HIGHFDA DEVICE

B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

B Braun MedicalHealth & Personal CareMedical DevicesModel Number: SL-2000M2095DAUDI-DI Primary: 04046955776023UDI-DI Unit: 04046955776016

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
March 19, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
March 19, 2026
Hazard Level
HIGH
Brand
B Braun Medical
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
B Braun Medical
Model numbers
Model Number: SL-2000M2095DA, UDI-DI Primary: 04046955776023, UDI-DI Unit: 04046955776016, All lots manufactured since 09JUN2025.
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 19, 2026

  2. Reported by FDA DEVICE

    April 22, 2026

  3. RecallRadar source check

    April 29, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter

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Full Description

B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.. Reason: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.. Classification: Class I. Quantity: 1,174,271 units. Distribution: Worldwide distribution - US Nationwide and the country of Canada.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Model Number: SL-2000M2095DA
UDI-DI Primary: 04046955776023
UDI-DI Unit: 04046955776016
All lots manufactured since 09JUN2025.
Affected States
ALL
Report Date
April 22, 2026
Recall Status
ACTIVE

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