Device Recall SureT infusion setThe Contact Detach infusion set

  • Model / Serial
    5031810, 5034061, 5034232, 5035097, 5036348, 5038182, 5038183, 5038184, 5038185, 5038186, 5038187, 5038188, 5040990, 5040991, 5040992, 5041073, 5041074, 5045147, 5045148, 5047241, 5047242, 5047243, 5047245, 5048097, 5053689, 5054465, 5054466, 5054550, 5054553, 5054554, 5057103, 5057104, 5057105, 5057106, 5058633, 5058637, 5058731, 5058732, 5058733, 5058734, 5062769, 5062770, 5062780, 5062811, 5062812, 5062813, 5066512, 5066999, 5067219, 5067220, 5067221, 5067222, 5067223, 5067224, 5067225, 5067226, 5067574, 5068464, 5068465, 5071889, 5073670, 5073671, 5075505, 5075509, 5076078, 5054475, 5054476, 5054477, 5054478, 5063762, 5063763
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
  • Product Description
    Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" || The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
  • Manufacturer
  • 1 Event

Manufacturer

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

One device with a similar name

Learn more about the data here

  • Model / Serial
    5038783, 5040464, 5042582, 5042584, 5043414, 5043415, 5046638, 5046639, 5047168, 5049122, 5052903, 5052904, 5056680, 5057219, 5057241, 5057953, 5060205, 5061496, 5063694, 5064402, 5068516, 5068555, 5071403, 5072333, 5073682, 5075554, 5076349, 5043121, 5044843, 5057215, 5064141, 5068515, 5035649, 5035690, 5039578, 5039579, 5039580, 5039581, 5040158, 5040159, 5040465, 5040466, 5040467, 5040468, 5042578, 5042580, 5042581, 5043094, 5043095, 5043100, 5043106, 5043387, 5043417, 5043418, 5043419, 5046393, 5046395, 5046396, 5046640, 5046641, 5047170, 5047171, 5047510, 5047511, 5047580, 5047581, 5047582, 5049123, 5050034, 5050035, 5050036, 5051560, 5051561, 5051562, 5052905, 5052906, 5053786, 5053787, 5053788, 5054558, 5054559, 5055496, 5055497, 5056681, 5056682, 5057047, 5057221, 5057226, 5057231, 5057232, 5057242, 5057243, 5057251, 5057954, 5057955, 5060206, 5060207, 5060208, 5060946, 5060947, 5060948, 5060949, 5060988, 5060989, 5063695, 5063696, 5064142, 5064143, 5064144, 5064145, 5065089, 5065090, 5065106, 5066445, 5066513, 5066514, 5066524, 5067182, 5067183, 5067587, 5067589, 5067590, 5068518, 5068520, 5068522, 5070664, 5072716, 5072717, 5075402, 5075403, 5075555, 5075556, 5075557, 5076350, 5077461, 5077462, 5078949, 5053658, 5064299, 5032640, 5039582, 5039589, 5040469, 5041195, 5043329, 5043420, 5043421, 5046397, 5047172, 5047175, 5047583, 5049124, 5050037, 5051563, 5052907, 5053661, 5056683, 5057244, 5058702, 5058704, 5059523, 5059551, 5059552, 5060209, 5060950, 5061497, 5063697, 5064403, 5066515, 5067184, 5067592, 5068528, 5071405, 5072347, 5072718, 5075404, 5075558, 5077463, 5038779, 5032646, 5040470, 5040471, 5041196, 5043112, 5043114, 5043422, 5043423, 5044841, 5047177, 5047584, 5050038, 5051564, 5052908, 5055463, 5055465, 5056684, 5057245, 5060210, 5060951, 5060952, 5060990, 5067185, 5067593, 5068526, 5070666, 5071406, 5072719, 5075405, 5077464, 5078950, 5057216, 5032652, 5040472, 5040473, 5043117, 5043425, 5043426, 5043427, 5046644, 5046645, 5047179, 5049125, 5053789, 5055498, 5058706, 5058708, 5059553, 5060953, 5060991, 5066516, 5068531, 5070667, 5071407, 5072631, 5076348, 5076353, 5077465, 5039586, 5040474, 5072633, 5079671, 5038787, 5043124, 5043428, 5043429, 5053790, 5064146, 5064404, 5068530, 5068557, 5072634
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
  • Product Description
    SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm || The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
  • Manufacturer