Fiberglass Particles Prompt Baxter Recall of Anticoagulant Solution 2026

A single lot of a sterile anticoagulant solution used in blood and plasma collection has been pulled from distribution after Baxter International Inc. discovered the possible presence of fiberglass particles inside the product. The Deerfield, Illinois-based company announced the voluntary nationwide recall on August 25, 2026, warning that particulate contamination in a solution meant for use with automated apheresis devices can carry serious health risks if it is not caught before administration.

According to Baxter, if fiberglass particulate enters a patient’s bloodstream without being caught by in-line filtration, it could trigger local vein irritation, inflammatory or hypersensitivity reactions, or systemic embolization capable of damaging tissue or organs. The severity of any harm would depend on the size, number, shape and composition of the foreign material involved. As of the announcement date, Baxter said it had not received any reports of adverse events tied to the issue.

What Products Are Being Recalled?

The recall covers one lot of Anticoagulant Sodium Citrate Solution USP, packaged in 250 mL VIAFLEX plastic containers, with 36 units per case. The affected lot carries product code 2B7867Q, lot number Y493475, an expiration date of December 31, 2027, and NDC number 0338-9669-01. Facilities can confirm whether they have the recalled product by checking the lot number and expiration date printed on both the individual container and the outer shipping carton.

Why Was This Recall Issued?

Baxter identified the potential for fiberglass particulate matter within the solution itself. Because the product is designed for use exclusively with automated apheresis machines rather than for direct intravenous infusion, any contamination that bypasses filtration built into that equipment raises the risk of the complications described above. The company has not detailed how the fiberglass may have entered the solution, but it moved quickly to notify regulators and the affected customer once the issue was identified.

Who Is Affected?

Distribution of the recalled lot was limited. Baxter says the product shipped between July 2, 2026, and July 11, 2026, to just one customer in the United States. Because apheresis solutions of this type are used almost exclusively in clinical and blood-collection settings rather than sold to individual consumers, the recall’s direct footprint is narrow, though the FDA has posted the notice publicly as required for drug recalls of this nature.

What Should You Do?

Any facility holding units from lot Y493475 should immediately stop using the product and return all affected units according to its own internal recall procedures. Baxter says it is contacting the impacted customer directly by email with specific instructions on how to identify and return the product. Facilities with questions can reach Baxter Healthcare Center for Service at 888-229-0001, available 7:00 a.m. to 6:00 p.m. Central Time, Monday through Friday.

Healthcare providers or facilities that experienced any adverse reaction or quality problem connected to this product are encouraged to report it to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online at the FDA’s MedWatch portal, or by downloading a reporting form to submit by mail or fax to 1-800-FDA-0178.

Official Statement

Baxter’s public notice, issued under the heading ‘FOR IMMEDIATE RELEASE,’ states that the company is voluntarily recalling the lot ‘due to the potential presence of particulate matter identified as fiberglass in the solution.’ The company confirmed that the FDA has been notified of the action. Media inquiries can be directed to Baxter spokesperson Brenna Byrne at (224) 948-5353 or via email at media@baxter.com.

Because this is a drug product regulated under the FDA’s authority, the recall is documented on the agency’s official recalls page as a company-issued announcement rather than an FDA-initiated action, though the agency has acknowledged receiving notice of it.