FDA Recall
Terminated
CoolSeal Generator, REF: CSL-200-50
Recall: Z-0736-2022
·
Initiated January 25, 2022
Recall
- Recall Number
- Z-0736-2022
- Event Number
- 89570
- Firm
- Bolder Surgical, LLC
- FEI Number
- 3010377594
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 25, 2022
- Terminated
- May 15, 2024
- Address
- 331 S 104th St, Suite 200, Louisville, CO, 80027-9713
Description
CoolSeal Generator, REF: CSL-200-50
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.
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.
Distribution
US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
Quantity
10