FDAFDA · Food and drugs·Recall number Z-0993-2016
EndoVive 3s Low Profile Balloon Kits Part Number: M00549560 (XMD P/N 70-0050-C24) 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 Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Published March 2, 2016 · Recall initiated: December 23, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Xeridiem Mediem Medical Devices Inc
- Distributor
- Nationwide distribution to MA only.
- Lot
- Part Number: M00549560 (XMD P/N 70-0050-C24) Lot Number: 930830
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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