Device product
STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A
Z-3179-2024
Product summary
- Event
- Event 95171
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11262112 units
- Official record key
device-enforcement:Z-3179-2024
Official wording
Reason: 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
Code information: UDI-DI 04046955674992; All Unexpired Lot Numbers
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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