B Braun Medical Inc: Device Recall

Recall Details

Recall Number

Z-3176-2024

Classification

Class II

Product Type

Device

Recalling Firm

B Braun Medical Inc

Status

Ongoing

Date Initiated

08/15/2024

Location

Bethlehem, PA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

2021376 units

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

Product Description

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

Distribution Pattern

US Nationwide distribution.

Other Recalls by B Braun Medical Inc

• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

View all recalls by B Braun Medical Inc →