Agency classClass IIOur severity:High FDA (Devices)·Z-3174-2024·Announced 2024-09-25

Hemodialysis tubing may fail to flow if connector is incompletely inserted

B Braun's STREAMLINE FRESENIUS bloodline tubing used in hemodialysis may have a design issue where incomplete insertion of the patient connector prevents proper blood flow during certain procedures. Patients receiving dialysis may experience treatment delays.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 used in life-sustaining hemodialysis therapy with a design flaw that could restrict critical blood flow. The hazard (incomplete connector insertion leading to occlusion) qualifies as a risk-of-harm product scenario per the rubric, supporting a High (3) severity rating.

Plain-English summary

B Braun Medical Inc is recalling STREAMLINE FRESENIUS FOR DAVITA hemodialysis bloodline tubing (Model SL-2000M2095D) due to a design issue with the patient connector. If the connector is not fully inserted into the Locksite, the internal septum may not open completely, potentially restricting blood flow during prograde rinseback procedures.

4,671,540 units of this tubing have been distributed nationwide. The incomplete insertion may cause delays in hemodialysis therapy because clinicians may need to switch to alternative retrograde flow methods.

Patients using this tubing should contact their dialysis center to verify whether their units are affected. Healthcare facilities should check their inventory against the relevant lot numbers (all unexpired lots, UDI-DI 04046955348763).

The recalled product

Product: STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095D
Manufacturer: B Braun Medical Inc
Category: Medical Device — Hemodialysis Equipment
Hazard: occlusion
incomplete-insertion
Affected units: 4,671,540

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 04046955348763
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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Same hazard · occlusion