Z-0116-2024Class II

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

Name: Z-0116-2024 DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Creator: DeRoyal Industries Inc
Published: 2023-09-18
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2023-09-18 / Open, Classified / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit on 2023-09-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0116-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-18
Posted: 2023-10-16
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Product code: LRO General Surgery Tray
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 32 kits
Distribution: Pennsylvania
Product codes and lots: UDI/DI (GTIN) 74975659085, Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0116-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0116-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-25	2023-10-16

Product code LRO

K842648Class IIGeneral Surgery TrayDeroyal Industries, Inc. / cleared 1984-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)