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Open, Classified

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

FDA Recall Z-0116-2024 · Posted 2023-10-16

Recalling FirmDeRoyal Industries Inc
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2023-09-18
Product Quantity32 kits

Reason for Recall

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.

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Pennsylvania

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K842648GENERAL SURGERY TRAYDeroyal Industries, Inc. · 1984-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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