Class 1 Device Recall Bipolar Pencil

• Date Initiated by Firm: November 14, 2024
• Date Posted: December 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0658-2025
• Recall Event ID: 95753
• 510(K)Number: K864402
• Product Classification: Electrosurgical cutting and coagulation; and accessories - Product Code GEI
• Product: Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
• Code Information: Model/Catalog Number: RX14-5011. GTINs: Pouch - 00841019109922, Inner Pack - 10841019109929, Case - 20841019109926. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.
• FEI Number: 1219619
• Recalling Firm/ Manufacturer: Kirwan Surgical Products, LLC; 180 Enterprise Dr; Marshfield MA 02050-2110
• For Additional Information Contact: Matthew R. Prario; US-781-8349500
• Manufacturer Reason for Recall: Potential for the outer stainless-steel tube to break or detach.
• FDA Determined Cause: Device Design
• Action: Kirwan Surgical Products notified customers on 11/14/2024 via URGENT MEDICAL DEVICE RECALL letter. Customers were instructed to return any affected units, notify all customer if affected product was further distributed and request they return them, and complete and return the Response Form provided in the notification.
• Quantity in Commerce: 3,010 units
• Distribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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