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Genicon, Inc. recalls Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized
Recalled May 20, 2020 · FDA recall Z-2005-2020 · Genicon
Hazard
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval. · FDA Class II
Units
1550
Sold at
Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.
Description
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
Product
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.
Manufacturer(s)
Genicon, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →