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FDAFDA · Food and drugs·Recall number Z-3178-2024

STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096

Published September 25, 2024 · Recall initiated: August 15, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
B Braun Medical Inc
Distributor
US Nationwide distribution.
Lot
UDI-DI 04046964367786; All Unexpired Lot Numbers
Risk classification
Class II
Area (FDA)
device
Country
United States

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