Ivac(R) Unvented Vol. Infusion Set Model 52080

• • Ongoing Z-0350-2024 FDA Class II ·initiated 11 Oct 2023

  Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

• • Terminated Z-0832-2013 FDA Class II ·initiated 20 Dec 2012

  CareFusion is recalling the SmartSite Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.

510(k) Number

K882302 ↗

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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