Marietta, GA, United States
Owen Mumford USA, Inc. recalls
3 recalls recorded since 2018, most recently on 26 May 2021. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 May 2021
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2078-2021
- Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
Ongoing Class II Medical devices
- Recall started
- 17 July 2019
- Reason
- 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
- Distribution
- FL, LA, SC, CA, NJ, TX, NC, CO, NH, KY, NY, MO, PA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0263-2020, Z-0264-2020
- Autoject EI, REF AJ1310
- Petfine Auto Injector, REF 3310VET
Terminated Class II Medical devices
- Recall started
- 6 November 2017
- Terminated
- 12 February 2021
- Reason
- 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.
- Distribution
- US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH NJ, NY, OH, OK, PA, TN, NX, UT, VA, VT, WA, WV
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0381-2018, Z-0382-2018
- Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
- Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.