—#203391

Product

DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K842648
Affected lot / code info: UDI/DI (GTIN) 74975659085, Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027

Why it was recalled

DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

DeRoyal issued an URGENT RECALL NOTICE to its sole consignee on 09/18/2023 by email. The notice explained the problem, the risk to health, and requested the return of the product. Distributors were requested to notify their customers.

Recalling firm

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

Distribution

Distribution pattern: Pennsylvania

Timeline

Recall initiated: 2023-09-18
Posted by FDA: 2023-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203391. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.