FDAFDA · Alimentos y medicamentos·N.º oficial Z-0156-2013
Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Trifurcated, BAXA Corporation, Englewood, CO. The Repeater Pump is a device that provides a peristaltic pump driven fluid transfer that facilitates repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers.
Publicado el 31 de octubre de 2012 · Inicio del retiro: 3 de octubre de 2012
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 firm is issuing a field correction to the operators manual included with the 099 Repeater Pump because the Technical Manual was distributed with the device as opposed to the Operator Manual and the instruction for use contradict each other with regards to multiple source container use.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Baxa Corporation
- Distribuidor
- Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Columbia, Guam, Japan, Malaysia, Mexico, Panama, Puerto Rico, Taiwan, UK, and Venezuela.
- Lote
- Repeater Pump model #s 095, 099, and 099R.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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