Events

Recall of Cook Medical Ciaglia Blue Dolphin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook, 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
    56084
  • Event Risk Class
    Class 1
  • Event Number
    Z-2084-2010
  • Event Initiated Date
    2010-04-21
  • Event Date Posted
    2010-07-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92656
  • 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
    Percutaneous Tracheostomy Introducer Set - Product Code JOH
  • Reason
    These set and/or tray products are being recalled because they include a covidien shiley 6perc or covidien shiley 8perc tracheostomy tube component that has been associated with cuff leakage as a result of the pilot balloon inflation assembly.
  • Action
    Cook Medical sent an Urgent Product Recall letter dated April 21, 2010, to hospitals and other user facilities receiving product direct from Cook as well as distribution centers receiving direct shipments from Cook. Consignees were directed to cease distribution of product and notify their customers immediately.

Device

Cook Medical Ciaglia Blue Dolphin
  • Model / Serial
    2459645, 2459647, and 2459648.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Canada, Mexico, Australia, Chile, Costa Rica, Denmark, Dominican Republic, Guatemala, India, Malaysia, Panama, Peru, Puerto Rico, Republic of Korea, Trinidad and Tobago, and Uruguay.
  • Product Description
    Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-G-PERC6, G53178.
  • Manufacturer
    Cook, Inc.

Manufacturer

Cook, Inc.
  • Manufacturer Address
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA