Z-0906-2023 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 11, 2023
- Initiation Date
- November 28, 2022
- Termination Date
- March 18, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 320 units
Product Description
DeRoyal Tonsillectomy Tray, REF 89-10698.01
Reason for Recall
DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.
Distribution Pattern
Distribution in US states of VA, and SC.
Code Information
GTIN 50749756373222, Lots: 57466936 exp 8/1/2026; Lot 57897761 exp 6/1/2026