Recall Z-0474-2023 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Corporation
Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
| Date | Dec 9, 2022 (initiated Nov 18, 2022) |
| Status | Terminated |
| Reason | 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 | 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 | 23,700 US; 5,225 OUS |
| Distribution | Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033003 | SUCTION COAGULATOR Modern Medical Equipment Mfg., Ltd., May 13, 2004 |