Xeridiem Mediem Medical Devices Inc recalls EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)
- Recall date
- December 23, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0968-2016
- FDA classification
- Class II
- Brand / firm
- Xeridiem Mediem Medical Devices Inc
- Sold / distributed
- Nationwide distribution to MA only.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)
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