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B. Braun Medical Inc. Issues Voluntary Nationwide Recall of twenty-two (22) lots of Blood Administration Sets, Due to Potential for Leakage at the Joint between the Blood Filters and Tubing

BETHLEHEM, PA – November 20, 2019 - 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.  

Product Catalog Number:

Lot Number

GUIDID

Product Description:

477005

61679395

04046955202799

Outlook® Safety Infusion System Y-type Blood Set

477005

61685454

04046955202799

Outlook® Safety Infusion System Y-type Blood Set

490293

61681734

04046964539657

Y-type Blood Set

490314

61674868

04046964527180

Y-type Blood Set

490314

61677175

04046964527180

Y-type Blood Set

490314

61678259

04046964527180

Y-type Blood Set

490314

61685087

04046964527180

Y-type Blood Set

490425

61674871

04046964813702

Y-type Blood Set

490425

61680607

04046964813702

Y-type Blood Set

490425

61685094

04046964813702

Y-type Blood Set

490530

61674878

04046955203321

Y-type Blood Set

490530

61677192

04046955203321

Y-type Blood Set

490530

61678186

04046955203321

Y-type Blood Set

490530

61681736

04046955203321

Y-type Blood Set

490530

61685105

04046955203321

Y-type Blood Set

NF5140

61681745

04046964187483

Safeline® Y-Type Blood Set

NF5140

61685109

04046964187483

Safeline®  Y-Type Blood Set

V2500

61674884

04046964188633

Y-Type Blood Set

V2500

61677634

04046964188633

Y-Type Blood Set

V2500

61678262

04046964188633

Y-Type Blood Set

V2500

61680625

04046964188633

Y-Type Blood Set

V2500

61685110

04046964188633

Y-Type Blood Set

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 nutrition, pharmacy admixture and dialysis. 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 64,000 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, explore our website.