Devices

Device Recall Comfort and Comfort Short infusion setACCU Chek Tender Set

  • Model / Serial
    5032433, 5033654, 5037164, 5040419, 5044362, 5046682, 5051308, 5053298, 5058508, 5061927, 5062202, 5065546, 5069297, 5072252, 5075118, 5044359, 5053289, 5061929, 5032436, 5033657, 5037159, 5040420, 5044355, 5046683, 5051309, 5053299, 5058501, 5061928, 5062205, 5065539, 5069295, 5072249, 5032442, 5033662, 5037162, 5040424, 5044361, 5051304, 5053292, 5058505, 5061931, 5061933, 5062208, 5032438, 5037160, 5044360, 5051310, 5053300, 5062211, 5069296, 5072253, 5032439, 5032440, 5033659, 5033660, 5037161, 5040422, 5044365, 5046684, 5051303, 5053297, 5058503, 5061939, 5062212, 5065550, 5065551, 5069298, 5072250, 5075121, 5032441, 5033661, 5037167, 5040423, 5044366, 5046681, 5051311, 5053293, 5058504, 5061930, 5065552, 5069301, 5072254, 5033658, 5044363, 5062206, 5062207, 5065540, 5065541, 5065542, 5069302, 5072251
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
  • Product Description
    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs || The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
  • Manufacturer
    Unomedical As
  • 1 Event

Manufacturer

Unomedical As
  • Manufacturer Address
    Unomedical As, Aholmvej 1 3 Osted, Roskilde Denmark
  • Manufacturer Parent Company (2017)
    Triona Holding Sa
  • Source
    USFDA