Ez-Io Intraosseous Infusion System

• 3 recalls, same reason

  • Ongoing Z-0689-2020 FDA Class II ·initiated 8 Oct 2019
  • Ongoing Z-0688-2020 FDA Class II ·initiated 8 Oct 2019
  • Ongoing Z-0690-2020 FDA Class II ·initiated 8 Oct 2019

  The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.

510(k) Number

K141117 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Ez-Connect

  Class II

  FDA 510(k) K061771 Active Cleared 10 Jul 2006

• The OnControl Bone Marrow Biopsy System by Vidacare

  Class II

  FDA 510(k) K142377 Active Cleared 17 Dec 2014

• The T.A.L.O.N. Intraossous Infusion System by Vidacre

  Class II

  FDA 510(k) K120661 Active Cleared 3 Jun 2012

• Powered Pd-Io Intraosseous Infusion System

  Class II

  FDA 510(k) K051992 Active Cleared 20 Oct 2005

• Vidaport Intraosseous Infusion System

  Class II

  FDA 510(k) K032885 Active Cleared 10 Mar 2004

• Pd-Io Disposable Intraosseous Infusion Needle

  Class II

  FDA 510(k) K043490 Active Cleared 18 Feb 2005

See all devices from Vidacare Corporation →