- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
Recall Reason DescriptionPotential Leakage
- Company Name:
- B. Braun Medical Inc.
- Brand Name:
- Product Description:
Product DescriptionInfusion pump
B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of one lot of Infusomat ® Space Volumetric Infusion Pump Administration Sets (Catalog Number 363032, Lot Number 0061641410). The recalled administration sets are used to deliver parenteral fluids. B. Braun identified through customer complaints the potential of the infusion pump administration set to leak and/or disconnect at the bonded joint between the tubing and injection site. Leakage or disconnection of the set may result in the potential for microorganisms to contaminate the fluid path and enter the circulatory system, creating a risk of bloodstream infection. Additionally, if the fluid path is open, there is potential for air to enter the circulatory system, which might lead to air embolization. To date, we have received 17 complaints associated with the product. However, these complaints have not resulted in patient death or serious injury.
A total of 2,580 units of the recalled administration sets were manufactured on September 21, 2018 and distributed between November 23, 2018 and March 20, 2019. B. Braun notified its distributors and customers by certified mail on April 30, 2019 and is arranging for the return of all recalled administration sets. Distributors and customers that have inventory of Catalog Number 363032, Lot Number 0061641410, for Infusomat Space Volumetric Infusion Pump Administration Sets 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 administration sets; and to arrange for either replacement of product or refund. The recalled administration sets were distributed to one healthcare facility in the United States and one authorized distributor in Canada.
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
- B. Braun Medical Inc.’s Customer Support Department
- Allison Longenhagen