Class 2 Device Recall WetField Hemostatic Eraser Bipolar 25G

• Date Initiated by Firm: February 26, 2018
• Create Date: May 10, 2018
• Recall Status: Terminated on October 30, 2019
• Recall Number: Z-1801-2018
• Recall Event ID: 79915
• 510(K)Number: K911160
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
• Code Information: Lot number: 6001035
• Recalling Firm/ Manufacturer: Beaver-Visitec International Inc.; 500 Totten Pond Rd; Waltham MA 02451-1916
• For Additional Information Contact: Max Cox; 781-906-8080
• Manufacturer Reason for Recall: Products were packaged with incorrect labeling,
• FDA Determined Cause: Labeling mix-ups
• Action: On 2/26/18 Beaver-Visitec emailed product recall notices to affected customers. Customers were instructed to destroy the affected product, provide objective evidence of the product destruction, then complete and return the customer response form. Customers with questions regarding this recall may contact Customer Service at (866)906-8080.
• Quantity in Commerce: 1025
• Distribution: US Nationwide and Canada
• 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 = GEI and Original Applicant = MENTOR O & O, INC.