BEUDAMED
    FDA Recall Terminated

    Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.), Product Code: 8-20302-10, Lot Number: 9L01N 20 gauge, 51 mm (2 in.) length non-coring deflected tip (Huber) needle, used with the LAP-BAND System for band adjustment.

    Recall: Z-2123-2011 · Initiated March 21, 2011

    Recall

    Recall Number
    Z-2123-2011
    Event Number
    58574
    Firm
    Allergan
    FEI Number
    2024601
    Product Code
    LTI
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    March 21, 2011
    Posted
    May 2, 2011
    Terminated
    April 6, 2012
    Address
    71 S Los Carneros Rd, Goleta, CA, 93117-5506

    Description

    Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.), Product Code: 8-20302-10, Lot Number: 9L01N 20 gauge, 51 mm (2 in.) length non-coring deflected tip (Huber) needle, used with the LAP-BAND System for band adjustment.

    Reason

    The recall was initiated because Allergan has determined that a number of Access Port Needle pouches from one specific lot number may have small gaps in a pouch seal. Consequently the product may no longer be sterile.

    Action

    Allegan sent an Urgent Medical Device Recall letter dated March 21, 2011, to all affected customers. Allergan requested that upon receipt of letter, that the customer check their existing inventory of product for affected lot. Customers were requested to complete Business Reply Card, stating quantity of inventory of affected lot, if any, and return to Allergan Medical. Customer with remaining inventory were instructed to contact Allergan Medical Product Support at 1-800-624-4261, x5972 or 1-805-961-5972 for return and immediate replacement. . Customers will be issued credit for returned product. For questions regarding this recall call 805-319-0589.

    Distribution

    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, MN, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Australia, Canada, Germany, Great Britian, and the Netherlands

    Quantity

    1878 x 10-packs