Home / Recalls / Owen Mumford USA, Inc. / Z-0264-2020

Z-0264-2020 Class II Ongoing

Recalled by Owen Mumford USA, Inc. — Marietta, GA

FDA device recall Z-0264-2020 was initiated by Owen Mumford USA, Inc. on July 17, 2019 and is designated Class II. Reason for recall: 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 &… The recall status is ongoing. Affected quantity: 140 units.

Recall Details

Product Type
Devices
Report Date
November 13, 2019
Initiation Date
July 17, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
140 units

Product Description

Petfine Auto Injector, REF 3310VET

Reason for Recall

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 Pattern

FL, LA, SC, CA, NJ, TX, NC, CO, NH, KY, NY, MO, PA

Code Information

batches V14.V976 and V14.W107

Other recalls by Owen Mumford USA, Inc.

  • Z-2078-2021 Class II — Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built (May 26, 2021)
  • Z-0263-2020 Class II — Autoject EI, REF AJ1310 (July 17, 2019)
  • Z-0381-2018 Class II — Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Produc (November 6, 2017)
  • Z-0382-2018 Class II — Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Produc (November 6, 2017)
  • Z-2082-2015 Class II — Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN380 (December 11, 2014)
  • Z-1366-2015 Class II — Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 T (November 24, 2014)

FDA data resources