Devices

Device Recall Endobronchial Tubes

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 5-16142, Lot Numbers: 1162530, 1167118, 1169739, 1169740, 1190331, 1200165 and 1207348.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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).
  • 제품 설명
    Hudson RICA¿ Sheridan, Sher-I-Bronch Accessory Pack, 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
  • 1 Event

제조사

Teleflex Medical
  • 제조사 주소
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA

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Device Recall Endobronchial Tubes
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 5-15301, Lot Numbers: 1132962, 1135424, 1136773, 1169645, 1173522, 1178399, 1188200, 1186993, 1194489,1201020, 1212344, 1258338, 1269036, 01L0700243, 01A0800245, 01C0800104, 01E0800341, 01F0800283, 01F0800354, 01L0800005, 01M0800250 and 01A0900036; and   Catalog Number: 5-15401, Lot Numbers: 1152620, 1153518, 1153626, 1155031, 1156400, 1156986, 1157666, 1160298, 1164076, 1169644, 1168080, 1172007, 1173521, 1182297, 1186762, 1193750, 1195118, 1276554, X1198365, X1198635, 01B0800103, 01F0800284, 01G0800362, 01H0800175, 01J0800015, 01A0900367 and 01D0900087.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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).
  • 제품 설명
    Hudson RICA¿ Sher-I-Swiv & Sher-I-Swiv F/O, 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
Device Recall Endobronchial Tubes
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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).
  • 제품 설명
    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
Device Recall Endobronchial Tubes
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 5-16128, Lot Numbers: 1169573, 1183453, 1186960, 1197168, 1205969, 1219532, 1233316, 1247807, 1256372, X1177389, 01K0800372 and 01D0900068;   Catalog Number: 5-16135, Lot Numbers: 1138507, 1141035, 1145947, 1146249, 1148606, 1151231, 1152184, 1157033, 1169746, 1174454, 1176787, 1186981, 1190223, 1193745, 1198626, 1242901, 1256154, 1274788, 1279286, 1281124, 01K0700161, 01L0700414, 01A0800144, 01H0800280 and 01K0800146;   Catalog Number: 5-16137, Lot Numbers: 1137695, 1140908, 1142035, 1144366, 1147062, 1148460, 1151236, 1152636, 1153628, 1154943, 1182363, 1187556, 1190332, 1192253, 1198625, 1241506, 1241616, 1244557, 1270823, 1278941, 1279287, X1158231, X1184238, X1189657, X49036, 01K0700357, 01L0700150, 01L0700226, 01E0800064, 01E0800132, 01E0800400, 01F0800057, 01F0800356, 01G0800167, 01K0800123, 01K0800384 and 01L0800167;   Catalog Number: 5-16139, Lot Numbers: 1136908, 1141067, 1142803, 1155672, 1162104, 1163822, 1172148, 1175219, 1179997, 1183450, 1190333, 1192254, 1219531, 1247271, 1270822, 1273899, 01K0700060, 01K0700258, 01C0800327, 01E0800399, 01F0800192, 01K0800385 and 01A0900218; and   Catalog Number: 5-16141, Lot Numbers: 1141964, 1162103, 1172149, 1185571, 1197167, X1176100 and 01C0800328.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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).
  • 제품 설명
    Hudson RICA¿ Sheridan, ET Tube, Sher-I-Bronch RS, 28FR, 35 FR, 37 FR, 39FR and 41 FR, 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
Device Recall Endobronchial Tubes
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: V5-16035, Lot Numbers: 1140268, 1140907, 1170555, 1178484, 1183448, 1194376, 1201935, 1208297, 1244546, 1275365, 01A0800182, 01D0800258, 01H0800057 and 01H0800402;   Catalog Number: V5-16037, Lot Numbers: 1145385, 1153622, 1158906, 1160679, 1163824, 1176066, 1182302, 1185569, 1190950, 1193074, 1199354, 1236306, 1246651, 1271778, 1278921, 1280706, 01K0700358, 01B0800201, 01C0800187, 01G0800445, 01J0800075 and 01A0900206;   Catalog Number: V5-16039, Lot Numbers: 1133751, 1152985, 1161068, 1164080, 1170555, 1176067, 1184133, 1191586, 1197169, 1198624, 1214179, 1215134, 1234645, 1266007, 166785, 1268697, 1271779, 01B0800049, 01B0800202, 01C0800352, 01G0800444 and 01A0900241; and   Catalog Number: V5-16041, Lot Numbers: 1167165, 1178485, 1197171, 1205970, 01K0700160 and 01K0800041.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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).
  • 제품 설명
    Hudson RICA¿ Sheridan, EB Tube, Sher-I-Bronch, LS, 35FR, Nova Plus, 37FR, 39 FR, and 41 FR, 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