FDA Recall: Baxter Anticoagulant Sodium Citrate Solution for Potential presence of particulate matter identified as fiberglass in the solution
Source: FDA
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FDA Recall: Baxter Anticoagulant Sodium Citrate Solution for Potential presence of particulate matter identified as fiberglass in the solution

Baxter August 26, 2026

Baxter Recalls Anticoagulant Sodium Citrate Solution Over Fiberglass Contamination

Urgent Safety Notice: Baxter International Inc. has announced a voluntary, nationwide recall of one lot of Anticoagulant Sodium Citrate Solution USP (250 mL VIAFLEX). Routine quality testing discovered fiberglass particles in the solution, creating potential risks such as vein irritation, hypersensitivity reactions, or embolization. End users holding lot Y493475 should immediately stop use and follow the return instructions provided below.

Quick-Reference Recall Facts

  • Manufacturer: Baxter International Inc.
  • Product Name: Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container
  • FDA Recall Publication Date: August 25 2023
  • Reason for Recall: Possible fiberglass particulate contamination
  • Affected Lot: Y493475
  • Product Code: 2B7867Q
  • NDC: 0338-9669-01
  • Expiration Date: 31-Dec-2027
  • Distribution Window: July 2 – 11 2023 (single U.S. customer)

Sources

Potential Health Hazards of Fiberglass Particles

If fiberglass particulate matter from the recalled Baxter Anticoagulant Sodium Citrate Solution enters an apheresis system and subsequently a patient’s bloodstream, it may trigger:

  • Localized vein irritation at the infusion site
  • Inflammatory or hypersensitivity responses
  • Systemic embolization that can damage tissues or organs

As of the FDA publication date, Baxter had received no reports of injuries or adverse events related to this lot.

Immediate Actions for Facilities and Clinicians

  1. Identify and quarantine all inventory labeled with lot number Y493475.
  2. Process returns through your normal channel and ship affected units back to Baxter.
  3. For assistance, contact Baxter Healthcare Center for Service at 888-229-0001 (7 a.m.–6 p.m. CT, Monday–Friday).
  4. Report any suspected adverse reactions to the FDA MedWatch program online at fda.gov/medwatch/report.htm, by mail, or via fax 1-800-FDA-0178.

Recall Images Provided by the FDA

Label for Baxter Anticoagulant Sodium Citrate Solution, 250 mL VIAFLEX
Image credit: U.S. Food & Drug Administration
Carton of Baxter Anticoagulant Sodium Citrate Solution
Image credit: U.S. Food & Drug Administration

Frequently Asked Questions

Why did Baxter recall Anticoagulant Sodium Citrate Solution lot Y493475?

Quality testing detected fiberglass fragments in the Baxter Anticoagulant Sodium Citrate Solution lot Y493475. These particles pose a risk of irritation, allergic reaction, or embolization if infused, prompting the voluntary recall.

How do I confirm that my Baxter Anticoagulant Sodium Citrate Solution is part of the recall?

Check both the overwrap and carton for lot number Y493475 and expiration date 31-Dec-2027. Only this single lot of Baxter Anticoagulant Sodium Citrate Solution is affected.

Was Baxter Anticoagulant Sodium Citrate Solution sold directly to patients?

No. The recalled Baxter Anticoagulant Sodium Citrate Solution was shipped to one U.S. institutional customer for use in automated apheresis procedures—not to individual patients or retail pharmacies.

Can I filter Baxter Anticoagulant Sodium Citrate Solution to remove the fiberglass?

Baxter advises against filtering and using the product. All Baxter Anticoagulant Sodium Citrate Solution from lot Y493475 must be returned, regardless of filtration capability.

Will Baxter provide credit or replacement for returned Anticoagulant Sodium Citrate Solution?

Yes. Baxter is coordinating directly with the impacted customer to arrange product return, credit, or replacement for the affected Baxter Anticoagulant Sodium Citrate Solution lot.

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