Device Recall MR GHIATAS Beaded Breast Localization Wire

  • Model / Serial
    REYB1777 REZI0726 REZI0988 REZK0741 REZL0066 REAN0884
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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. || .
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Bard Peripheral Vascular Inc, 1625 W 3rd St Bldg 1, Tempe AZ 85281-2438
  • Manufacturer Parent Company (2017)
  • Source
    USFDA