FDAFDA · Alimentos y medicamentos·N.º oficial Z-0736-2017
BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿ Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD¿ Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.
Publicado el 21 de diciembre de 2016 · Inicio del retiro: 3 de agosto 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
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- C.R. Bard, Inc.
- Distribuidor
- Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.
- Lote
- Product Code: 0038470, Lot Numbers: NGZC3890, NGZC4955, NGZD0763, NGZD2107, NGZD3104, NGZD3990, NGZD4739, NGZE1149, NGZE2054, NGZE3535, NGZF0244, NGZF1565, NGZF2670, NGZF4104 and NGZF5006.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States