Home/Recalls/FDA-Z-1798-2026
FDA DevicesClass I

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Mode...

Published: April 22, 2026Recall ID: Z-1798-2026Category: devicesCountry: US

Reason for Recall / Hazard

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Product Description & Identification

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

Affected Products

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

Additional Source Details

FieldValue
CityBethlehem
StatePA
Event id98552
Address 1824 12th Ave
Address 2N/A
Code infoModel Number SL-2010M2096A; UDI-DI Primary: 04046955674992; UDI-DI Unit: 04046955735280; All lots manufactured since 09JUN2025
Postal code18018-3524
Report date20260422
Product typeDevices
Product quantity3,158,104 units
Reason for recallPotential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260319
Initial firm notificationLetter
Center classification date20260415

Overview

  • Recalling FirmB Braun Medical Inc
  • StatusOngoing
  • Risk LevelClass I
  • DistributionWorldwide distribution - US Nationwide and the country of Canada.
Official Agency Alert