FDAFDA · Food and drugs·Recall number Z-2005-2020
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.
Published May 20, 2020 · Recall initiated: June 27, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Genicon, Inc.
- Distributor
- Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.
- Lot
- Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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