FDA recall Z-2005-2020

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.

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2018-06-27

Report date

2020-05-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Winter Park, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2005-2020