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FDA (Device enforcement)Recalled 2024-10-03class ii

DeRoyal Industries Inc: DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06

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.

Details from the source

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. Distribution: US Nationwide distribution in the state of OH. Quantity: 160 units Lot/code info: UDI/ DI 00749756916646 (each), 50749756916641 (case): Lot Numbers: lot 59839716 exp 12/1/2025

UPC codes

00749756916646, 50749756916641

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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