Recall Z-2005-2020— Genicon, Inc.
Class II · Ongoing
Class II FDA medical device recall by Genicon, Inc., initiated 2018-06-27. It names one FDA 510(k) clearance: K180579. 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: Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval..
- Recalling firm
- Genicon, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-06-27
- Firm location
- Winter Park, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.