FDAFDA · Food and drugs·Recall number Z-0736-2022
CoolSeal Generator, REF: CSL-200-50
Published March 16, 2022 · Recall initiated: January 25, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bolder Surgical, LLC
- Distributor
- US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
- Lot
- Serial Numbers: 00161-170, UDI: 00850346007023
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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