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

Agency Publication Date: December 9, 2019

Summary

Baxter Healthcare Corporation is recalling 10 bags of its 0.9% Sodium Chloride Irrigation USP (5000 mL) in Arthromatic containers. This veterinary-use irrigation solution is being recalled because the containers have the potential to leak, which compromises the sterility of the fluid. The affected bags were distributed in Florida and are intended for irrigation only, not for injection.

Risk

A leak in the container allows outside contaminants to enter the solution, meaning the liquid is no longer sterile. Using non-sterile irrigation fluid during veterinary procedures can introduce bacteria or other pathogens directly into a patient's body, leading to serious infections.

What You Should Do

Locate your 5000 mL bags of 0.9% Sodium Chloride Irrigation USP in the Arthromatic Container (NDC 0338-0047-29).
Check the packaging for Lot Number Y309971 or Y309971A, both with an expiration date of June 30, 2021 (6/30/2021).
Immediately stop using any products that match these specific lot numbers and expiration dates.
Contact your veterinarian or healthcare provider if you have concerns about a procedure where this product may have been used.
Contact Baxter Healthcare Corporation at 1 Baxter Pkwy, Deerfield, Illinois, or call their customer service for specific instructions on returning the product and obtaining a refund.
Return any unused, affected bags to the place of purchase for a refund and contact the manufacturer for further instructions.
For additional questions or to report issues, contact the FDA Consumer Complaint Coordinator in your area or call the FDA at 1-888-INFO-FDA.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

Return for refund or guidance.

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

Option 2: Other Action

Manufacturer consultation.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

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

Model:

NDC 0338-0047-29

V-0330-2020

Lot Numbers:

Y309971 (Exp. 6/30/2021)

Y309971A (Exp. 6/30/2021)

Date Ranges: Exp. 6/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84310

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Sold By: Authorized distributors

Manufactured In: United States

Units Affected: 10 bags

Distributed To: Florida

Agency Last Updated: December 12, 2019

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

Summary

What You Should Do

Locate your 5000 mL bags of 0.9% Sodium Chloride Irrigation USP in the Arthromatic Container (NDC 0338-0047-29).

Check the packaging for Lot Number Y309971 or Y309971A, both with an expiration date of June 30, 2021 (6/30/2021).

Immediately stop using any products that match these specific lot numbers and expiration dates.

Contact your veterinarian or healthcare provider if you have concerns about a procedure where this product may have been used.

Contact Baxter Healthcare Corporation at 1 Baxter Pkwy, Deerfield, Illinois, or call their customer service for specific instructions on returning the product and obtaining a refund.

Return any unused, affected bags to the place of purchase for a refund and contact the manufacturer for further instructions.

For additional questions or to report issues, contact the FDA Consumer Complaint Coordinator in your area or call the FDA at 1-888-INFO-FDA.