Recall Z-0906-2023— DeRoyal Industries Inc
Class II · Terminated
Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2022-11-28, terminated 2026-03-18. FDA's recall record names no specific 510(k) clearance for this event. Product: DeRoyal Tonsillectomy Tray, REF 89-10698.01. Reason: 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..
- Recalling firm
- DeRoyal Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-11-28
- Terminated
- 2026-03-18
- Firm location
- Powell, TN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.