CLASS II ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report
Streamline Bloodline Set For Dialog-Tubing to be used recalled
B Braun Medical is recalling Streamline Bloodline Set For Dialog-Tubing to be used to transfer blood between a patient, distributed nationwide in the US. The recall was initiated on 15 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3178-2024
- FDA event ID
- 95171
- Recalling firm
- B Braun Medical, Bethlehem, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Aug 2024
- FDA classified
- 19 Sep 2024
- Reported
- 25 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 15 Aug 2024 | Recall initiated by company | |
| 19 Sep 2024 | Classified by FDA | +35 days |
| 25 Sep 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Which lots are affected?
UDI-DI 04046964367786; All Unexpired Lot Numbers
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 95171This product is part of a recall event; the main page for the event is SL Bloodline For Fmc 2008 Series-Tubing to be used recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | SL Bloodline For Fmc 2008 Series-Tubing to be used recalled | B Braun Medical | Device Malfunction | Nationwide | |
| CLASS II | Streamline Fresenius For Davita-Tubing to be used recalled | B Braun Medical | Device Malfunction | Nationwide | |
| CLASS II | Streamline Fresenius For Davita-Tubing to be used recalled | B Braun Medical | Device Malfunction | Nationwide | |
| CLASS II | Streamline Long-Tubing to be used to transfer blood between recalled | B Braun Medical | Device Malfunction | Nationwide | |
| CLASS II | Streamline Bloodline Long recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide | |
| CLASS II | Streamline Bloodline Set For Dialog Dr-Tubing to be used recalled | B Braun Medical | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS I | Design Options Spinal Tray Spinal Needle Anesthesia recalled | B Braun Medical | Processing Deviation | Nationwide |
| Device | CLASS II | Sesk Upmc Double Catheter Tray recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |
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