Home / Recalls / B Braun Medical Inc / Z-1803-2026

Z-1803-2026 Class I Ongoing

Recalled by B Braun Medical Inc — Bethlehem, PA

Recall Details

Product Type
Devices
Report Date
April 22, 2026
Initiation Date
March 19, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,884 units

Product Description

B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

Reason for Recall

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Code Information

Model Number: B3-4630M4705; UDI-DI Primary: 04046955348848; UDI-DI Unit: 04046955348831; All lots manufactured since 05AUG2025.

Other recalls by B Braun Medical Inc

  • Z-1802-2026 Class I — B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model (March 19, 2026)
  • Z-1798-2026 Class I — B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Mode (March 19, 2026)
  • Z-1801-2026 Class I — B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model (March 19, 2026)
  • Z-1800-2026 Class I — B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: (March 19, 2026)
  • Z-1799-2026 Class I — B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Num (March 19, 2026)
  • Z-1481-2026 Class II — Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/ (February 2, 2026)
  • Z-1483-2026 Class II — Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7 (February 2, 2026)
  • Z-1482-2026 Class II — Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catal (February 2, 2026)
  • Z-0711-2026 Class II — SafeDAY set utilized in gravity IV administration sets and pump administration s (October 29, 2025)
  • Z-0675-2026 Class II — IV Administration Set utilized in gravity IV administration sets and pump admini (October 29, 2025)