BEUDAMED
    FDA Recall Terminated

    Premier Edge MVR 19g Microsurgical Knife, Item PE-3519

    Recall: Z-0995-2007 · Initiated June 8, 2007

    Recall

    Recall Number
    Z-0995-2007
    Event Number
    38130
    Firm
    Oasis Medical Inc
    FEI Number
    2083373
    Product Code
    HNN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 8, 2007
    Posted
    July 4, 2007
    Terminated
    September 25, 2009
    Address
    510-528 South Vermont Ave, Glendora, CA, 91741

    Description

    Premier Edge MVR 19g Microsurgical Knife, Item PE-3519

    Reason

    This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.

    Action

    Notification of the recall sent to distributors and users. The 06/08/07 letter requests customers to notify down to the user level. Included in the Recall Notification Letter are instructions: "In addition, if you may have further distributed this product, please identify your customers and notify them at once ofthis product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any inconvenience."

    Distribution

    Worldwide, including USA, Switzerland, Germany, England, UK, Turkey, Czech Republic, and Lithuania.