BEUDAMED
    FDA Recall Terminated

    Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable Bimanuals Irrigation/Aspiration Set 19 Gauge, Dual Port; Item #1719-A - Disposable Bimanual Aspiration Handpiece 19g; Item #1719-I Disposable Bimanuals Irrigation/Aspiration Set, 19g, Open End; Item #1719-S Disposable Bimanuals Irrigation/Aspiration Set, 19g, Dual Port, Smooth. For use in cataract surgical procedures.

    Recall: Z-0740-2007 · Initiated April 9, 2007

    Recall

    Recall Number
    Z-0740-2007
    Event Number
    38120
    Firm
    Oasis Medical Inc
    FEI Number
    2083373
    Product Code
    KYG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 9, 2007
    Posted
    June 27, 2007
    Terminated
    October 6, 2011
    Address
    510-528 South Vermont Ave, Glendora, CA, 91741

    Description

    Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable Bimanuals Irrigation/Aspiration Set 19 Gauge, Dual Port; Item #1719-A - Disposable Bimanual Aspiration Handpiece 19g; Item #1719-I Disposable Bimanuals Irrigation/Aspiration Set, 19g, Open End; Item #1719-S Disposable Bimanuals Irrigation/Aspiration Set, 19g, Dual Port, Smooth. For use in cataract surgical procedures.

    Reason

    Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes.

    Action

    An April 9, 2007, notification of the recall will be sent to distributors and users. They are requested to notify down to the user (physician) 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 of this product recall. Your notification to your customers may be enhanced by induding 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, United Kingdom, Canada, Spain, Turkey, Kuwait, Colombia, Italy, Greece, Australia, Switzerland, South Africa, Germany, Portugal, and France.

    Quantity

    3050 total for all item numbers