Owen Mumford USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
10
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2078-2021Class IIUnifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle removeMay 26, 2021
Z-0263-2020Class IIAutoject EI, REF AJ1310July 17, 2019
Z-0264-2020Class IIPetfine Auto Injector, REF 3310VETJuly 17, 2019
Z-0381-2018Class IIUnifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, nNovember 6, 2017
Z-0382-2018Class IIUnifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, nNovember 6, 2017
Z-2082-2015Class IIAutopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 0847December 11, 2014
Z-1366-2015Class IIAutoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is anNovember 24, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K013362AUTOJECT 2November 13, 2001
K993385AUTOJET 2 (NON-FIXED NEEDLE TYPE)November 10, 1999
K983994UNIFINEJanuary 8, 1999
K983974OWEN MUMFORD 3ML AUTOPENDecember 21, 1998
K982275RAPPORT V.T.D.December 4, 1998
K983045AMIELLENovember 25, 1998
K973899UNIFINE PENTIPSDecember 4, 1997
K971443RAPPORT V.T.D.September 26, 1997
K953735AUTOJECT MININovember 8, 1995
K945660AUTOJECT 2August 11, 1995