FDAFDA · Alimentos y medicamentos·N.º oficial Z-2766-2018
Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
Publicado el 26 de septiembre de 2018 · Inicio del retiro: 21 de junio de 2018
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
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Degania Silicone, Ltd.
- Distribuidor
- Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.
- Lote
- S17002091, S17002440, S17001607, S17002441, S17002558, S17002559, S17002561, S17002562, S17002563, S17002681, S17003391, S17004379, S17002560, S17002682, S17003456, S17003219, S17003301, S17003302, S17004772, S17004376, S17004377, S17004378, S17005117, S17005029, S17005281, S17005983, S17006720, S17004509, S17004510, S17004511, S17004771, S17004902, S17005028, S17005030, S17005529, S17005984, S17005985, S17004380, S17005979, S17006723, S17005980, S17005981, S17005982, S17005986, S17006718, S17006719, S17006721, S17006722, S17006724, S17006725, S17007360, S17007459, S17007622, S17002986, S17006363, S17007623, S17002987, S17007806, S17008017, S17002090
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Israel
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