CoolSeal Generator recall
CoolSeal Generator, REF: CSL-200-50
Why was CoolSeal Generator 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 00161-170, UDI: 00850346007023
- Product
- CoolSeal Generator, REF: CSL-200-50
- Recalling firm
- Bolder Surgical, LLC
- Quantity
- 10
- Distribution
- US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
- Recall date
- March 16, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)