Events

Recall of Liver Access and Biopsy Needle Set

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
    74010
  • Event Risk Class
    Class 2
  • Event Number
    Z-2618-2016
  • Event Initiated Date
    2016-04-15
  • Event Date Posted
    2016-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145902
  • 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
    Biopsy needle - Product Code FCG
  • Reason
    Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
  • Action
    Cook Inc. sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter dated April 15, 2016, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with any medical questions or concerns, were instructed to contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. For information regarding the recall, please contact Stericycle Expert Solutions at 866.201.9067.

Device

Liver Access and Biopsy Needle Set
  • Model / Serial
    All Lots. Catalog prefixes LABS  Catalog/product number; Global/order number LABS-100 G08283 LABS-200 G08284 LABS-200-CHP-A G10590
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.
  • Product Description
    Liver Access and Biopsy Needle Set || Biopsy needle kit || Intended for use in obtaining liver histology samples via a jugular vein approach.
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Manufacturer Address
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA