Device Recall Malecot Nephrostomy Catheter Set,

  • Modèle / numéro de série
    Expiration Date Range: 1/22/2018 - 10/4/2021; Batch: 16682347 18705536 20623819 16893775 18773341 20658861 16943409 18876327 20685659 17003572 18898595 20735791 17017122 18987890 20798226 17075064 19058167 20830240 17184857 19515680 20884480 17192710 19900108 20909296 17603504 20094213 20942365 17703884 20261038 21055683 17797369 20312726 21129580 17990644 20401204 21157953 18084498 20458382 21179391 18095911 20491743 21218849 18691891 20517726
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distribution: US (nationwide) in the following: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including the District of Columbia and Puerto Rico; and countries of: Argentina, Bolivia, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Peru, Venezuela, Australia, Bangladesh, Botswana, China, Kuwait, Lebanon, Macau, Malaysia, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Turkey, United Arab Emirates, and Zimbabwe.
  • Description du dispositif
    Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 || The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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