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FDA recall, , High risk

Baxter Anticoagulant Sodium Citrate Solution

Anticoagulant Sodium Citrate Solution may contain fiberglass particles that can cause adverse health consequences.

What happened

Baxter International Inc. is voluntarily recalling one lot of Anticoagulant Sodium Citrate 4% w/v Solution USP, 250 mL VIAFLEX Plastic Container due to the potential presence of particulate matter identified as fiberglass in the solution. Intravenous administration of a blood product treated with Anticoagulant Sodium Citrate containing particulate matter may lead to adverse health consequences.

The recall began August 19, 2026, and was announced August 25, 2026. The product was distributed in Ohio and Texas.

What to do

If a code on your package is listed below:

  1. The customer should immediately discontinue use of and return all affected units in accordance with their facility’s process.
  2. Baxter is contacting the customer by email with instructions on how to identify.
  3. Return the impacted product.
  4. 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.

Is yours affected?

Match the list below, then check the codes the FDA notice also names.

An NDC (National Drug Code) is usually printed on the drug's label.

  1. Anticoagulant Sodium Citrate 4% w/v Solution USP

    NDC
    • 0338-9669-01
    Lot code
    • Y493475

From the FDA notice

Anticoagulant Sodium Citrate 4% w/v Solution USP, 250 mL VIAFLEX Plastic Container Product Code 2B7867Q

Recall details

Company began the recall
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Company
Baxter Healthcare Corporation
Risk

High risk

There is a reasonable chance that taking it could cause serious health problems or death.

FDA Class I recall · How risk is rated

Event ID
99715
Recall number
B-0001-2027

All recalls from Baxter Healthcare Corporation

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Announced by the company

  3. Listed on Recall Canary

  4. Added to FDA's Enforcement Report

  5. Classified by FDA

  6. In FDA's weekly enforcement report

Summary by Recall Canary, written with AI · summary updated Oct 7, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)