Recall Z-0474-2023
ConMed Corporation · initiated November 18, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
Codes / lots: UDI-DI: 30653405059930 Lot codes 202204294 202205134 202205164 202206084 202206154 202206204 202206304 202207074 202207084 202208014 202208044 202208084
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: Process control
Action taken
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.
Details
- Recall number
- Z-0474-2023
- Initiated
- November 18, 2022
- Posted by FDA
- December 9, 2022
- Terminated
- April 13, 2026
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 23,700 US; 5,225 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.
- Recalling firm
- ConMed Corporation, Utica, NY