Medications & Supplements/Prescription Drugs

B. Braun Medical Inc: 0.9% Sodium Chloride Irrigation Recalled for Plastic Particulate Matter

Agency Publication Date: February 27, 2018

Summary

B. Braun Medical Inc. is recalling 17,360 containers of 0.9% Sodium Chloride Irrigation USP (sterile saline) in 1000 mL plastic irrigation containers. The recall was initiated after a customer complaint identified polyethylene plastic particles inside the solution, which appear to have come from the container's cap during manufacturing. This prescription product is used for medical irrigation, and the presence of foreign material could lead to serious medical complications if used during a procedure.

Risk

If the contaminated saline is used for irrigation, the plastic particles could cause inflammation, tissue granulomas (clumps of immune cells), or embolisms if the material enters the bloodstream or becomes trapped in tissues.

What You Should Do

Identify the affected product by checking the label for '0.9% Sodium Chloride Irrigation USP' in a 1000 mL Plastic Irrigation Container (PIC) with Catalog # R5200-01 and NDC 0264-2201-00.
Check the container for Batch # J7N912 and an expiration date of 10/31/20 to confirm it is part of the recall.
Immediately stop using any affected product from this specific batch and secure it to ensure it is not used in clinical settings.
Contact your healthcare provider or pharmacist for guidance regarding any potential concerns if the product was already used.
Contact B. Braun Medical Inc. at 1-800-227-2862 for instructions on how to return the unused product and to obtain a refund.
For additional questions, 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

Medical product refund and guidance

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

Affected Products

Product: 0.9% Sodium Chloride Irrigation USP (1000 mL)

Model:

Catalog # R5200-01

NDC 0264-2201-00

Recall #: D-0549-2018

Lot Numbers:

Batch # J7N912 (Exp 10/31/20)

Date Ranges: Expiration date 10/31/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79348

Status: Resolved

Manufacturer: B. Braun Medical Inc

Manufactured In: United States

Units Affected: 17,360 plastic irrigation 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

What You Should Do

Identify the affected product by checking the label for '0.9% Sodium Chloride Irrigation USP' in a 1000 mL Plastic Irrigation Container (PIC) with Catalog # R5200-01 and NDC 0264-2201-00.

Check the container for Batch # J7N912 and an expiration date of 10/31/20 to confirm it is part of the recall.

Immediately stop using any affected product from this specific batch and secure it to ensure it is not used in clinical settings.

Contact your healthcare provider or pharmacist for guidance regarding any potential concerns if the product was already used.

Contact B. Braun Medical Inc. at 1-800-227-2862 for instructions on how to return the unused product and to obtain a refund.

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