Events

Recall of Device Recall Sure T

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Unomedical As.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71332
  • Event Risk Class
    Class 2
  • Event Number
    Z-1821-2015
  • Event Initiated Date
    2015-05-21
  • Event Date Posted
    2015-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137324
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Set, administration, intravascular - Product Code FPA
  • Reason
    Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
  • Action
    Each consignee was sent an "Urgent Field Safety Notice Regarding Steel Cannula Infusion Sets" on 5/21/2015 via Express Mail. This notification identified the affected product as well as the reason for the recall. It also contained instructions on how to use the product. Customers were to contact their health care provider if they suspected that a needle had broken off and remained under the skin. Diabetic patients were to monitor their blood sugar and non diabetic patients were to monitor symptoms which would indicate drug delivery had failed. Questions should be directed to the persons identified in the letter.

Device

Device Recall Sure T
  • Model / Serial
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220529, 220530, 220534, 220664, 220665, 220666, 220667, 220668, 220669, 220670, 220671, 220672, 220673, 220674, 220675, 220676, 220677, 220678, 220679, 220680, 220681, 220682, 220683, 221883, 223620, 223621, 223862, 223864, 223869, 223874, 223876, 223881, 223888, 223889, 223890, 223973, 223974, 223975, 224287, 224288, 224289, 224290, 224291, 224292, 224293, 224294, 224295, 224599, 224604, 224621, 224622, 224811, 224812, 224813, 224814, 225554, 225555, 225556, 225557, 225558, 225559, 225560, 226026, 226027, 226028, 226029, 226030, 226031, 226870, 226871, 226872, 227746, 227747, 227748, 227749, 228088, 228089, 228090, 228091, 228092, 228093, 229307, 229308, 229309, 229310, 229311, 229530, 229531, 229532, 229533, 229534, 220535, 220536, 230162, 230268, 230269, 230270, 230271, 230272, 230406, 230503, 230504, 231155, 231156, 231157, 231158, 231159, 231160, 231161, 232703, 232704, 232705, 232706, 234148, 234149, 234154, 234155, 234156, 234171, 234172, 234173, 234174, 234183, 234188, 234193, 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4263248, 4263249, 4263250, 4263251, 4263252, 4263253, 4263256, 4263257, 4263258, 4263259, 4263260, 4263261, 4263262, 4263270, 4263271, 4263272, 4263273, 4263274, 4263275, 4263290, 4263291, 4263292, 4263293, 4263294, 4263315, 4263316, 4263317, 4263318, 4263319, 4263320, 4263339, 4263340, 4263341, 4263342, 4263343, 4263344, 4263345, 4263346, 4263347, 4263365, 4263366, 4293367, 4263368, 4263369, 4263370, 4263371, 4263373, 4263374, 4263375, 4263376, 4263377, 4263378, 4263379, 4263380, 4263381, 4263382, 4263383, 4263392, 4263395, 4263396, 4263397, 4263398, 4263399, 4263413, 4263414, 4263415, 4263416, 4263417, 4263418, 4263426, 4263427, 4263428, 4263429, 4263430, 4263431, 4263432, 4263446, 4263447, 4263448, 4263449, 4263459, 4263460, 4263461, 4263462, 4263463, 4263469, 4263470, 4263471, 4263473, 4263477, 4263478, 4263479, 4263487, 4263488, 4263489, 4263490, 4263491, 4263496, 4263497, 4263498, 4263499, 4263500, 4263519, 4263520, 4263521, 4263522, 4263523, 4263527, 4263528, 4263530, 4263532, 4263533, 4263534, 4263546, 4263547, 4263548, 4263549, 4263550, 4263554, 4263555, 4263556, 4263566, 4263567, 4263568, 4263569, 4263570, 4263573, 4263574, 4263575, 4263576, 4263577, 4263581, 4263582, 4263583, 4263584, 4263585, 4263586, 4263603, 4263604, 4263605, 4263606, 4263607, 4263608, 4263613, 4263614, 4263615, 4263616, 4263617, 4263618, 4263619, 4263620, 4263621, 4263622, 4263623, 4263625, 4263626, 4263627, 4263628, 4263629, 4263630, 4263634, 4263635, 4263636, 4263637, 4263638, 4263639, 4263640, 4263647, 4263648, 4263649, 4263650, 4263651, 4263679, 4263680, 4263681, 4263682, 4263683, 4263691, 4263692, 4263693, 4263697, 4263698, 4263699, 4263700, 4263701, 4263702, 4263708, 4263709, 4263710, 4263711, 4263712, 4263713, 4263714, 4263715, 4263717, 4263720, 4263721, 4263722, 4263723, 4263724, 4263727, 4263728, 4263729, 4263730, 4263731, 4263732, 4263733, 4263734, 4263735, 4263736, 4263737, 4263743, 4263744, 4263745, 4263746, 4263747, 4263748, 4263749, 4253756, 4263757, 4263787, 5000126, 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5010867, 5010868, 5011144, 5011145, 5011146, 5011147, 5011148, 5011149, 5011150, 5011151, 5011152, 5011153, 5011835, 5011836, 5011837, 5011838, 5013133, 5013134, 5013807, 5013808, 5013809, 5013810, 3015152, 5015153, 5015154, 5015155, 5015156, 5016592, 5016595, 5016922, 5016923, 5016924, 5016925, 5016926, 5017077, 5017079, 5017081, 5017083, 5017085, 5017112, 5017113, 5017114, 5017115, 5017116, 5017117, 5017118, 5017119, 5017464, 5017466, 5017467, 5017629, 5017632, 5017636, 5017642, 5017653, 5017731, 5017732, 5017733, 5017734, 5017735, 5017736, 5019180, 5019182, 5019183, 5019185, 5019459, 5019460, 5019461, 5020537, 5020538, 5020539. 5020540, 5020541, 5020542, 5020543, 5020544, 5025445, 5025446, 5021555, 5021556, 5021557, 5021558, 5022230, 5022231, 5022232, 5022233, 5022954, 5022955, 5022956, 5022957, 5022958, 5023461, 5023462, 5023463, 5023464, 5023465, 5023466, 5023467, 5023468, 5023469, 5023470, 5024494, 5024495, 5024496, 5026739, 5026740, 5026741, 5026882, 5026883, 5028244, 5028245, 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  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of CA, IL, MN, and PA; and, the countries of Australia, Bahrain, Belgium, Canada, China, Cypress, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Kuwait, Lebanon, Malaysia, Maldives, Oman, Schweiz, South Africa, Spain, Sweden, Switzerland, Netherlands, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset || Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
  • Manufacturer
    Unomedical As

Manufacturer

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