Class 2 Device Recall OptiLite MultiUse Holmium Laser Fibers

• Date Initiated by Firm: May 03, 2017
• Create Date: June 14, 2017
• Recall Status: Terminated on March 26, 2019
• Recall Number: Z-2585-2017
• Recall Event ID: 77307
• 510(K)Number: K073496
• Product Classification: Powered laser surgical instrument - Product Code GEX
• Product: OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages; ; Product Usage:; Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation
• Code Information: OptiLite Multi-Use Holmium Laser Fibers, Catalog Numbers followed by GPN: HLF-M273-CNV, G48611 HLF-M273-SMA, G48522 HLF-M365-CNV, G48613 HLF-M365-SMA, G48618 HLF-M550-CNV, G48615 HLF-M550-SMA, G48619 HLF-M940-CNV, G48617 HLF-M940-SMA, G48621 HLF-M273-CNV-CAN, G51777 HLF-M273-SMA-CAN, G51785 HLF-M365-CNV-CAN, G51778 HLF-M365-SMA-CAN, G51786 HLF-M550-CNV-CAN, G51779 HLF-M550-SMA-CAN, G51787 HLF-M940-CNV-CAN, G51780 HLF-M940-SMA-CAN, G51788
• 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: Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently 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 because they have identified the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. Notices were sent to customers on May 03, 2017 via courier. Customers were asked to do the following: Please contact your local Cook representative for suggested product alternatives to use. FAR2017-030 Page 2 of 2 Action to be taken: 1. Examine your inventory immediately to identify and quarantine those affected products. 2. Return the required Acknowledgement and Receipt Form indicating quantities, part numbers, and lot numbers of affected products within 30 days. 3. Return or discard any affected products. (Instructions regarding product returns are listed in the attached Acknowledgement and Receipt Form.) 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 This notice must be shared with appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred. Should you have any medical questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
• Quantity in Commerce: 10,415
• Distribution: Worldwide Distribution - US Nationwide in the states of: AK AL AZ CA CO FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC NJ NY OH OR PA SC SD TN TX WA WI Foreign: Australia, Bolivia, Brazil, Canada, Chile, Columbia, Cyprus, Czech Republic, Germany, Dominican Republic, Greece, Hong Kong, Ireland, Israel, India, Iran, Jordan, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Latvia, Libya, Mexico, Malaysia, New Zealand, Oman, Panama, Peru, Portugal, Serbia, Turkey, Trinidad and Tobago, Taiwan, and Venezuela. VA/DOD: Yes- see below
• 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 and Original Applicant = COOK UROLOGICAL, INC.