BEUDAMED
    FDA Recall Terminated

    Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.

    Recall: Z-1643-2009 · Initiated April 29, 2009

    Recall

    Recall Number
    Z-1643-2009
    Event Number
    51964
    Firm
    Alcon Laboratories, Inc
    FEI Number
    1610287
    Product Code
    NGY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 29, 2009
    Posted
    May 26, 2009
    Terminated
    October 14, 2009
    Address
    6201 South Fwy Fort, Worth, TX, 76134

    Description

    Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.

    Reason

    Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades.

    Action

    Firm began notifying consignees of recall by Urgent: Medical Device Recall letter on 04/29/09 (letters sent via FedEx). Consignees instructed to check inventory for affected lots; to complete and return the Medical Device Recall Response Form; to contact Alcon to arrange for return of the devices; that credit will be issued for the recalled product when it is returned; and in the case that there is no inventory remaining, to indicate that on the Response Form and return it as well. Consignees should contact Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8 for technical assistance.

    Distribution

    Worldwide Distribution -- USA and Canada.

    Quantity

    3,523 surgical paks.