FDA-Device2023-10-25Class II
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
DeRoyal Industries Inc
Hazard
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.
Sold states
Pennsylvania
Affected count
32 kits
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0116-2024Don't want to check this manually?
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