I.V. Administration Set with Mini-Spike

• 2 recalls, same reason

  • Ongoing Z-0129-2024 FDA Class II ·initiated 26 Sep 2023
  • Ongoing Z-0128-2024 FDA Class II ·initiated 26 Sep 2023

  Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

510(k) Number

K780551 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Root Canal Filling Applicator Needles

  Class I

  FDA 510(k) K801484 Active Cleared 21 Jul 1980

• Hydron Burn Dressing Field Kit

  Class I

  FDA 510(k) K791865 Active Cleared 16 Nov 1979

• Mark IV Syringe

  Class I

  FDA 510(k) K801483 Active Cleared 21 Jul 1980

• Zeon Composite Resin Light Cure Sys

  Class II

  FDA 510(k) K820028 Active Cleared 11 Mar 1982

• Zeon Composite Resin System

  Class II

  FDA 510(k) K820006 Active Cleared 22 Jan 1982

• IV Administration Set with Backcheck Open recall

  Class II

  FDA 510(k) K790062 Active Cleared 10 Apr 1979

See all devices from National Patent Development Corp. →