Recall Z-0116-2024— DeRoyal Industries Inc

Name: FDA recall Z-0116-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-18

Class II · Ongoing

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2023-09-18. It names one FDA 510(k) clearance: K842648. Product: DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit. Reason: 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..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-09-18
Firm location: Powell, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K842648 — GENERAL SURGERY TRAYDeroyal Industries, Inc.·cleared 1984-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.