Baxter Recalls One Lot Over Potential Fiberglass Particles

Baxter is voluntarily recalling one lot of Anticoagulant Sodium Citrate Solution USP after potential fiberglass particulate matter was identified in the solution, according to a recall notice the Food and Drug Administration published on August 25, 2026.

The affected product is intended only for use with automated apheresis devices, which separate or collect components of blood. It is not intended for direct intravenous infusion. The lot was distributed from July 2 through July 11, 2026, to one customer in the United States. Baxter instructed that customer to immediately stop using the affected units and return them under facility procedures.

Which product is affected

The recall covers the 250 mL VIAFLEX Plastic Container presentation of Anticoagulant Sodium Citrate Solution USP. Facilities should check individual containers and cartons for these identifiers:

• Product code: 2B7867Q
• Lot number: Y493475
• NDC: 0338-9669-01
• Expiration date: December 31, 2027

The customer’s identity was not publicly disclosed in the selected recall information.

Why FDA and Baxter issued the recall

The concern is the potential presence of particulate matter identified as fiberglass in the solution. FDA and Baxter said that, without in-line filtration, possible risks could include local vein irritation, inflammatory or hypersensitivity reactions, and systemic embolization capable of injuring tissue or organs.

Those are potential risks described in the recall notice, not confirmed outcomes from this event. Baxter reported that it had received no related adverse-event reports as of August 25, 2026.

The recall does not apply to all Baxter citrate solutions or to all apheresis procedures. It concerns the identified lot and product presentation used with automated apheresis devices.

What affected facilities should do

Health-care facilities and apheresis operators should check their inventory for lot Y493475 and discontinue use of any affected units. Facilities should quarantine or return the product according to their internal procedures and Baxter’s instructions.

Operators should confirm that required in-line filtration is being used and that the device manufacturer’s operating instructions are being followed. Questions about the recall can be directed to the Baxter Healthcare Center for Service at 888-229-0001. The listed hours are 7 a.m. to 6 p.m. Central time, Monday through Friday.

Patients with questions about a procedure should contact the treating facility rather than try to identify or handle medical-supply inventory themselves. Adverse reactions or product-quality problems can be reported through FDA MedWatch.

What to watch next

The recall is voluntary and company-initiated, not an FDA-ordered seizure. FDA’s drug-recall records and Baxter’s product-update page may provide additional information if the company updates its instructions or if new customer or adverse-event information becomes available.

Sources

• FDA recall notice
• Baxter U.S. Important Product Updates
• AABB recall report

Look for updates to this story

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