The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3175-2024·Announced 2024-09-25

Hemodialysis bloodline tubing recalled for improper connector insertion risk

B. Braun is recalling approximately 4.98 million STREAMLINE FRESENIUS FOR DAVITA hemodialysis bloodline tubes due to risk of improper connector insertion, which could cause blood flow occlusion during dialysis treatment.

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: FDA Class II medical device recall involving a technical defect that could cause blood flow occlusion in hemodialysis treatment. No deaths, hospitalizations, or confirmed patient illnesses have been reported. This meets the High severity criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

B. Braun Medical Inc. is recalling approximately 4.98 million units of STREAMLINE FRESENIUS FOR DAVITA hemodialysis bloodline tubing (Model SL-2000M2095DA). The patient connector may not insert fully into the Locksite, which could prevent the internal septum from opening completely and restrict blood flow through the tubing.

If the patient connector is not fully seated in the Locksite, blood flow may become blocked during prograde rinseback procedures. This blockage may delay treatment and force clinicians to switch to retrograde flow methods to continue the dialysis session.

The recalled tubing was distributed nationwide across the United States. All unexpired lot numbers of this model are affected.

Patients and healthcare providers should ensure the patient connector is fully inserted into the Locksite before use. Healthcare facilities should verify proper insertion procedures and contact B. Braun Medical Inc. or the FDA for instructions on returning or replacing recalled units.

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-2000M2095DA
Manufacturer
B Braun Medical Inc
Category
Medical Device — Hemodialysis / Bloodline Tubing
Hazard
Affected units
4,984,920

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 04046955776023
  • 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 →

Related recalls

Same manufacturer · B Braun Medical Inc

See all →

Same hazard · blood flow occlusion

See all →

Similar recalls