DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
FDA Recall #Z-0307-2025 — Class II — October 3, 2024
Product Description
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
Reason for Recall
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.
Recalling Firm
DeRoyal Industries Inc — Powell, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
160 units
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI/ DI 00749756916646 (each), 50749756916641 (case): Lot Numbers: lot 59839716 exp 12/1/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated