Recall archive / FDA device enforcement
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit — FDA record Z-0116-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 18, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 32 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0116-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI (GTIN) 74975659085, Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Pennsylvania
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 25, 2023
- Recall initiation date
- Sep 18, 2023
- Center classification date
- Oct 16, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.