Device recall
Z-0915-2016: EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N…
FDA device recall · Class II · Xeridiem Mediem Medical Devices Inc
Key facts
| Recall number (Z-number) | Z-0915-2016 |
|---|---|
| Recall event | 73024 |
| Product | EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N 70-0050-114) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile… |
| Product code | PIF |
| Recalling firm | Xeridiem Mediem Medical Devices Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2016 |
| 510(k) numbers | K142297 |
| FEI number | 2025851 |
At a glance
- 1–9 Linked 510(k)s
- 100–999 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