FDAFDA · Alimentos y medicamentos·N.º oficial Z-0804-2019
Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchial respiratory pathways, in conjunction with endoscopic accessories. The bronchoscopes can also be used endoscopically to visualize the tracheobionchial respiratory tract via the natural passage (oral). Tracheoscope tubes are used as follows: 1. The tube is used as a passage to the area to be examined or treated and allows the insertion of auxiliary instruments such as forceps, resector, remover , suction device and stents; 2. The internal diameter allows the conveying of gases for artificial respiration of the patient and via the ventilation connector in conjunction with the telescope element, the tube can be connected to all known respiration and anasthetic systems; 3. Sampling channel for respiratory gas analysis when gas for analysis is gained from the patient s central respiratory tract by means of the bypass method via the tracheoscope tube. M = identification on Luer connector; 4.Tracheoscopes are used in the trachea up to the tracheal bifurcation.
Publicado el 13 de febrero de 2019 · Inicio del retiro: 17 de octubre de 2018
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Richard Wolf GmbH
- Distribuidor
- Worldwide distribution - US Nationwide in the states of PA, MD, NY, and countries of Bangladesh, Canada, China, France, Germany, India, Italy, Jordan, Netherlands, Poland, Russia, Spain, Thailand, Turkey.
- Lote
- All lot numbers manufactured from October 30, 2006 to August 15, 2018, with affected Product and Lot Numbers distributed worldwide - Product Number (Lot Numbers): 825200641 (1271924, 1074548, 1186516, 1364805, 1262505, 1269165, 1313148, 1296901, 1330427, 1382941, 1321674, 1339578, 1265501, 1344236, 1261415, 1372437, 1353961, M054680, M118520, 1003492, 1058979, 1287750); 825200842 (1189516, 1074551, 1319855, 1298913, 1057370, M054700, M118540); 825201041 (1269824, 1277860, 1186520, 1195261, 1230705, 1340401, 1253661, 1263078, 1288520, 1186520 , 1227431, 1368550, 1376018, 1382289, 1316167, 1104163, 1074553, 1307329, 1296285, 1332473, 1319856, 1053400, 1337541, M054720, M118550); 825201241 (1185831, 1372500, 1364881, 1238365, 1273017, 1302457, 1298771, 1186521, 1269168, 1183846, 1323532, 1074555, 1316169, 1344797, 1333774, 1057371, 1361470, 1265502, 1289744, M054730, M118560); 825201441 (1185832, 1189518, 1339287, 1274102, 1281289, 1320136, 1314041, 1360269, 1328548, 1003493, 1074556, M054740, M112910); 825210830 (1264551, 1313443, 1338468, 1212278, 1262656, 1271357, 1320727); 825211030 (1271954, 1293167, 1287813, 1313444, 1265025, 1320728, 1212279, 1342362); 825211230 (1240940, 1253421, 1245260); 825211430 (1253422, 1240941); 825200841 (1274105, 1185829, 1281667, 1257138, 1368638, 1306948, 1265989, 1296284, 1298436, 1189515, 1269820, 1319630, 1376097, 1362251, 1323968, 1107980, 1333771, 1261416, 1378166, 1053398, 1338467, 1288856, 1074550, M054690, M118530, 1241165, 1243611, 1248730, 1253658, 1262506); Affected Part and Lot numbers distributed Nationwide - Part Number (Lot Numbers): 82520.0641 (1058979, 1074548, 1339578, 1003492, 1313148, M054680, 1186516, 1271924, 1262505, 1269165, 1296901, 1364805, 1330427, 1344236, M118520, 1287750, 1353961, 1382941); 82520.0841 (1074550, 1333771, 1323968, M054690, 1281667, 1274105, 1241165, 1053398, 1269820, 1243611, 1248730, 1262506, 1288856, 1298436, M118530, 1362251, 1185829, 1198515, 1338467, 1378166, 1253658, 1296284); 82520.0842 (M118540, M054700, 1189516, 1319855); 82520.1041 (1074553, 1319856, 1316167, 1277860, M054720, 1053400, 1269824, 1230705, 1253661, 1263078, 1376018, 1288520, 1332473, M118550, 1337541, 1186520, 1195261, 1382289); 82520.1241 (1074555, 1333774, 1302457, 1057371, M054730, 1269168, M118560, 1238365, 1186521, 1289744, 1372500, 1298771, 1344797, 1361470, 1265502, 1185831); 82520.1441 (1074556, 1320136, 1003493, 1314041, 1281289, M054740, M112910, 1189518, 1360269, 1274102, 1339287, 1328548); 825210830 (1271357, 1313443, 1212278, 1262656, 1320727, 1264551, 1338468); 825211030 (1320728, 1313444, 1212279, 1265025, 1342362, 1293167, 1287813); 825211230 (1245260, 1253421, 1240940); 825211430 (1240941, 1253422)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Germany
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