Intravascular Administration Set

• • Ongoing Z-2458-2021 FDA Class II ·initiated 2 Aug 2021

  Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

• • Terminated Z-2281-2013 FDA Class II ·initiated 30 Aug 2013

  CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.

510(k) Number

K820278 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Infusion Pump

  Class II

  FDA 510(k) K930781 Active Cleared 19 Aug 1993

• Model EZ-1 Sing CHAN/EZ-2 Dual Channel Infus Pump

  Class II

  FDA 510(k) K931549 Active Cleared 12 Oct 1993

• Ivac Syring Pump Model 770

  Class II

  FDA 510(k) K925091 Active Cleared 8 Jul 1993

• Model 2082 Temp Plus Iii Thermometer/Model 2087 Temp Plus Iii Wall Mount Thermometer

  Class II

  FDA 510(k) K955846 Active Cleared 1 Oct 1996

• Ivac Vented Syringe Adapter Administration Sets

  Class II

  FDA 510(k) K934095 Active Cleared 10 Aug 1994

• Ivac Needle Free Valve Administration Sets Open recall

  Class II

  FDA 510(k) K960280 Active Cleared 4 Apr 1996

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