Class 2 Device Recall Cook MultiUse Holmium Laser Fibers

• Date Initiated by Firm: May 09, 2017
• Date Posted: June 05, 2017
• Recall Status: Terminated on January 26, 2018
• Recall Number: Z-2539-2017
• Recall Event ID: 77304
• 510(K)Number: K124030
• Product Classification: Powered laser surgical instrument - Product Code GEX
• Product: Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
• Code Information: HLF-M273-H30 HLF-M365-H30 HLF-M550-H30 HLF-M940-H30 HLF-M273-HSMA HLF-M365-HSMA HLF-M550-HSMA HLF-M940-HSMA
• FEI Number: 1820334
• Recalling Firm/ Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Departme; 812-339-2235
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• 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
• Quantity in Commerce: 4369
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = GEX