The Recall Desk
HighFDA (Devices)·Z-3177-2024·Announced 2024-09-25

Hemodialysis tubing connector may not fully insert, risking flow occlusion

B. Braun Medical is recalling STREAMLINE LONG hemodialysis bloodline tubing because the patient connector may fail to fully insert into the Locksite, potentially causing blood flow obstruction during dialysis treatment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device with potential for flow occlusion during critical hemodialysis procedures. While no injuries have been reported, the defect affects a life-sustaining medical device where incomplete connector insertion poses risk of therapy disruption.

Plain-English summary

B. Braun Medical is recalling STREAMLINE LONG hemodialysis bloodline tubing (Model SL-2000M2095W, UDI-DI 04046955348800, all unexpired lots) used to transfer blood between patients and hemodialyzers during dialysis treatment. Approximately 142,336 units have been distributed nationwide in the United States.

The patient connector may not fully insert into the Locksite. When the connector is not completely inserted, the internal septum may not open fully enough to prevent restrictions to blood flow. This incomplete insertion could result in occlusion or restricted flow during dialysis procedures.

When incomplete insertion occurs, the obstruction may cause therapy delays and force clinicians to switch from the prograde rinseback method to retrograde flow methods. Healthcare providers using this product should contact B. Braun Medical Inc. for guidance on the recall and appropriate corrective actions.

The recalled product

Product
STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W
Manufacturer
B Braun Medical Inc
Category
Medical Device — Hemodialysis / Bloodline Transfer Tubing
Hazard
Affected units
142,336

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI-DI 04046955348800
  • All Unexpired Lot Numbers

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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