Events

Recall of fascial dilator

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

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
    32912
  • Event Risk Class
    Class 2
  • Event Number
    Z-1584-05
  • Event Initiated Date
    2005-08-01
  • Event Date Posted
    2005-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41065
  • 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
    Dilator, Urethral - Product Code KOE
  • Reason
    Mislabeled as to size.
  • Action
    The firm advised the hospital customers of the recall by phone on 7/6/05 and asked that the products be returned. One customer was sent a UPS call tag for return of the product and the other customer was requested to refuse receipt of their shipment in transit.

Device

fascial dilator
  • Model / Serial
    Lots 15-U1320351 and 15-U1320349.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California and Florida.
  • Product Description
    Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.
  • Manufacturer
    Cook Urological, Inc.

Manufacturer

Cook Urological, Inc.
  • Manufacturer Address
    Cook Urological, Inc., 1100 W Morgan St, Spencer IN 47460-9426
  • Source
    USFDA