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Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is...

FDA Recall #Z-1366-2015 — Class II — November 24, 2014

Recall #Z-1366-2015 Date: November 24, 2014 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

The syringe carrier is missing components: a damper and spring.

Recalling Firm

Owen Mumford USA, Inc. — Marietta, GA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3,100

Distribution

US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX.

Code Information

Lot No. 5LW

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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