CoolSeal Generator, REF: CSL-200-50
Reported: March 16, 2022 Initiated: January 25, 2022 #Z-0736-2022
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.
Details
- Recalling Firm
- Bolder Surgical, LLC
- Units Affected
- 10
- Distribution
- US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
- Location
- Louisville, CO
Frequently Asked Questions
What product was recalled? ▼
CoolSeal Generator, REF: CSL-200-50. Recalled by Bolder Surgical, LLC. Units affected: 10.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 16, 2022. Severity: Moderate. Recall number: Z-0736-2022.
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