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Bolder Surgical, LLC Recall 89570

Description: CoolSeal Generator, REF: CSL-200-50

Bolder Surgical, LLC Recall 89570 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0736-2022
Event ID89570
Event DescriptionCoolSeal Generator, REF: CSL-200-50
Product TypeDevices
DistributionUS: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
Recall ReasonA 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 Classification20220316
Device Code InfoSerial Numbers: 00161-170, UDI: 00850346007023
Center Classification Date20220308
Recall Initiation Date20220125
Recalling FirmBolder Surgical, LLC
Initial Notification Letter
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