easy Core Biopsy Device

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    SATP

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lots 0011520534, 0011539483 and 0011543121.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Algeria, Austria, Australia, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Japan and United Arab Emirates.
  • Product Description
    Boston Scientific Easy Core Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-104, REF M0065001040 and M0065001041. || For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
  • Manufacturer
  • Model / Serial
    Lots 0011528037, 0011558750, 0011598779, 0011634769 and 0011712309.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Algeria, Austria, Australia, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Japan and United Arab Emirates.
  • Product Description
    Boston Scientific Easy Core Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-105, REF M0065001050 and M0065001051. || For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
  • Manufacturer
  • Model / Serial
    Lot 0011524376.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Algeria, Austria, Australia, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Japan and United Arab Emirates.
  • Product Description
    Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-106, REF M0065001060 and M0065001061. || For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
  • Manufacturer
  • Model / Serial
    Lots 0011523878 and 0011629943.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Algeria, Austria, Australia, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Japan and United Arab Emirates.
  • Product Description
    Boston Scientific Easy Core Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-107, REF M0065001070 and M0065001071. || For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
  • Manufacturer