Events

Recall of Device Recall Cook Flexor DL

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
    37115
  • Event Risk Class
    Class 2
  • Event Number
    Z-0377-2007
  • Event Initiated Date
    2007-01-05
  • Event Date Posted
    2007-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49934
  • 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
    endoscope - Product Code FED
  • Reason
    Lack of assurance of sterility, as the packages may not have been sealed.
  • Action
    Consignees were notified via recall letter dated 1/5/07 and requested to return the product.

Device

Device Recall Cook Flexor DL
  • Model / Serial
    Lot U1546391.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Massachusetts, Maine, New Hampshire and Puerto Rico.
  • Product Description
    Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
  • Manufacturer
    Cook Urological, Inc.

Manufacturer

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