Low Volume Multiport

• 9 recalls, same reason

  • Ongoing Z-0678-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0617-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0637-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0629-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0686-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0705-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0610-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0636-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0655-2026 FDA Class II ·initiated 29 Oct 2025

  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

• • Ongoing Z-3144-2024 FDA Class II ·initiated 8 Aug 2024

  Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.

• • Terminated Z-0933-03 FDA Unclassified (pre-2012) ·initiated 14 Apr 2003

  possible leakage

510(k) Number

K943770 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Trumpet Valve

  Class II

  FDA 510(k) K911415 Active Cleared 3 Jun 1991

• Comfort-Q Subcutaneous Injection Sets

  Class II

  FDA 510(k) K946170 Active Cleared 3 Nov 1995

• Dualtherm(R) Cardiac Output Computer

  Class II

  FDA 510(k) K925285 Active Cleared 21 Jul 1993

• Charged Supor(R) Filter Extension Set

  Class II

  FDA 510(k) K940980 Active Cleared 14 Jul 1994

• Celsite Brachial Venous Port

  Class II

  FDA 510(k) K945752 Active Cleared 31 May 1995

• Celsite(Tm) Dual Venous System

  Class II

  FDA 510(k) K945551 Active Cleared 21 Apr 1995

See all devices from B. Braun of America, Inc. →