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Terminated

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

FDA Recall Z-0474-2023 · Posted 2022-12-09

Recalling FirmConMed Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2022-11-18
Date Terminated2026-04-13
Product Quantity23,700 US; 5,225 OUS

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.

Firm 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 [email protected].

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033003SUCTION COAGULATORModern Medical Equipment Mfg., Ltd. · 2004-05-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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