FDA-Device2024-11-13Class II
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
DeRoyal Industries Inc
Hazard
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
Sold states
US Nationwide distribution in the state of OH.
Affected count
384 units
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0308-2025Don't want to check this manually?
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