Medications & Supplements/Prescription Drugs

Baxter Healthcare Corporation: 0.9% Sodium Chloride Injection Recalled for Potential Leaks and Sterility Risk

Agency Publication Date: July 23, 2019

Summary

Baxter Healthcare Corporation is recalling approximately 139,680 containers of 0.9% Sodium Chloride Injection USP (saline solution) sold in 100 mL Viaflex containers. The recall was issued because the bags have the potential to leak, which compromises the sterility of the medication. These prescription IV bags were distributed nationwide throughout the United States and Puerto Rico. Consumers and healthcare providers should immediately identify and stop using the affected saline bags and contact their pharmacist or healthcare provider for a refund and replacement.

Risk

If the IV bags leak, the sterility of the saline solution cannot be guaranteed. Injecting a non-sterile solution directly into the bloodstream poses a serious risk of infection and other health complications for patients.

What You Should Do

Identify if you have 100 mL Viaflex containers of 0.9% Sodium Chloride Injection USP by checking the label for National Drug Code (NDC) 0338-0049-38.
Check the packaging for lot numbers P389684 or P389742, both of which carry an expiration date of August 31, 2020 (8/31/2020).
Immediately stop using any saline bags that match these lot numbers and expiration dates.
Contact your healthcare provider or pharmacist for guidance on alternative treatments and instructions on how to return the unused product to the pharmacy for a refund.
Contact Baxter Healthcare Corporation at 1 Baxter Pkwy, Deerfield, IL 60015 for further information regarding this recall.
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

Refund for unused recalled saline bags.

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 Injection USP (100 mL Viaflex Container)

Model:

NDC 0338-0049-38

Lot Numbers:

P389684 (Exp. 8/31/2020)

P389742 (Exp. 8/31/2020)

Date Ranges: Expiration date 8/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83340

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Sold By: hospitals; pharmacies; medical distributors

Manufactured In: United States

Units Affected: 139,680 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 if you have 100 mL Viaflex containers of 0.9% Sodium Chloride Injection USP by checking the label for National Drug Code (NDC) 0338-0049-38.

Check the packaging for lot numbers P389684 or P389742, both of which carry an expiration date of August 31, 2020 (8/31/2020).

Immediately stop using any saline bags that match these lot numbers and expiration dates.

Contact your healthcare provider or pharmacist for guidance on alternative treatments and instructions on how to return the unused product to the pharmacy for a refund.

Contact Baxter Healthcare Corporation at 1 Baxter Pkwy, Deerfield, IL 60015 for further information regarding this recall.

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.