CoolSeal Generator, REF: CSL-200-50
FDA Recall Z-0736-2022 · Posted None
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Recalling FirmBolder Surgical, LLC
Recall StatusTerminated
Product CodeGEI
Date Initiated2022-01-25
Date Terminated2024-05-15
Product Quantity10
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.
Firm Action
On 01/25/22, recall notices were hand delivered to U.S. customers and emailed to O.U.S. customers. Customers were asked to do the following: Discontinue use and return affected devices to the recalling firm, and complete and return the acknowledgment form. Customers with additional questions were encouraged to contact the recalling firm at 1-866-683-1743.
Root Cause
Process control
Distribution Pattern
US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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