BEUDAMED
    FDA Recall Terminated

    OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604 Dual Tip Irrigator 8 Ports The Dual tip Irrigator 8 Ports is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a Tyvek pouch, heat-sealed and sterilized. After sterilization, 10 pouches are loaded into a carton, the carton is labeled and heat-shrink wrapped.

    Recall: Z-1599-05 · Initiated August 24, 2005

    Recall

    Recall Number
    Z-1599-05
    Event Number
    33431
    Firm
    Oasis Medical Inc
    FEI Number
    2083373
    Product Code
    KYG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 24, 2005
    Posted
    October 1, 2005
    Terminated
    March 24, 2014
    Address
    512 S Vermont Ave, Glendora, CA, 91741-6205

    Description

    OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604 Dual Tip Irrigator 8 Ports The Dual tip Irrigator 8 Ports is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a Tyvek pouch, heat-sealed and sterilized. After sterilization, 10 pouches are loaded into a carton, the carton is labeled and heat-shrink wrapped.

    Reason

    "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators

    Action

    OASIS Medical shall inform all customers that have received the product via FAX and Certified Mail to cease use immediately and return all unused product to OASIS.

    Distribution

    Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland

    Quantity

    9,859 cannulas for all codes