DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Reported: October 25, 2023 Initiated: September 18, 2023 #Z-0116-2024
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.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 32 kits
- Distribution
- Pennsylvania
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit. Recalled by DeRoyal Industries Inc. Units affected: 32 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 25, 2023. Severity: Moderate. Recall number: Z-0116-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11