FDAFDA · Alimentos y medicamentos·N.º oficial Z-0355-2016
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.
Publicado el 9 de diciembre de 2015 · Inicio del retiro: 27 de octubre 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
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Procedure Products, Inc.
- Distribuidor
- Distributed in the states of MT and NY.
- Lote
- Lot 9184-A
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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