Events

Retiro De Equipo (Recall) de Device Recall Endobronchial Tubes

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 Teleflex Medical.

¿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
    52823
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1941-2009
  • Fecha de inicio del evento
    2009-07-31
  • Fecha de publicación del evento
    2009-09-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84076
  • 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
    Connector, airway (extension) - Product Code BZA
  • Causa
    The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs.
  • Acción
    Teleflex Medical, Inc. notified consignees via overnight mail starting July 31, 2009 requesting acknowledgement of the recall and a request to return all of the affected product. Distributors were instructed to forward the letter to their consignees and retrieve relevant product from those locations. Affected product received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. For further information, contact Teleflex Medical at 1-919-433-4986.

Device

Device Recall Endobronchial Tubes
  • Modelo / Serial
    Catalog Number: 5-16028, Lot Numbers: 1163823, 1206612, 1223205, 1231357, 1244556, 1252502, X1240217, 01F0800193, 01F0800289 and 01L0800169;   Catalog Number: 5-16035, Lot Numbers: 1138516, 1140269, 1142027, 1143591, 1143610, 1143775, 1145101, 1145384, 1146183, 1148986, 1149631, 1150442, 1155626, 1157564, 1164122, 1165476, 1169574, 1170554, 1174447, 1178483, 1183447, 1185568, 1189653, 1194375, 1195121, 1201934, 1209310, 1210115, 1211569, 1216011, 1235840, 1238472, 1241371, 1241505, 1243845, 1244254, 1252504, 1258990, 1261906, 1263704, 1264908, 1263863, 1268698, 1271774, 1271775, 1274789, 1279285, 1280242, X1148352, X1158229, 01L0700413, 01L0700299, 01A0800102, 01B0800270, 01C0800185, 01D0800066, 01D0800257, 01F0800056, 01F0800191, 01F0800288, 01H0800056, 01H0800171, 01J0800458, 01J0800459, 01K0800275, 01K0800276, 01L0800292, 01L0800293, 01M0800058, 01M0800059, 01B0900229, 01C0900084, 01C0900345 and 01D0900001;   Catalog Number: 5-16037, Lot Numbers: 1134390, 1134620, 1135985, 1136800, 1137694, 1139466, 1140266, 1141630, 1143594, 1143781, 1145079, 1145383, 1146242, 1147855, 1149630, 1150443, 1152635, 1153621, 1158924, 1159137, 1165584, 1167116, 1170556, 1175203, 1176065, 1179985, 1183449, 1186327, 1188199, 1189032, 1190949, 1193073, 1193746, 1199353, 1200164, 1201040, 1212368, 1218623, 1224867, 1229983, 1230412, 1231358, 1232761, 1236305, 1237250, 1238139, 1239644, 1240215, 1245593, 1251482, 1252221, 1255615, 1263705, 1264907, 1266782, 1270819, 1273893, 1273896, 1277744, 1280243, 1280705, 1281123, X1179890, X1180634, X1181534, X1238185, 01L0700055, 01L0700056, 01L0700225, 01L0700300, 01M0700001, 01B0800021, 01B0800195, 01B0800356, 01C0800106, 01C0800186, 01D0800215, 01E0800063, 01E0800232, 01E0800328, 01F0800290, 01F0800355, 01G0800319, 01H0800403, 01J0800074, 01J0800149, 01J0800222, 01J0800223, 01K0800011, 01K0800038, 01K0800147, 01L0800067, 01L0800068, 01L0800523, 01L0800524, 01M0800206, 01M0800272, 01M0800317, 01A0900043, 01A0900125, 01C0900361;   Catalog Number: 5-16039, Lot Numbers: 1133790, 1135142, 1136768, 1139464, 1140267, 1142034, 1152984, 1156320, 1161353, 1162526, 1164081, 1167117, 1170557, 1171390, 1173367, 1173518, 1179984, 1184132, 1184133, 1186959, 1191585, 1198623, 1202821, 1205971, 1206609, 1207350, 1215046, 1215133, 1220397, 1225847, 1234644, 1238473, 1239645, 1240216, 1246654, 1252180, 1255614, 1263866, 1266009, 1270820, 1270821, 1271773, 1273897, 1273898, 1281125, 01K0700058, 01K0700359, 01L0700149, 01B0800196, 01B0800357, 01C0800351, 01D0800068, 01E0800133, 01E0800397, 01E0800398, 01G0800370, 01J0800328, 01J0800329, 01K0800503, 01K0800504, 01A0900044, 01B0900081 and 01B0900404; and   Catalog Number: 5-16041, Lot Numbers: 1144302, 1161067, 1167582, 1172627, 1175218, 1185570, 1190334, 1193744, 1197170, 1215132, 1228699, 1232762, 1233315, 1274787, 1280244, X1240255, 01K0700159, 01B0800358, 01E0800327, 01H0800058, 01H0800170 and 01M0800060.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S. Nationwide, Canada, Mexico, Europe, India, Asia Pacific Rim, South and Latin America. (Including: Malaysia, Hong Kong, Vietnam, Singapore, Thailand, Korea, China, Japan, Philippines, Australia, New Zealand, France, Germany, Ireland, Sweden, Costa Rica, Puerto Rico, Jamaica, Brazil, Argentina, Uruguay and Colombia).
  • Descripción del producto
    Hudson RICA¿ Sheridan, ET Tube, Sher-I-Bronch LS, 28FR, 35FR, 37FR, 39FR and 41FR, Teleflex Medical, Research Triangle Park, NC 27709. || Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Dirección del fabricante
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA