Product Wiki · Recalls · U.S. FDA — Device Enforcement

EndoVive 3s Low Profile Balloon Kits Part Number: M00548820 (XMD P/N 70-0050-120) 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 — recall Z-0918-2016

U.S. FDA — Device Enforcement · United States · 2015-12-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0918-2016
Date of alert: 2015-12-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Xeridiem Mediem Medical Devices Inc
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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