Events

Recall of Device Recall Cook MultiUse Holmium Laser Fibers

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
    77304
  • Event Risk Class
    Class 2
  • Event Number
    Z-2539-2017
  • Event Initiated Date
    2017-05-09
  • Event Date Posted
    2017-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155666
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Reason
    Correction to the product instructions for use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
  • Action
    Cook is initiating a voluntary recall of multiple products in the form of a correction to the product Instructions for Use. Cook Inc. has identified the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. Potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. Cook distributed notices via courier on May 9, 2017. Customers were instructed to do the following: Distribution of the Cook Multi-Use Holmium Laser Fibers will not occur until the reprocessing instructions in the Instructions for Use have been corrected. Single use fibers are available. Contact your local sales representative for further information. You can continue to use your inventory of Cook Multi-Use Holmium Laser Fibers by following the attached Suggested Fiber Reprocessing Instructions. Action to be taken: 1. Examine your inventory immediately to identify and quarantine those affected products. 2. Implement the updated Suggested Fiber Reprocessing Instructions. 3. Return the required Acknowledgement and Receipt Form within 30 days. 4. Even if you do not have affected products, you must still complete the Acknowledgement and Receipt Form and send it via fax (812.339.7316) or email (fieldactionsna@cookmedical.com). 5. Immediately report any adverse events to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email at customerrelationsna@cookmedical.com. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: Online at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail) Call the FDA at: 1-800-FDA-1088 Should you have any medical questions or concer

Device

Device Recall Cook MultiUse Holmium Laser Fibers
  • Model / Serial
    HLF-M273-H30  HLF-M365-H30  HLF-M550-H30  HLF-M940-H30  HLF-M273-HSMA  HLF-M365-HSMA  HLF-M550-HSMA  HLF-M940-HSMA
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic: AL AR AZ CA CO FL GA HI ID IL IN KY LA MD MI MO MS NC NM NY OH OK OR PA SC TN TX UT VA WA WI Foreign: Austria, Australia, Argentina, Azerbaijan, Belgium, Bulgaria, Bahrain, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Djibouti, Egypt, France, Hong Kong, Honduras, Croatia, Greece, Germany, Hungary, India, Ireland, Italy, Latvia, Malaysia, Morocco, Netherlands, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Spain, Slovenia, South Africa, Sri Lanka, Sweden, Singapore, Taiwan, Thailand, Tunisia, United Kingdom, and Uruguay
  • Product Description
    Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
  • 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