Medications & Supplements/Prescription Drugs

B. Braun Medical Inc: 0.25% Acetic Acid Irrigation Recalled for Plastic Particle Contamination

Agency Publication Date: December 20, 2017

Summary

B. Braun Medical Inc. is recalling 2,576 containers of 0.25% Acetic Acid Irrigation USP (500 mL) due to the presence of visible particulate matter. The particles were identified as polyethylene, which is the same material used to manufacture the container's cap. This recall affects one specific lot of the irrigation solution, which is used for medical procedures like bladder rinsing.

Risk

If the contaminated solution is used on a patient, the plastic particles could cause local irritation, inflammation, or more serious complications if they enter the bloodstream or sensitive body cavities. While no injuries have been reported in the data, the presence of foreign material in a medical irrigation product poses a significant safety risk.

What You Should Do

Check your medical supplies for 500 mL plastic containers of 0.25% Acetic Acid Irrigation USP with NDC 0264-2304-10.
Verify if your product belongs to Lot Number J7N965 with an expiration date of 10/31/2020.
If you identify an affected container, stop using it immediately and set it aside to ensure it is not used in any medical procedures.
Contact your healthcare provider or pharmacist for guidance regarding the use of this product and to discuss alternative irrigation solutions.
Return any unused containers from the affected lot to the pharmacy or place of purchase for a refund and contact B. Braun Medical Inc. for further instructions on returning the product.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: 0.25% Acetic Acid Irrigation USP (500 mL)

Model:

NDC 0264-2304-10

Recall #: D-0112-2018

Lot Numbers:

J7N965 (Exp. 10/31/2020)

Date Ranges: 10/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78767

Status: Resolved

Manufacturer: B. Braun Medical Inc

Sold By: nationwide distributors

Manufactured In: United States

Units Affected: 2,576 containers

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 · 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.

Summary

Risk

What You Should Do

Check your medical supplies for 500 mL plastic containers of 0.25% Acetic Acid Irrigation USP with NDC 0264-2304-10.

Verify if your product belongs to Lot Number J7N965 with an expiration date of 10/31/2020.

If you identify an affected container, stop using it immediately and set it aside to ensure it is not used in any medical procedures.

Contact your healthcare provider or pharmacist for guidance regarding the use of this product and to discuss alternative irrigation solutions.

Return any unused containers from the affected lot to the pharmacy or place of purchase for a refund and contact B. Braun Medical Inc. for further instructions on returning the product.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.