TOPIC: One Lot of Anticoagulant Sodium Citrate Solution by Baxter: Recall - Due to Potential Presence of Particulate Matter
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Cardiology, Hematology
ISSUE: Baxter is 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.
The impacted product was distributed from 7/2/2026 to 7/11/2026 to one customer in the United States.
As of 8/25/2026, Baxter has not received any reports of adverse events related to this issue.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled 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.
RECOMMENDATIONS:
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Consumers 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.
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For general questions regarding this communication, please contact Baxter Healthcare Center for Service at 888-229-0001.
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