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U.S. Department of Health and Human Services

Class 2 Device Recall Suction Coagulator

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  Class 2 Device Recall Suction Coagulator see related information
Date Initiated by Firm November 18, 2022
Date Posted December 09, 2022
Recall Status1 Open3, Classified
Recall Number Z-0474-2023
Recall Event ID 91165
510(K)Number K033003  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
Code Information UDI-DI: 30653405059930 Lot codes 202204294 202205134 202205164 202206084 202206154 202206204 202206304 202207074 202207084 202208014 202208044 202208084
Recalling Firm/
Manufacturer		 ConMed Corporation
525 French Rd
Utica NY 13502-5945
For Additional Information Contact Field Action Support Team
800-448-6506
Manufacturer Reason
for Recall		 Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.
FDA Determined
Cause 2		 Process control
Action On November 18, 2022, the firm notified affected customers through Urgent Medical Device Recall letters. Customers were instructed to review their inventory for any of the affected product and return affected product to the CONMED. Open or used devices should not be returned. If you have any questions or requests, please contact the Field Action Support Team at 1-800-448-6506 (8:00am to 7:00pm EST Monday through Friday) or email SC130187@conmed.com.
Quantity in Commerce 23,700 US; 5,225 OUS
Distribution Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = MODERN MEDICAL EQUIPMENT MFG., LTD.
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