Genicon, Inc. recalls Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilize…

Recall date

June 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2005-2020

FDA classification

Class II

Brand / firm

Genicon, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.

Why it was recalled

Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.