Events

Recall of Device Recall LAPBAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

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

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
    58574
  • Event Risk Class
    Class 2
  • Event Number
    Z-2123-2011
  • Event Initiated Date
    2011-03-21
  • Event Date Posted
    2011-05-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99617
  • 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
    Implant, intragastric for morbid obesity - Product Code LTI
  • 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.

Device

Device Recall LAPBAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
  • Model / Serial
    Lot Number: 9L01 N
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • 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
  • Product 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.
  • Manufacturer
    Allergan

Manufacturer

Allergan