Events

Recall of Device Recall Koyle Diaper Stent.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN.

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
    57708
  • Event Risk Class
    Class 2
  • Event Number
    Z-0966-2011
  • Event Initiated Date
    2010-12-13
  • Event Date Posted
    2011-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97062
  • 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
    urological device - Product Code KOD
  • Reason
    The firm received a complaint that 15 units of the koyle diaper stent were received in packages that had not been sealed. each stent should be sealed in a poly-tyvek pouch.
  • Action
    The firm sent an URGENT RECALL NOTICE to one consignee on 12/13/2010 (the other consignee returned all their product as a complaint). The letter informed the consignee of the recall and asked the customer to return the recalled product.

Device

Device Recall Koyle Diaper Stent.

Manufacturer

Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN
  • Manufacturer Address
    Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN, 1100 W Morgan St, Spencer IN 47460-9426
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA