, Tunisia, Syria, India, Argentina, Australia, Austria, New Zealand, China, UK, Germany, Russia, Belgium, Italy, France, Sweden, and Ireland.

    Quantity

    1000 units