—#197109

Product

Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K033003
Affected lot / code info: UDI-DI: 30653405059930 Lot codes 202204294 202205134 202205164 202206084 202206154 202206204 202206304 202207074 202207084 202208014 202208044 202208084

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: ConMed Corporation
Address: 525 French Rd, Utica, New York 13502-5945

Distribution

Distribution pattern: Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.

Timeline

Recall initiated: 2022-11-18
Posted by FDA: 2022-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197109. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.