Events

Recall of Device Recall Gastrostomy 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
    30433
  • Event Risk Class
    Class 2
  • Event Number
    Z-0327-05
  • Event Initiated Date
    2004-11-12
  • Event Date Posted
    2004-12-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35848
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code LNO
  • Reason
    Gastrostomy and jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
  • Action
    The recalling firm notified customers by letter, dated 11/12/04.

Device

Device Recall Gastrostomy kit.
  • Model / Serial
    Lots: 04639GZ00 and 17182GZ00.
  • Product Classification
    Gastroenterology-Urology Devices
  • Distribution
    The product was distributed throughout the United States and to foreign consignees located in Australia, Korea, Thailand, Venezuela, and Puerto Rico.
  • Product Description
    14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for Endoscopic Removal (list #00226). || Single Use Sterile Gastrostomy Kits.
  • Manufacturer
    Abbott Laboratories

Manufacturer

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