BEUDAMED
    FDA Recall Terminated

    10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442).

    Recall: Z-0960-05 · Initiated June 18, 2005

    Recall

    Recall Number
    Z-0960-05
    Event Number
    32425
    Firm
    Abbott Laboratories
    FEI Number
    1527460
    Product Code
    LNO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 18, 2005
    Posted
    July 7, 2005
    Terminated
    October 24, 2008
    Address
    6550 Singletree Dr, Columbus, OH, 43229-1119

    Description

    10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442).

    Reason

    The kits contain a 12 Fr. Introducer Tear-Away BNS component . The manufacturer of the component B. Braun Medical Inc., Allentown, PA notified Abbott Laboratories by letter dated 5/27/05, that the tearaway introducer sheaths may have cracked hubs/handles and/or improper peeling of the sheath during use in a small percentage of the affected lots.

    Action

    The recalling firm sent a device correction recall letter dated 6/16/05 by overnight courier to all consignees.

    Distribution

    The product was distributed to hospitals throughout the United States. Government accounts to which the product was distributed to were 2 Department of Defense accounts and 15 Veteran Administration centers including : Wilford Hall USAF Medical Center, 2200 Bergquist Dr., #1, Lackland AFB, TX 78236; WM Beaumont Army Medical Center, 5005 N. Piedras St., El Paso, TX 79920; Dallas VA Medical Center #549, 4500 S. Lancaster Rd. #44, Dallas, TX 75216; VA Hospital General Warehouse #648, 3710 SW US Vet Hospital Rd., Portland, OR 97201; VA Medical Center #558, 508 Fulton Street, Durham, NC 51442; VA Medical Center #605, 11201 Benton, Loma Linda, CA 92357; VA Medical Center, #630, 423 E. 23rd Street, New York, NY 10010; VA Medical Center #636, 4101 Woolworth Ave, Omaha, NE 51442; VA Medical Center #640, 3801 Miranda Ave., Palo Alto, CA 94304; VA Medical Center #650, 830 Chalkston Ave., Providence, RI 29080; VA Medical Center #662, 4150 Clement St., San Francisco, CA 94121; VA Medical Center #689, 950 Campbell Ave., West Haven, CT. 65160; VA Medical Center #521, 700 S. 19th Street, Birmingham, AL 35233; VA Medical Center Chief Supply, 113 Holland Ave., Albany, NY 12208; VA Medical Center #554, 1055 Clermont St., Denver, CO 80220; VA Medical Center #671, 7400 Merton Minter, San Antonio, TX 78284; Veterans Canteen SVC 587, 915 N. Grand Blvd., St. Louis, MO 63106.

    Quantity

    2,174 kits