Class 2 Device Recall CoolSeal Generator

• Date Initiated by Firm: January 25, 2022
• Create Date: March 08, 2022
• Recall Status: Terminated on May 15, 2024
• Recall Number: Z-0736-2022
• Recall Event ID: 89570
• 510(K)Number: K202114
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: CoolSeal Generator, REF: CSL-200-50
• Code Information: Serial Numbers: 00161-170, UDI: 00850346007023
• Recalling Firm/ Manufacturer: Bolder Surgical, LLC; 331 S 104th St; Suite 200; Louisville CO 80027-9713
• For Additional Information Contact: 866-683-1743
• Manufacturer Reason for Recall: A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of unintended energy to the patient.
• FDA Determined Cause: Process control
• Action: On 01/25/22, recall notices were hand delivered to U.S. customers and emailed to O.U.S. customers. Customers were asked to do the following: Discontinue use and return affected devices to the recalling firm, and complete and return the acknowledgment form. Customers with additional questions were encouraged to contact the recalling firm at 1-866-683-1743.
• Quantity in Commerce: 10
• Distribution: US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
• 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 = Bolder Surgical, LLC