Owen Mumford USA, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1000219614
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 71 ongoing since 2021 (3 open in total)
What Owen Mumford USA, Inc. makes
Owen Mumford USA, Inc. manufactures single-use, pre-filled injection devices, including auto-injectors like the AUTOJECT 2 and AUTOJECT MINI, as well as pen-style injectors such as the RAPPORT V.T.D. and AMIELLE. Their portfolio also includes fixed and non-fixed needle auto-injectors, such as the AUTOJET 2, and insulin delivery devices like the UNIFINE. These products are designed for subcutaneous and intramuscular administration of medications.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Their products are intended for use in the United States, where regulatory compliance is required for market authorisation. No additional registries or international listings are specified.
Catalogue
Autoject 2 Ref K945660
Regimes: 510(k) Registry: 510(k)Unifine Pentips Ref K973899
Regimes: 510(k) Registry: 510(k)Autoject 2 Ref K013362
Regimes: 510(k) Registry: 510(k)Rapport V.T.D. Ref K971443
Regimes: 510(k) Registry: 510(k)Owen Mumford 3ml Autopen Ref K983974
Regimes: 510(k) Registry: 510(k)Rapport V.T.D. Ref K982275
Regimes: 510(k) Registry: 510(k)Amielle Ref K983045
Regimes: 510(k) Registry: 510(k)Autoject Mini Ref K953735
Regimes: 510(k) Registry: 510(k)Unifine Ref K983994
Regimes: 510(k) Registry: 510(k)Autojet 2 (Non-Fixed Needle Type) Ref K993385
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000219614
- Address
- 1755 W Oak Commons Ct, MARIETTA, GA, 30062
FDA recalls
FDA recall records list 7 recalls initiated by OWEN MUMFORD USA, INC., the earliest on 2014-11-24 and the most recent on 2021-05-26. By recorded status: 3 ongoing and 4 terminated. The reasons filed fall into these groups: sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 2
- 2018 0
- 2019 2
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 26 May 2021 Z-2078-2021 Class II Ongoing Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.
Full distribution text
- 26 May 2021 Z-2078-2021 Class II Ongoing Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.
2019
- 17 Jul 2019 Z-0263-2020 Class II Open since 2019 There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107
- 17 Jul 2019 Z-0264-2020 Class II Open since 2019 There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107
2017
- 6 Nov 2017 Z-0381-2018 Class II Terminated Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
Full distribution text
- 6 Nov 2017 Z-0382-2018 Class II Terminated Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
Full distribution text
- 6 Nov 2017 Z-0381-2018 Class II Terminated Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
2014
- 11 Dec 2014 Z-2082-2015 Class II Terminated The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection.
- 24 Nov 2014 Z-1366-2015 Class II Terminated The syringe carrier is missing components: a damper and spring.
Frequently asked questions
How many devices does OWEN MUMFORD USA, INC. have in the registry?
The registry currently lists 10 devices for OWEN MUMFORD USA, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list OWEN MUMFORD USA, INC.'s devices?
Among its 10 most recently registered devices, OWEN MUMFORD USA, INC. has devices listed in FDA 510(k) (10 devices).
What risk classes do OWEN MUMFORD USA, INC.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for OWEN MUMFORD USA, INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for OWEN MUMFORD USA, INC.?
FDA recall records list 7 recalls initiated by OWEN MUMFORD USA, INC., the most recent initiated on 26 May 2021. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from OWEN MUMFORD USA, INC. in the registry?
The most recently registered devices listed for OWEN MUMFORD USA, INC. include AUTOJECT 2, UNIFINE PENTIPS, RAPPORT V.T.D. and OWEN MUMFORD 3ML AUTOPEN.