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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

B. Braun Medical, Inc.: Perifix Epidural Anesthesia Sets Recalled for Potential Mislabeling

Agency Publication Date: September 21, 2023
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Summary

B. Braun Medical, Inc. is recalling 3,440 units of Perifix Epidural anesthesia sets because the product may have been mislabeled with an incorrect lid stock label. These medicated sets are used by healthcare professionals to administer anesthesia, and an incorrect label could lead to the use of an unintended device or medication. Consumers and healthcare providers should check their inventory for Lot Number 0061863524 with an expiration date of April 30, 2025.

Risk

Mislabeled medical devices pose a risk of procedural errors, as clinicians may unknowingly use incorrect components or medication concentrations, potentially leading to patient injury or ineffective treatment during anesthesia administration.

What You Should Do

  1. Immediately check your inventory for Perifix / Epidural anesthesia sets (medicated) with Product Code 332250 and UDI-DI 04046964178726.
  2. Verify if your product matches Lot Number 0061863524 with an expiration date of 30.APR.2025.
  3. If you identify affected units, stop using them immediately and set them aside to prevent accidental use.
  4. Contact your healthcare provider or B. Braun Medical, Inc. at their Allentown, PA headquarters for specific instructions regarding the return or exchange of the mislabeled products.
  5. For further information or to report any issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Manufacturer contact for product management

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

Affected Products

Product: Perifix / Epidural anesthesia set, medicated
Model / REF:
332250
UPC Codes:
04046964178726
Lot Numbers:
0061863524 (Exp 30.APR.2025)
Date Ranges: Expiration date 30.APR.2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92913
Status: Active
Manufacturer: B. Braun Medical, Inc.
Sold By: Medical distributors; Healthcare facilities
Manufactured In: United States
Units Affected: 3440 units
Distributed To: Arkansas, Arizona, California, Florida, Georgia, Illinois, Massachusetts, Missouri, North Carolina, New Jersey, Pennsylvania, Texas, Washington

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 · 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.