Portex Hypodermic Needle-Pro Fixed Needle Syringe

• • Terminated Z-1798-2021 FDA Class I ·initiated 17 May 2021

  Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.

• 5 recalls, same reason

  • Terminated Z-0643-2014 FDA Class II ·initiated 10 Jul 2013
  • Terminated Z-0644-2014 FDA Class II ·initiated 10 Jul 2013
  • Terminated Z-0646-2014 FDA Class II ·initiated 10 Jul 2013
  • Terminated Z-0642-2014 FDA Class II ·initiated 10 Jul 2013
  • Terminated Z-0645-2014 FDA Class II ·initiated 10 Jul 2013

  Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes

510(k) Number

K063755 ↗

FDA Product Code

MEG

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

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• EchoGlo Needle

  Class II

  FDA 510(k) K171968 Active Cleared 25 Jan 2018

See all devices from Smiths Medical Asd, Inc. →