Reported Oct 25, 2023 · Ongoing

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

DeRoyal Industries Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703

Is this the product you have?

  • DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Lot codes and dates
  • UDI/DI (GTIN) 74975659085
  • Lot Codes
    • 59205650 exp 11/1/2027
    • 59496207 exp 11/1/2027
Amount recalled
32 kits

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:52 PM UTC

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