Z-0474-2023 Class II Terminated
FDA device recall Z-0474-2023 was initiated by ConMed Corporation on November 18, 2022 and is designated Class II. 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 proced… The recall status is terminated (terminated April 13, 2026). Affected quantity: 23,700 US; 5,225 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2022
- Initiation Date
- November 18, 2022
- Termination Date
- April 13, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,700 US; 5,225 OUS
Product Description
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 Pattern
Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.
Code Information
UDI-DI: 30653405059930 Lot codes 202204294 202205134 202205164 202206084 202206154 202206204 202206304 202207074 202207084 202208014 202208044 202208084