Recall Z-0263-2020— Owen Mumford USA, Inc.

Name: FDA recall Z-0263-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-17

Class II · Ongoing

Class II FDA medical device recall by Owen Mumford USA, Inc., initiated 2019-07-17. It names one FDA 510(k) clearance: K945660. Product: Autoject EI, REF AJ1310. 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.

Recalling firm: Owen Mumford USA, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-07-17
Firm location: Marietta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K945660 — AUTOJECT 2Owen Mumford USA, Inc.·cleared 1995-08-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Autoject EI, REF AJ1310

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.