Company Announcement Date: November 15, 2019

FDA Publish Date: November 26, 2019

Product Type: Medical Devices

Reason for Announcement: Potential leakage at joint between blood filter and tubing

Company Name: B. Braun Medical, Inc.

Brand Name: B. Braun

Product Description: Blood Administration Kits

B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. The recalled blood administration sets are used to administer blood from a container to a patient's vascular system through an IV catheter inserted into a vein or central venous catheter.

B. Braun identified through complaints and internal discrepancies the potential for leakage at the joint between the blood filters and tubing of these blood administration sets. Blood set leakage may result in delay in therapy due to the need to replace the set and blood product or result in the potential for microorganisms to enter the circulatory system creating a risk of bloodstream infection. To date there have been no reports of serious injury or death.

A total of 43,026 units of the recalled blood administration sets were manufactured between June 11, 2019 and August 23, 2019 and distributed between June 11, 2019 and September 27, 2019. B. Braun notified its distributors and customers by certified mail on November 20, 2019 and is arranging for the return of all recalled blood administration sets. Distributors and customers that have affected inventory should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 1-800-227-2862 Monday through Friday, 8 a.m. to 6 p.m. (EST) for instructions to return the affected blood administration sets; and to arrange for either replacement of product or refund. The recalled blood administration sets were distributed only to the United States and Canadian markets.

Consumers with questions regarding this recall, including arranging for replacement product or refund, can contact B. Braun Medical Inc.’s Customer Support Department at 1-800-227-2862 Monday through Friday, 8 a.m. to 6 p.m. (EST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

Adverse reactions or quality problems experienced with the use of this product should be reported to B. Braun’s Medical Information Department at 1-800-854-6851. Additionally, any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program:

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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. Other key product areas include ostomy and wound care, dialysis, nutrition, and pharmacy admixture. 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®.