Z-0263-2020Class II

Autoject EI, REF AJ1310

Name: Z-0263-2020 Autoject EI, REF AJ1310
Creator: Owen Mumford USA, Inc.
Published: 2019-07-17
License: https://open.fda.gov/license/

Owen Mumford USA, Inc. / initiated 2019-07-17 / Open, Classified / root cause: manufacturing process

FDA source

Owen Mumford USA, Inc. began a recall of Autoject EI, REF AJ1310 on 2019-07-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0263-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-07-17
Posted: 2019-11-01
Recalling firm: Owen Mumford USA, Inc.
Product: Autoject EI, REF AJ1310
Product code: KZH Introducer, Syringe Needle
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
Root cause tag: manufacturing process
FDA 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 in commerce: 1510 units
Distribution: FL, LA, SC, CA, NJ, TX, NC, CO, NH, KY, NY, MO, PA
Product codes and lots: Lot/Unit Number: V14

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0263-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0263-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-13	2019-11-01
Z-0264-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-13	2019-11-01

Product code KZH

K945660Class IIAutoject 2Owen Mumford USA, Inc. / cleared 1995-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)