Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.
FDA Recall Z-1366-2015 · Posted 2015-04-02
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Recalling FirmOwen Mumford USA, Inc.
Recall StatusTerminated
Product CodeKZH
Date Initiated2014-11-24
Date Terminated2017-07-31
Product Quantity3,100
Reason for Recall
The syringe carrier is missing components: a damper and spring.
Firm Action
Recall letters were issued to customers via FedEx. The letter instructed the customer to check their shelves for the product and specific lot number and to visually inspect (pictures included in letter of a correctly assembled device and one with the missing spring & damper) the device if they have the affected lot. A form was included which was to be filed out and returned.
Root Cause
Process control
Distribution Pattern
US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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