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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

B Braun Medical Inc: Streamline Hemodialysis Bloodlines Recalled for Potential Blood Flow Blockage

Agency Publication Date: September 19, 2024
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Summary

B Braun Medical Inc. is recalling approximately 43.6 million units of Streamline Airless System Hemodialysis Bloodlines across seven different models used in dialysis treatments. The recall was initiated because the patient connector may not fully insert into the 'Locksite' port, which can prevent the internal valve from opening completely. This defect can block the flow of blood during cleaning procedures, potentially causing therapy delays or forcing medical staff to switch to alternative flow methods. This recall affects all unexpired lots of the listed Streamline models distributed nationwide.

Risk

If the patient connector is not fully inserted, the internal seal may restrict or block blood flow during the rinseback process. This can lead to significant delays in vital hemodialysis therapy while clinicians are forced to troubleshoot the equipment or switch to a retrograde flow method.

What You Should Do

  1. Identify if your facility is using the affected Streamline Bloodlines by checking for the following Model/Catalog Numbers: SL-2000M2095, SL-2000M2095D, SL-2000M2095DA, SL-2000M2095L, SL-2000M2095W, SL-2010M2096, or SL-2010M2096A.
  2. Verify the UDI-DI codes on the product packaging: 04046964367762, 04046955348763, 04046955776023, 04046955348909, 04046955348800, 04046964367786, or 04046955674992.
  3. Check the lot numbers on your inventory; this recall includes all unexpired lot numbers for the listed models.
  4. If you are a patient, contact your healthcare provider immediately to discuss your dialysis treatment and ensure your equipment is safe for use.
  5. Healthcare facilities should contact B Braun Medical Inc. at 824 12th Ave, Bethlehem, PA for specific instructions regarding the affected bloodlines.
  6. Contact the FDA for further information or to report adverse events at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Manufacturer consultation and therapy adjustment

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: SL BLOODLINE FOR FMC 2008 SERIES
Model / REF:
SL-2000M2095
Lot Numbers:
All Unexpired Lot Numbers
Product: STREAMLINE FRESENIUS FOR DAVITA
Model / REF:
SL-2000M2095D
Lot Numbers:
All Unexpired Lot Numbers
Product: STREAMLINE FRESENIUS FOR DAVITA
Model / REF:
SL-2000M2095DA
Lot Numbers:
All Unexpired Lot Numbers
Product: STREAMLINE BLOODLINE LONG VERSION, FMC
Model / REF:
SL-2000M2095L
Lot Numbers:
All Unexpired Lot Numbers
Product: STREAMLINE LONG
Model / REF:
SL-2000M2095W
Lot Numbers:
All Unexpired Lot Numbers
Product: STREAMLINE BLOODLINE SET FOR DIALOG
Model / REF:
SL-2010M2096
Lot Numbers:
All Unexpired Lot Numbers
Product: STREAMLINE BLOODLINE SET FOR DIALOG DR
Model / REF:
SL-2010M2096A
Lot Numbers:
All Unexpired Lot Numbers

Product Images

“Label, 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers”

“Label, 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95171
Status: Active
Manufacturer: B Braun Medical Inc
Sold By: B Braun Medical Inc; Direct distribution to hospitals and dialysis centers
Manufactured In: United States
Units Affected: 7 products (10658351 units; 4671540 units; 4984920 units; 2021376 units; 142336 units; 9864165 units; 11262112 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.