Devices

Device Recall ACCU Chek Tender Set

  • Modèle / numéro de série
    5048997, 5048998, 5048999, 5052118, 5052332, 5052333, 5052334, 5063721, 5066962, 5066963, 5066964
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
  • Description du dispositif
    Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 || The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
  • Manufacturer
    Unomedical As
  • 1 Event

Fabricant

Unomedical As
  • Adresse du fabricant
    Unomedical As, Aholmvej 1 3 Osted, Roskilde Denmark
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    USFDA