Needle-Pro Cartridge

• • Terminated Z-2670-2017 FDA Class II ·initiated 4 Apr 2017

  Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming inspection. The syringe assemblies were used to manufacture seven (7) finished good lots of Hypodermic Needle Pro needles, Smiths Medical part numbers EL 1915 and SB5021.

510(k) Number

K923127 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Suction Control Valve

  Class I

  FDA 510(k) K892343 Active Cleared 24 Apr 1989

• Accu-Vent(Tm) with Needle-Pro(Tm)

  Class I

  FDA 510(k) K912043 Active Cleared 5 Jul 1991

• Subcutaneous Tunneling Needle and Handles

  Class II

  FDA 510(k) K930218 Active Cleared 27 Jul 1993

• Heat Moisture Condenser

  Class I

  FDA 510(k) K923910 Active Cleared 26 Jan 1993

• Anesthesia Breathing Circuit

  Class I

  FDA 510(k) K915452 Active Cleared 14 Feb 1992

• New-Vent

  Class II

  FDA 510(k) K911809 Active Cleared 26 Aug 1991

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