FDAFDA · Alimentos y medicamentos·N.º oficial Z-1900-2017
MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surgeon to follow in the excision of the lesion. Product Codes 47020, 475201, 477201,479201, and 470201 do not have the ultrasound enhancement shown in Figure 1. In addition,Product Codes 475201, 477201, 479201, and 470201 may be placed under MRI guidance. .
Publicado el 10 de mayo de 2017 · Inicio del retiro: 28 de marzo de 2017
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
It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Bard Peripheral Vascular Inc
- Distribuidor
- Worldwide Distribution - US Nationwide in the states of TX, FL, MO, NJ, WI, AL, TX, CA, OK, AZ, NC, GA, ID, WA, NY, NM and the countries of: Brazil, Canada, China, Taiwan, Canada, and Belgium.
- Lote
- REYB1777 REZI0726 REZI0988 REZK0741 REZL0066 REAN0884
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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