Events

Retiro De Equipo (Recall) de Device Recall Asante Comfort set

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
    74242
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0355-2017
  • Fecha de inicio del evento
    2014-11-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146920
  • 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
    Tubing detachment.
  • Acción
    ConvaTec sent an Urgent Medical Device Correction letter to all affected consignees on November 7, 2014. The letter notified the consignees of what action they need to take if they experience a detached tubing. You can continue to use your infusion sets by following the advice below. 1. When changing your infusion set, closely follow the instructions for use included in the product box. Check the tubing at the connect/disconnect location identified in the drawings above to make sure it is not loose. 2. As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring. 3. If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure. If you discover the tubing is detached: 1. Do not attempt to reattach the tubing. Replace the infusion set immediately. 2. Treat any high blood sugar based on guidelines provided by your healthcare professional. 3. Call your distributor's Helpline to report the issue. They will give you instructions on how to return the affected infusion set. The letter included a reply card to be returned.

Device

Device Recall Asante Comfort set
  • Modelo / Serial
    5021247, 5021251, 5021253, 5029813, 5031819, 5031820, 5031821, 5031822, 5031823, 5032577, 5032578, 5033752, 5033753, 5033754, 5033755, 5034062, 5034063, 5034064, 5034199, 5034200, 5035085, 5035086, 5035098, 5035099, 5035100, 5037024, 5037025, 5038106, 5038107, 5038108, 5038109, 5038110, 5040382, 5040939, 5040940, 5040941, 5040942, 5040943, 5040944, 5040945, 5040946, 5041053, 5041054, 5041055, 5041056, 5041057, 5043820, 5044874, 5044875, 5044876, 5044877, 5044878, 5044879, 5044880, 5044881, 5044882, 5047110, 5047111, 5047112, 5047113, 5047115, 5047116, 5047117, 5047118, 5047119, 5047121, 5051915, 5053663, 5053664, 5053665, 5053666, 5053667, 5053668, 5053669, 5053670, 5054453, 5054455, 5054456, 5054457, 5054458, 5054459, 5054460, 5054467, 5056817, 5056855, 5056856, 5056857, 5058622, 5058632, 5058636, 5058638, 5058639, 5058640, 5058641, 5058642, 5058735, 5060034, 5060036, 5060037, 5060038, 5060042, 5062768, 5062779, 5062781, 5062782, 5062783, 5062796, 5062814, 5062815, 5065701, 5066393, 5066981, 5066984, 5066992, 5067121, 5067122, 5067123, 5067124, 5067126, 5067127, 5067128, 5067129, 5067130, 5067131, 5067132, 5067133, 5067134, 5067137, 5070832, 5071891, 5071892, 5075507, 5075508, 5075510, 5075533, 5076039, 5077501, 5035530, 5035531, 5035532, 5054472, 5054473, 5054474, 5054479, 5054480, 5063759, 5063760, 5063761
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
  • Descripción del producto
    Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" || The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
  • 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