PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: September 25, 2024 Initiated: August 15, 2024 #Z-3178-2024

Product Description

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

Reason for Recall

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

Details

Recalling Firm
B Braun Medical Inc
Units Affected
9864165 units
Distribution
US Nationwide distribution.
Location
Bethlehem, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by B Braun Medical Inc. Units affected: 9864165 units.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Devices on September 25, 2024. Severity: Moderate. Recall number: Z-3178-2024.