FDA-Device2023-01-11Class II
DeRoyal Tonsillectomy Tray, REF 89-10698.01
DeRoyal Industries Inc
Hazard
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.
Sold states
Distribution in US states of VA, and SC.
Affected count
320 units
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
DeRoyal Tonsillectomy Tray, REF 89-10698.01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0906-2023Don't want to check this manually?
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