B BRAUN MEDICAL recalled 1,298,454 STREAMLINE BLOODLINE SET FOR DIALOG devices nationwide in the United States after observations of micro-air bubbles and air-in-line alarms linked to damaged arterial and venous connectors. The defect increases the risk of air entering the bloodstream during dialysis. Patients and healthcare providers should stop using this device immediately and follow the recall
The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B BRAUN MEDICAL INC or your healthcare provider for instructions. Notification method: Letter
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Hemodialysis bloodlines connect a dialysis machine to a patient to filter blood. They are critical components in dialysis therapy.
Damaged arterial and venous connectors can allow micro-air bubbles to enter the bloodstream. This can trigger air embolism risks and may trigger alarms to fail to protect the patient.
This recall is not described as part of a broader industry pattern.
Hospitals and dialysis centers may need to halt use of affected lots and arrange replacements. The recall could affect patient safety and care continuity, with financial and operational implications for facilities.
Look on the device label for the model, UDI, and lot number. Official recall notices provide instructions and replacement options.
Manufacturers typically issue replacements or other remedies within 4-8 weeks after recall initiation.
Keep copy of recall notice, serial numbers, UDI, lot numbers, and all correspondence with the manufacturer.
Brand: B BRAUN MEDICAL Product: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 UDI-DI: 04046964367786 Lot Numbers: A2500119, A2500121, A2500128, A2500129, A2500130, A2500132, A2500133, A2500134, A2500149, A2500150, A2500151, A2500180, A2500181, A2500182, A2500185, A2500198, A2500199, A2500200 Quantity: 1,298,454 units Distribution: US Nationwide Distribution Sold From/To: Unknown Recall Date: 2025-09-30 Status: ACTIVE Price: Unknown Country of Origin: Unknown
No injuries or incidents have been reported.
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