—#210455

Product

DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06

FDA product code: FDE — Laparoscopy Kit
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: UDI/ DI 00749756913393 (each), 50749756913398 (case): Lot Numbers: lot 59244907 exp 10/1/2025

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

DeRoyal issued an URGENT! DEROYAL RECALL NOTICE to its consignees on 10/03/2024 via email. The notice explained the issue, potential risk, and requested the return of the affected packs. If the affected product was further distributed, the notice directed the distributor to notify its customers. This may be achieved directly by forwarding the recall notification and notify DeRoyal that you have done so, or the distributor may provide DeRoyal with your customer listing allowing them to contact your customers.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: US Nationwide distribution in the state of OH.

Timeline

Recall initiated: 2024-10-03
Posted by FDA: 2024-11-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210455. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.