Events

Rappel de Device Recall Sure T

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Unomedical As.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    71332
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1821-2015
  • Date de mise en oeuvre de l'événement
    2015-05-21
  • Date de publication de l'événement
    2015-06-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137324
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Set, administration, intravascular - Product Code FPA
  • Cause
    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
  • Modèle / numéro de série
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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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4263008, 4263009, 4263010, 4263011, 4263012, 4263013, 4263014, 4263015, 4263016, 4263018, 4263019, 4263020, 4263021, 4263022, 4263040, 4263041, 4263042, 4263043, 4263044, 4263045, 4263050, 4263051, 4263052, 4263053, 4263054, 4263055, 4263056, 4263057, 4263058, 4263059, 4263060, 4263061, 4263062, 4263063, 4263075, 4263076, 4263077, 4263078, 4263079, 4263080, 4263081, 4263082, 4263083, 4263084, 4263085, 4263086, 4263096, 4263097, 4263101, 4263102, 4263103, 4263104, 4263105, 4263106, 4263107, 4263108, 4263109, 4263110, 4263111, 4263122, 4263123, 4263124, 4263125, 4263126, 4263127, 4263128, 4263129, 4263139, 4263140, 4263141, 4263142, 4263143, 4263144, 4263164, 4263165, 4263166, 4263167, 4263168, 4263169, 4263173, 4263176, 4263177, 4263184, 4263185, 4263186, 4263187, 4263188, 4263189, 4263194, 4263198, 4263199, 4263200, 4263201, 4263202, 4263217, 4263218, 4263219, 4263220, 4263221, 4263222, 4263223, 4263224, 4263225, 4263226, 4263227, 4263242, 4263243, 4263244, 4263245, 4263246, 4263247, 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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  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Unomedical As, Aholmvej 1 3 Osted, Roskilde Denmark
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    USFDA