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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

B. Braun Medical, Inc.: Epidural Trays Recalled for Incorrect Connectors and Component Mismatch

Agency Publication Date: February 16, 2024
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Summary

B. Braun Medical, Inc. is recalling 7,370 PERIFIX Epidural Trays because they contain the wrong type of filter straws. The kits were supposed to include straws with standard Luer connections, but instead contain Neuraxial connectors, which prevent the straw from connecting to other essential parts in the kit. This defect can delay medical procedures or prevent the administration of pain medication. These kits were distributed nationwide across the United States between late 2023 and early 2024.

Risk

The incompatible connectors prevent the filter straw from interfacing with other kit components, which can lead to delays in treatment or the inability to administer necessary anesthetic or analgesic medication during epidural procedures.

What You Should Do

  1. Check your medical supplies for PERIFIX Epidural Trays with Product Code 332079, Lot Number 0061855319, and an expiration date of April 30, 2024.
  2. Check your medical supplies for PERIFIX Epidural Trays with Product Code 332248, Lot Number 0061855122, and an expiration date of October 25, 2024.
  3. Immediately identify and quarantine any affected kits to ensure they are not used in clinical procedures.
  4. Contact your healthcare provider or B. Braun Medical, Inc. for further instructions regarding the return or replacement of these trays and to obtain a potential refund.
  5. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

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: PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)
Model / REF:
332079
UPC Codes:
04046964177224
Lot Numbers:
0061855319
Date Ranges: Exp. Date: 30.APR.2024
Product: PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit)
Model / REF:
332248
UPC Codes:
04046964178689
Lot Numbers:
0061855122
Date Ranges: Exp. Date: 25.OCT.2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93889
Status: Active
Manufacturer: B. Braun Medical, Inc.
Manufactured In: United States
Units Affected: 2 products (3,480 units; 3,890 units)
Distributed To: Nationwide

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.