FDA-Device2016-03-02Class II
EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)
Xeridiem Mediem Medical Devices Inc
Hazard
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 allowing feeding solution or gastric contents to leak out of the device in some instances.
Sold states
Nationwide distribution to MA only.
Affected count
40
Manufactured in
4700 S Overland Dr, N/A, Tucson, AZ, United States
Products
EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0968-2016Don't want to check this manually?
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