Recall of Device Recall OptiLite MultiUse Holmium Laser Fibers

Recall

77307

Class 2

Z-2585-2017

2017-05-03

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155668

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.

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.