The U.S. Food and Drug Administration (FDA) is aware that B Braun Medical, Inc. has identified a manufacturing issue where the arterial and venous patient connectors of certain lots of Streamline Bloodline Set for Dialog+ were damaged which may result in micro-air bubbles in the line and trigger air-in-line alarms. This damage creates a pathway for air to enter the extracorporeal circuit and the potential for blood/fluid leakage.
The detection of micro-air bubbles in the line during patient use may require set replacement, resulting in treatment delays, or inadequate or inefficient treatment. In cases where air is pulled into the line, blood in the extracorporeal circuit cannot be returned to the patient and must be discarded, leading to moderate patient blood loss. In some instances, this blood loss may cause a significant change in patient condition requiring immediate treatment. An opening in the bloodline results in a loss of sterility, potentially leading to bloodstream infections that require medical intervention. In some patients, including critically ill patients, blood loss or potential infection may lead to life-threatening adverse events, including death. Additional risks include air entering the patient circulation, which may lead to air embolism.
As of September 30, 2025, BBMI has received no reports of serious injuries or deaths associated with this issue.
This recall involves updating instructions for using certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact BBMI’s Postmarket Surveillance Department at 1-833-425-1464.
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