Drug recall
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and…
FDA recall event 85403 · Class II · Genicon, Inc.
Key facts
| Event ID | 85403 |
|---|---|
| Recall numbers | Z-2005-2020 |
| Recalling firm | Genicon, Inc. |
| Product type | Devices |
| 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. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval. |
| Initiation date | Jun 27, 2018 |
| Report date | May 20, 2020 |
| City | Winter Park |
| State | FL |
| Country | United States |
| FEI number | 3002590791 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: