B Braun Medical Inc recalls STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemod…

Recall date

August 15, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3174-2024

FDA classification

Class II

Brand / firm

B Braun Medical Inc

Sold / distributed

US Nationwide distribution.

Why it was recalled

Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095D