—#155668

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

FDA product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K073496
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2017-05-03
Terminated: 2019-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155668. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.