FDA-Device2024-09-25Class II
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
B Braun Medical Inc
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
Sold states
US Nationwide distribution.
Affected count
9864165 units
Manufactured in
824 12th Ave, Bethlehem, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3178-2024Don't want to check this manually?
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