FDA issues early alert on B. Braun Streamline Bloodline Set recall due to connector leak risk
The FDA's Center for Devices and Radiological Health issued an Early Alert about B. Braun's Streamline Bloodline Set for Dialog+ after discovering a potential high risk issue.
The problem is traced to a missed solvent application step during assembly, which can leave the dialyzer connector insufficiently bonded. If the connector detaches, the bloodline may leak and cause blood loss. Affected lots include A2600099, A2600128 and A2600136.
B. Braun sent a letter to customers on Oct 20, 2026 advising them to inform all users, stop using and quarantine the affected devices, and return them to the manufacturer. The FDA will continue to monitor the situation and post updates.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Early Alert: B. Braun Removes Streamline Bloodline Set for Dialog+”
read at fda medwatch ↗
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