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Xeridiem Mediem Medical Devices Inc recalls EndoVive 3s Low Profile Balloon Kits Part Number: M00548750 (XMD P/N 70-0050-A18)
Recalled March 2, 2016 · FDA recall Z-0977-2016 · Xeridiem Mediem Medical Devices
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. · FDA Class II
Units
39
Sold at
Nationwide distribution to MA only.
Description
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.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548750 (XMD P/N 70-0050-A18)
Manufacturer(s)
Xeridiem Mediem Medical Devices Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →