Recall Z-0736-2022 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Bolder Surgical, LLC
CoolSeal Generator, REF: CSL-200-50
| Date | Jan 25, 2022 |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 10 |
| Distribution | US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202114 | CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, Bolder Surgical, LLC, Oct 6, 2020 |