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Bolder Surgical, LLC recalls CoolSeal Generator, REF: CSL-200-50
Recalled March 16, 2022 · FDA recall Z-0736-2022 · Bolder Surgical
Hazard
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 Class II
Units
10
Sold at
US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
Description
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.
Product
CoolSeal Generator, REF: CSL-200-50
Manufacturer(s)
Bolder Surgical, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →