Recall Z-0263-2020 ยท KZH Introducer, Syringe Needle
Owen Mumford USA, Inc.
Autoject EI, REF AJ1310
| Date | Jul 17, 2019 |
| Status | Open, Classified |
| 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 |
| Root cause | Employee error |
| Action | The firm initiated the recall by letter on 07/17/2019. The consignee was directed to quarantine all affected product and contact the company for return. Distributors were also directed to cease distribution and contact their customers. |
| Quantity | 1510 units |
| Distribution | FL, LA, SC, CA, NJ, TX, NC, CO, NH, KY, NY, MO, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945660 | AUTOJECT 2 Owen Mumford USA, Inc., Aug 11, 1995 |