Drug recall
EndoVive 3s Low Profile Balloon Kits Part Number: M00548220 (XMD P/N 70-0050-112) The EndoVive 3s Low Profile…
FDA recall event 73024 · Class II · Xeridiem Mediem Medical Devices Inc
Key facts
| Event ID | 73024 |
|---|---|
| Recall numbers | Z-0912-2016, Z-0913-2016, Z-0914-2016, Z-0915-2016, Z-0916-2016, Z-0917-2016, Z-0918-2016, Z-0919-2016, Z-0920-2016, Z-0921-2016, Z-0922-2016, Z-0923-2016 and 93 more |
| Recalling firm | Xeridiem Mediem Medical Devices Inc |
| Product type | Devices |
| Products | EndoVive 3s Low Profile Balloon Kits Part Number: M00548220 (XMD P/N 70-0050-112) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for…, EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-0050-212) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for…, EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-0050-312) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for…, EndoVive 3s Low Profile Balloon Kits Part Number: M00548250 (XMD P/N 70-0050-412) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for…, EndoVive 3s Low Profile Balloon Kits Part Number: M00548260 (XMD P/N 70-0050-512) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for… and 99 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus… |
| Initiation date | Dec 23, 2015 |
| Report date | Mar 2, 2016 |
| Termination date | Oct 25, 2016 |
| City | Tucson |
| State | AZ |
| Country | United States |
| FEI number | 2025851 |
At a glance
- 100–999 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: