Medications & Supplements/Prescription Drugs

Baxter Healthcare Corporation: 0.9% Sodium Chloride Irrigation Recalled for Potential Leaks and Sterility Loss

Agency Publication Date: January 24, 2020

Summary

Baxter Healthcare Corporation is recalling 22,336 bags of 0.9% Sodium Chloride Irrigation USP (5000 mL). The recall was initiated because the bags have the potential to leak, which compromises the sterility of the solution inside. This product is a prescription-only irrigation solution used for medical procedures, and its sterility is critical for patient safety.

Risk

If the irrigation bag leaks, the solution is no longer sterile and may be contaminated with bacteria or other pathogens. Using a non-sterile solution during medical procedures can lead to serious infections or other health complications for the patient.

What You Should Do

Immediately check your inventory for 0.9% Sodium Chloride Irrigation USP in 5000 mL bags with NDC 0338-0047-29.
Identify affected units by looking for Lot numbers Y309971 or Y309971A with an expiration date of 6/30/2021.
Stop using the affected product immediately and quarantine any remaining stock to prevent further use.
Contact your healthcare provider or pharmacist for guidance regarding any potential health concerns or if you have recently used this product.
Return any unused bags to the place of purchase or pharmacy for a refund and contact Baxter Healthcare Corporation at 1-888-229-8379 for further instructions on returning the product.
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

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

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

Affected Products

Product: 0.9% Sodium Chloride Irrigation USP (5000 mL bags)

Model:

NDC 0338-0047-29

Recall #: D-0517-2020

Lot Numbers:

Y309971 (Exp. date 6/30/2021)

Y309971A (Exp. date 6/30/2021)

Date Ranges: Expires 6/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84288

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 22336 bags

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

Immediately check your inventory for 0.9% Sodium Chloride Irrigation USP in 5000 mL bags with NDC 0338-0047-29.

Identify affected units by looking for Lot numbers Y309971 or Y309971A with an expiration date of 6/30/2021.

Stop using the affected product immediately and quarantine any remaining stock to prevent further use.

Contact your healthcare provider or pharmacist for guidance regarding any potential health concerns or if you have recently used this product.

Return any unused bags to the place of purchase or pharmacy for a refund and contact Baxter Healthcare Corporation at 1-888-229-8379 for further instructions on returning the product.

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