FDA-Device2022-03-16Class II
CoolSeal Generator, REF: CSL-200-50
Bolder Surgical, LLC
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.
Sold states
US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
Affected count
10
Manufactured in
331 S 104th St, Suite 200, Louisville, CO, United States
Products
CoolSeal Generator, REF: CSL-200-50
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0736-2022Don't want to check this manually?
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