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

Summary

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

Company Announcement

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
Product Catalog Number: Lot Number GUIDID Product Description:
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 useimmediately 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:

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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®.

Globally, the B. Braun Group of Companies employs more than 61,000 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.


Company Contact Information

Consumers:
B. Braun Medical Inc.’s Customer Support Department
1-800-227-2862
Media:
Allison Longenhagen
610-997-4768
Allison.Longenhagen@bbraunusa.com