What happened
On August 25, 2026, Baxter International announced a voluntary nationwide recall of one lot of Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container, because of potential particulate matter identified as fiberglass. The affected lot is Y493475, product code 2B7867Q, NDC 0338-9669-01, expiring December 31, 2027. It was distributed July 2-11, 2026, to one U.S. customer. Baxter instructed the customer to discontinue use immediately and return affected units. The product is intended for automated apheresis devices and is not for direct intravenous infusion. Baxter reported no related adverse events as of August 25, 2026, and FDA was notified.
Why it matters
From a GMP and manufacturing perspective, the potential presence of fiberglass particulate matter may matter to contamination control, investigation of foreign material, and recall execution. The announcement states that, without in-line filtration, particles may cause vein irritation, inflammatory or hypersensitivity reactions, or systemic embolization resulting in tissue or organ injury. Identification by lot number and expiration date supports targeted segregation and return; the source does not describe the particulate source or corrective actions.
Key topics: Fiberglass particulate matter in sodium citrate solution, Recall of lot Y493475, Discontinuation and return of affected units