Bolder Surgical, LLC Recall 89570
Description: CoolSeal Generator, REF: CSL-200-50
Bolder Surgical, LLC Recall 89570 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0736-2022 |
| Event ID | 89570 |
| Event Description | CoolSeal Generator, REF: CSL-200-50 |
| Product Type | Devices |
| Distribution | US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK |
| Quantity | 10 |
| Recall 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. |
| Device Classification | 20220316 |
| Device Code Info | Serial Numbers: 00161-170, UDI: 00850346007023 |
| Center Classification Date | 20220308 |
| Recall Initiation Date | 20220125 |
| Recalling Firm | Bolder Surgical, LLC |
| Initial Notification | Letter |
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