Device recall
Z-2050-2017: Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1…
FDA device recall · Class II · Mederi Therapeutics, Inc
Key facts
| Recall number (Z-number) | Z-2050-2017 |
|---|---|
| Recall event | 76972 |
| Product | Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580 |
| Product code | GEI |
| Recalling firm | Mederi Therapeutics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 10, 2017 |
| 510(k) numbers | K152317 |
| FEI number | 3007729452 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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