Data Foundry

Medical device recalls 2024

STREAMLINE BLOODLINE LONG VERSION — Class II medical device recall Z-3176-2024

Ongoing recall by B Braun Medical Inc, reported 2024-09-25, distributed nationwide. Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the L

Recall numberZ-3176-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmB Braun Medical Inc, Bethlehem, PA, United States
Recall initiated2024-08-15
Classified2024-09-19
Reported by FDA2024-09-25
DistributedNationwide (US)
Quantity2,021,376 units
Reason classesdevice malfunction
UPC / GTIN / UDI-DI04046955348909
Model numbersSL-2000M2095L

Product

STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095L

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3176-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.