Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3177-2024 — STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W

U.S. FDA — Device Enforcement · United States · 2024-08-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3177-2024
Date of alert
2024-08-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
B Braun Medical Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04046955348800
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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