B. Braun Medical Receives FDA Approval for 0.9% Sodium Chloride in Ecoflac™ Plus
Move aimed at alleviating IV saline shortage in the U.S.
ET | Source: B.Braun Medical Inc.–US
BETHLEHEM, Pa., Jan. 31, 2018 (GLOBE NEWSWIRE) — B. Braun Medical Inc., a leader in infusion therapy and pain management, announced today that it has received U.S. Food and Drug Administration (FDA) approval for 0.9% Sodium Chloride Injection, USP in the Ecoflac™ Plus 500 mL container. Over the past few years, B. Braun worked closely with the FDA to temporarily import Ecoflac Plus under regulatory discretion from the FDA inspected sterile injectable facility in Melsungen, Germany.
The addition of Ecoflac Plus expands B. Braun’s offering of intravenous solutions and provides an additional option to administer 0.9% Sodium Chloride, which B. Braun currently offers in its EXCEL® containers, E3® containers and PAB® Partial Additive Bags.
“B. Braun is committed to helping combat the IV saline shortage in the U.S.,” said Tom Sutton, Vice President of Marketing, Medical Device and Pharmaceutical Systems at B. Braun. “This approval allows us to offer a more consistent supply of 0.9% Sodium Chloride to the market.
“We continue to work with the FDA on additional opportunities to improve market supply of IV saline,” Sutton added.
The Ecoflac Plus container is produced from a medical grade polyethylene, which is not made with natural rubber latex, Di-ethylhexyl phthalate (DEHP) or Polyvinyl Chloride (PVC). B. Braun was the first medical device manufacturer to remove harmful PVC and DEHP from many of its products. To learn more about B. Braun’s commitment to protecting people and the environment while improving patient outcomes and reducing healthcare costs visit www.bbrauncares.com.
To learn more about the Ecoflac Plus, as well as B. Braun’s full drug delivery portfolio, call 1-800-227-2862.
About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 58,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs.
To learn more about B. Braun Medical, visit www.BBraunUSA.com.
B. Braun Medical Inc.