Bolder Surgical, LLC recalls CoolSeal Generator, REF: CSL-200-50
Recalled Product
CoolSeal Generator, REF: CSL-200-50
Hazard / Issue
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.
Issued by
FDA
Affected States: NY, MO, DE, PA, FL
Lot/Code Info: Serial Numbers: 00161-170, UDI: 00850346007023
View official government recall
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