Baxter (Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container/Baxter International Inc.) Recall reason: Potential presence of particulate matter[...]

COMPANY ANNOUNCEMENT

Baxter Issues Voluntary Nationwide Recall for One Lot of Anticoagulant Sodium Citrate Solution Due to Potential Presence of Particulate Matter

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Summary

Company Announcement

FOR IMMEDIATE RELEASE - AUG. 25, 2026 - DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Anticoagulant Sodium Citrate Solution due to the potential presence of particulate matter identified as fiberglass in the solution.

Risk Statement: Anticoagulant Sodium Citrate Solution is intended for use with automated apheresis devices. Administration of Anticoagulant Sodium Citrate containing particulate matter may lead to adverse health consequences, the extent and severity of harm depend on the size, number, morphology and composition of the foreign material. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory or hypersensitivity reactions, and systemic embolization that could result in tissue or organ injury. As of 8/25/2026, Baxter has not received any reports of adverse events related to this issue.

The product is intended for use only with apheresis devices. It is not for direct intravenous infusion and the directions for use are contained in the owners operating and maintenance manual of the apheresis machine to be used. The product is packaged in 250 mL VIAFLEX Plastic Containers, with 36 units per case. Additional information can be found in the table below.

Affected Product:

The affected lot can be identified by locating the lot number and expiration date on the individual product and shipping carton, as shown in the images below.

The impacted product was distributed from 7/2/2026 to 7/11/2026 to one customer in the United States.

The customer should immediately discontinue use of and return all affected units in accordance with their facility's process. Baxter is contacting the customer by email with instructions on how to identify and return the impacted product.

For general questions regarding this communication, please contact Baxter Healthcare Center for Service at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

The United States Food and Drug Administration (FDA) has been notified of this action.

• Content current as of:

  08/25/2026

• Regulated Product(s)

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