American College of Cardiology Foundation

12/02/2019 | Press release | Distributed by Public on 12/02/2019 16:18

FDA Update: Blood Administration Sets Recalled Due to Potential For Leakage

On Nov. 27, B. Braun Medical initiated a voluntary recall of 22 lots of Blood Administration Sets, 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, due to potential for leakage at the joint between the blood filters and tubing.

Blood set leakage may result in the potential for microorganisms to enter the circulatory system creating a risk of bloodstream infection or delay in therapy due to the need to replace the set and blood product. To date, there have been no reports of serious injury or death.

Read the full U.S. Food and Drug Administration announcement and how to report adverse events or side effects here.

Keywords:ACC Advocacy, Medical Device Recalls, United States Food and Drug Administration

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