Z-0736-2022 Class II Terminated
FDA device recall Z-0736-2022 was initiated by Bolder Surgical, LLC on January 25, 2022 and is designated Class II. 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… The recall status is terminated (terminated May 15, 2024). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2022
- Initiation Date
- January 25, 2022
- Termination Date
- May 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
CoolSeal Generator, REF: CSL-200-50
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.
Distribution Pattern
US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
Code Information
Serial Numbers: 00161-170, UDI: 00850346007023