Summary
The FDA issued a Class II for CoolSeal Generator, REF: CSL-200-50 by Bolder Surgical, LLC. Reason: A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can p.
Details
Source
Device Recall
External ID
Z-0736-2022
Action Date
2022-03-16
Status
Terminated
Category
device
Product Description
CoolSeal Generator, REF: CSL-200-50
Lot/Code Info: Serial Numbers: 00161-170, UDI: 00850346007023
Quantity Affected: 10
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.
Distribution
US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-25
Company
Louisville, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bolder Surgical, LLC has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bolder Surgical, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bolder Surgical, LLC have FDA actions?
Bolder Surgical, LLC has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0736-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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