B. Braun Removes Streamline Bloodline Set for Dialog+ Due to Leak Risks
The US FDA has issued an early alert regarding a recall initiated by B. Braun for specific lots of the Streamline Bloodline Set for Dialog+. The recall was prompted because a required solvent application step during assembly was omitted, leading to inadequate bonding of the dialyzer connector.
This defect can cause the bloodline connector to detach or leak during priming or hemodialysis treatment. Resulting complications may include blood loss, clotting and occlusion of the extracorporeal circuit, or air ingress into the blood circuit. B. Braun advises customers to inform all users, check inventories, cease use, quarantine affected products, and return them to the manufacturer.
Key points
- Affected product: Streamline Bloodline Set for Dialog+, Model SL-2010M2096.
- Impacted lots include A2600099, A2600128, and A2600136.
- Inadequate bonding of the dialyzer connector can cause leaks, detachment, blood loss, and air entry.
- B. Braun recommends quarantining and returning all affected devices.
What it means for you
Clinicians and healthcare personnel utilizing hemodialysis systems should verify their inventory against the affected model and lot numbers provided in the alert. If these specific lots are present, immediately cease their use, quarantine the items, and return them as advised by the manufacturer. Healthcare professionals in Pakistan should check with local suppliers or the Drug Regulatory Authority of Pakistan (DRAP) regarding the availability and safety status of affected batches locally.
Early Alert: B. Braun Removes Streamline Bloodline Set for Dialog+
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.