B. Braun voluntarily recalls one lot of Excel Lactated Ringers IV solution over particulate contamination

B. Braun Medical Inc announced a voluntary recall of a specific lot of its Excel Lactated Ringers Injection, a 1000 mL IV solution, after detecting particulate matter in the product.

Laboratory analysis identified the particles primarily as cellulose cotton fibers, with some cellulose wood fibers and traces of polystyrene. The presence of these foreign materials raises safety concerns.

The company warned that infusion of the contaminated solution could cause pulmonary emboli, vessel occlusions, tissue damage, or phlebitis, and may trigger systemic immune reactions, organ dysfunction, or hemolysis. No adverse events have been reported to date.

The recall is limited to the affected lot and is being directed to hospitals and healthcare facilities for removal from inventory. B. Braun is cooperating with the FDA and has not indicated any further impact on other product lines.