FDAFDA · Alimentos y medicamentos·N.º oficial Z-0932-2016
EndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD P/N 70-0050-324) 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.
Publicado el 2 de marzo de 2016 · Inicio del retiro: 23 de diciembre de 2015
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Xeridiem Mediem Medical Devices Inc
- Distribuidor
- Nationwide distribution to MA only.
- Lote
- Part Number: M00549470 (XMD P/N 70-0050-324) Lot Number: 930153
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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