Reported Mar 16, 2022 · Terminated
CoolSeal Generator, REF: CSL-200-50
Bolder Surgical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bolder Surgical, LLC · 331 S 104th St · Louisville, CO · 80027-9713
Is this the product you have?
- CoolSeal Generator
- REFCSL-200-50
- Lot codes and dates
- Serial Numbers00161-170
- UDI00850346007023
- Amount recalled
- 10
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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