Events

Recall of Device Recall Jejunostomy Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    32425
  • Event Risk Class
    Class 2
  • Event Number
    Z-0960-05
  • Event Initiated Date
    2005-06-18
  • Event Date Posted
    2005-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40049
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    unknown device name - Product Code LNO
  • 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.

Device

Device Recall Jejunostomy Kit
  • Model / Serial
    Lot 13978GZ, exp. date 02/01/2007; Lot 17165GZ, exp. date 06/01/2007; Lot 18190GZ, exp. date 07/01/2007; Lot 19257GZ, exp. date 08/01/2007; Lot 22355, exp. date 11/01/2007; Lot 24440GZ, exp. date 01/01/2008; Lot 26509GZ, exp. date 02/01/2008; Lot 27530GZ, exp. date 02/01/2008
  • 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.
  • Product Description
    10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442).
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 6550 Singletree Dr, Columbus OH 43229-1119
  • Source
    USFDA