FDA-Device2020-05-20Class II
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.
Genicon, Inc.
Hazard
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.
Affected count
1550
Manufactured in
6869 Stapoint Ct Ste 112, N/A, Winter Park, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2005-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief