FDA recall Z-0474-2023

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2022-11-18

Report date

2022-12-21

Termination date

2026-04-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Utica, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0474-2023