B. Braun Medical Inc. has announced a voluntary recall of two lots of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL due to the presence of particulate matter inside the containers. The recall is being conducted at the hospital level.
The company stated that it identified the issue through complaints indicating the potential for particulate matter in solution. According to B. Braun, there have been no reports of serious injury, death, or other adverse events linked to this problem so far.
“If the particulate matter is observed before use, a minor delay could occur while obtaining a replacement product. If the particulate matter is loose and the container is used on a patient, there is a potential for the particulate to be infused into the circulatory system. This could lead to patient harm that may require additional medical intervention and/or lead to permanent impairment or death,” B. Braun said in its announcement.
The company explained that using affected products carries risks such as pulmonary emboli, blood vessel occlusions which can result in tissue death or organ damage, and phlebitis, which may cause clotting. Systemic effects from foreign particles infused intravenously include immune system activation, organ dysfunction, and hemolysis.
The recalled products were distributed nationwide through various outlets including wholesale and retail channels.
B. Braun is notifying distributors and customers by certified mail with instructions for returning all recalled products. Distributors are advised to check their inventory, stop use and distribution of affected items, quarantine them, and not destroy any product subject to recall.
Customers with questions about the recall can contact B. Braun’s Recalls Department at 844-903-6417 between 9 AM and 5 PM EST. Consumers experiencing problems related to these products should consult their healthcare provider.
Adverse reactions or quality issues related to this product can be reported to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm or by downloading forms at www.fda.gov/MedWatch/getforms.htm.
“This recall is being conducted with the knowledge of the U.S. Food and Drug Administration,” according to B. Braun.
