Recall Z-0736-2022— Bolder Surgical, LLC

Name: FDA recall Z-0736-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-25

Class II · Terminated

Class II FDA medical device recall by Bolder Surgical, LLC, initiated 2022-01-25, terminated 2024-05-15. It names one FDA 510(k) clearance: K202114. Product: CoolSeal Generator, REF: CSL-200-50. Reason: 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..

Recalling firm: Bolder Surgical, LLC
Classification: Class II
Status: Terminated
Initiated: 2022-01-25
Terminated: 2024-05-15
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K202114 — CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20Bolder Surgical, LLC·cleared 2020-10-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CoolSeal Generator, REF: CSL-200-50

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.