Events

Retiro De Equipo (Recall) de Device Recall Sure T

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Unomedical As.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    71332
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1821-2015
  • Fecha de inicio del evento
    2015-05-21
  • Fecha de publicación del evento
    2015-06-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137324
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Set, administration, intravascular - Product Code FPA
  • Causa
    Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
  • Acción
    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
  • Modelo / Serial
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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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  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Dirección del fabricante
    Unomedical As, Aholmvej 1 3 Osted, Roskilde Denmark
  • Empresa matriz del fabricante (2017)
    Triona Holding Sa
  • Source
    USFDA