Class 2 Device Recall Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators

• Date Initiated by Firm: April 17, 2018
• Create Date: May 29, 2018
• Recall Status: Terminated on September 18, 2023
• Recall Number: Z-1952-2018
• Recall Event ID: 79762
• 510(K)Number: K890328
• Product Classification: Electrode, electrosurgical, active, urological - Product Code FAS
• Product: Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes and endoscopes.
• Code Information: All lots manufactured before December 7, 2017 UDI (00821925008700)
• Recalling Firm/ Manufacturer: Gyrus Acmi, Incorporated; 136 Turnpike Rd; Southborough MA 01772-2118
• For Additional Information Contact: Terry Sullivan; 508-804-2600
• Manufacturer Reason for Recall: There is a potential for the cord to spark and cause a fire.
• FDA Determined Cause: Device Design
• Action: Notification letters were distributed on April 17, 2018. The letters instruct customers to perform the following: Immediately assess any affected product you have in stock and replace the IFU with the revised IFU. Also ensure that any potential users of the devices are aware of the additional warning in the revised IFU. Future versions of the IFU will include the warning. Remove and discard all cords in use greater than one year. If you need additional copies of the IFU, call your Olympus customer service representative at 1-888-524-7266 to arrange for them to be provided. Please note on the enclosed Reply Form that you have received this information. Fax the completed Reply Form to 484-896-7128 regardless of whether you have any affected inventory at your facility. In addition, if you may have further distributed this product, please identify your customers, inform them at once of this action, provide the revised IFU and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this letter. For further questions, please call (508) 804-2600.
• Quantity in Commerce: 6447
• Distribution: Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Japan, Canada, Mexico, Australia, and EU.
• 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 = FAS