Owen Mumford USA, Inc.
FDA Regulatory Profile
Owen Mumford USA, Inc. appears in FDA public data with 7 recalls, 10 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2078-2021, Class II) was initiated on May 26, 2021. Its most recent 510(k) clearance was granted on November 13, 2001.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 10
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2078-2021 | Class II | Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remove | May 26, 2021 |
| Z-0263-2020 | Class II | Autoject EI, REF AJ1310 | July 17, 2019 |
| Z-0264-2020 | Class II | Petfine Auto Injector, REF 3310VET | July 17, 2019 |
| Z-0382-2018 | Class II | Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, n | November 6, 2017 |
| Z-0381-2018 | Class II | Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, n | November 6, 2017 |
| Z-2082-2015 | Class II | Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 0847 | December 11, 2014 |
| Z-1366-2015 | Class II | Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an | November 24, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K013362 | AUTOJECT 2 | November 13, 2001 |
| K993385 | AUTOJET 2 (NON-FIXED NEEDLE TYPE) | November 10, 1999 |
| K983994 | UNIFINE | January 8, 1999 |
| K983974 | OWEN MUMFORD 3ML AUTOPEN | December 21, 1998 |
| K982275 | RAPPORT V.T.D. | December 4, 1998 |
| K983045 | AMIELLE | November 25, 1998 |
| K973899 | UNIFINE PENTIPS | December 4, 1997 |
| K971443 | RAPPORT V.T.D. | September 26, 1997 |
| K953735 | AUTOJECT MINI | November 8, 1995 |
| K945660 | AUTOJECT 2 | August 11, 1995 |