Device recall
Z-2122-2016: Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection…
FDA device recall · Class II · Covidien, LLC
Key facts
| Recall number (Z-number) | Z-2122-2016 |
|---|---|
| Recall event | 74300 |
| Product | Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device… |
| Product code | EOX |
| Recalling firm | Covidien, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 18, 2017 |
| 510(k) numbers | K152794 |
| FEI number | 3004904811 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database