Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
Publicado el 26 de octubre de 2016 · Inicio del retiro: 18 de mayo de 2016
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
US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- US Endoscopy Group Inc
- Distribuidor
- US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
- Lote
- Model #: 00711819; Lot 1520268
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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