Vented/Non-Vented Gemini Administration Set

• • Ongoing Z-2459-2021 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-1179-2016 FDA Class II ·initiated 15 Feb 2016

  CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.

• • Terminated Z-0445-2016 FDA Class II ·initiated 5 Nov 2015

  CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.

• • Terminated Z-2025-2014 FDA Class II ·initiated 17 Jun 2014

  CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip c

• • Terminated Z-0450-2014 FDA Class II ·initiated 8 Nov 2013

  CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.

• • Terminated Z-0435-2014 FDA Class II ·initiated 8 Nov 2013

  CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.

• • Terminated Z-2285-2013 FDA Class II ·initiated 30 Aug 2013

  CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.

510(k) Number

K944320 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• The Imed Ambulatory Infusion Pump, Administration Sets

  Class II

  FDA 510(k) K953896 Active Cleared 20 Mar 1996

• Macrodot Add-I-Med Admin. Set

  Class II

  FDA 510(k) K823347 Active Cleared 24 Nov 1982

• Imed Gemini 12 Nonvented Y-Type Blood/Solution Adm

  Class II

  FDA 510(k) K894842 Active Cleared 12 Sep 1989

• Imed(R) Gemini(Tm) Pc-1 Volumetric Infusion Pump

  Class II

  FDA 510(k) K880479 Active Cleared 25 Apr 1988

• IV Filterset 5 Micrometer

  Class II

  FDA 510(k) K813445 Active Cleared 5 Jan 1982

• Imed Accuset Cassette

  Class II

  FDA 510(k) K812035 Active Cleared 28 Jul 1981

See all devices from Imed Corp. →