BEUDAMED
    FDA Recall Terminated

    Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure

    Recall: Z-1794-2017 · Initiated March 16, 2017

    Recall

    Recall Number
    Z-1794-2017
    Event Number
    76774
    Firm
    Windstone Medical Packaging, Inc.
    FEI Number
    1000125955
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 16, 2017
    Posted
    April 11, 2017
    Terminated
    June 6, 2017
    Address
    1602 4th Ave N, Billings, MT, 59101-1521

    Description

    Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure

    Reason

    AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

    Action

    AMS sent an Urgent Medical Device Recall letter dated March 16, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit. Customers should check inventory and complete the Recall Reply Form. Fax the completed form to Aligned Medical Solutions at 407-804-8460 or email the completed form to [email protected]. Customers can call Aligned Medical Solutions at 321-527-7714.

    Distribution

    Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

    Quantity

    169 packs