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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

DeRoyal Industries Inc: Head and Neck Surgical Kits Recalled for Damaged Syringe Packaging

Agency Publication Date: October 16, 2023
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Summary

DeRoyal Industries is recalling 32 of its DeRoyal Head and Neck procedure kits (model REF 89-4473) because they contain a B.Braun Medical Norm-Ject 2 Piece Syringe with a potentially damaged tip. This damage can puncture the sterile packaging barrier of the kit, compromising the safety of the surgical tools inside. These kits were distributed to Pennsylvania and include specific lot numbers 59205650 and 59496207. Consumers should stop using these specific kits and contact the manufacturer or their healthcare provider for instructions.

Risk

A damaged syringe tip can tear or puncture the sterile pouch of the surgical kit, allowing bacteria and other contaminants to enter. Using tools from a compromised sterile pack during surgery increases the risk of serious infection or other complications for the patient.

What You Should Do

  1. Locate your DeRoyal Head and Neck procedure kit and check the label for REF number 89-4473.
  2. Check the packaging for UDI/DI (GTIN) 74975659085 and Lot Codes 59205650 or 59496207 with an expiration date of 11/1/2027.
  3. Immediately stop using any kits that match these specific lot codes to avoid the risk of infection from non-sterile instruments.
  4. Contact your healthcare provider or DeRoyal Industries at 1-800-251-9864 to discuss the return of the affected products or for information regarding a potential refund.
  5. For additional questions, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Model / REF:
REF 89-4473
UPC Codes:
74975659085
Lot Numbers:
59205650 (Exp 11/1/2027)
59496207 (Exp 11/1/2027)
Date Ranges: Expires 11/1/2027

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93078
Status: Active
Manufacturer: DeRoyal Industries Inc
Sold By: authorized distributors
Manufactured In: United States
Units Affected: 32 kits
Distributed To: Pennsylvania

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.