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Open, Classified

Autoject EI, REF AJ1310

FDA Recall Z-0263-2020 · Posted None

Recalling FirmOwen Mumford USA, Inc.
Recall StatusOpen, Classified
Product CodeKZH
Date Initiated2019-07-17
Product Quantity1510 units

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

Firm 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.

Root Cause

Employee error

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945660AUTOJECT 2Owen Mumford USA, Inc. · 1995-08-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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