Device Recall Epix and Direct Drive Laparoscopic Graspers

  • Modèle / numéro de série
    Model Numbers C4130 and C4140.  MODEL NUMBERS    C4130- 5mm x 35cm Epix/Direct Drive Laparoscopic Grasper  LOT NUMBERS  1145332, 1145943, 1145944, 1145945, 1145992, 1145993, 1145994, 1146371, 1147900, 1147901, 1147955, 1148172, 1148173, 1148174, 1148180, 1148181, 1148184, 1148190, 1148191, 1148192, 1148194, 1148201, 1148203, 1148677, 1148765, 1148766, 1148767, 1148835, 1149040, 1149041, 1149690, 1149757, 1150168, 1150169, 1150170, 1150490, 1150634, 1151246, 1151247, 1151248, 1152274, 1152728, 1153332, 1154394, 1154637,  1155135, 1155473, 1155948, 1156004, 1156010, 1156011, 1156012, 1156270, 1156360, 1156452, 1156577, 1156857, 1157218, 1157679, 1157950, 1157951, 1157952, 1157953, 1157954, 1158052, 1158131, 1158216, 1158217, 1158425, 1159491, 1160167, 1161136, 1161137, 1161398, 1161638, 1162112, 1162503, 1162504, 1162588, 1163399, 1163558, 1163559, 1163575, 1164580, 1164581, 1164582, 1164583, 1168124, 1168637, 1168638, 1169117, 1171168, 1171631, 1172170, 1172668, 1173153, 1174995, 1174996, 1176616, 1177407, 1177408, 1178109, 1180295, 1181554, 1182940, 1183774, 1184416, 1184959, 1187241, 1188110, 1188745, 1189773, 1191368, 1191809.  C4140- 5mm x 45cm Epix/Direct Drive Laparoscopic  Grasper  1145559, 1147851, 1147852, 1147960, 1148210, 1148211, 1149038, 1149039, 1149689, 1149936, 1150488, 1150489, 1151249, 1152594, 1153330, 1155645, 1157217, 1157949, 1158644, 1160033, 1160170, 1162111, 1167871, 1169855, 1171497, 1172009, 1173587, 1174121, 1177578, 1179347, 1180753, 1181346, 1182924, 1183769, 1184961, 1188111, 1189182  Various Kits Containing Either C4130 or C4140 1148079, 1148139, 1148145, 1148250, 1148514, 1148770, 1148780, 1149100, 1149605, 1150455, 1151831, 1153074, 1153702, 1154931, 1154997, 1155332, 1156581, 1156812, 1157090, 1158535, 1160152, 1160227, 1160388, 1161766, 1162189, 1162343, 1163348, 1163881, 1164590, 1164796, 1164831, 1165443, 1166520, 1168227, 1169190, 1169456, 1169620, 1169772, 1170151, 1170378, 1171280, 1171878, 1171879, 1172330, 1173319, 1173903, 1174093, 1175987, 1175991, 1176171, 1178210, 1178498, 1178581, 1179376, 1182679, 1182972, 1183303, 1184673, 1185599, 1185762, 1186257, 1186868, 1187082, 1188827, 1189581, 1190574, 1191055, 1193112, 1193147, 1193648, 1193688, 1194964,  1194965
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA Nationwide and countries of: Argentina, Austria, Australia, Bahrain, Belgium, Canada, Chile, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Jordan, Kuwait, Malaysia, Lebanon, Lybia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Spain, South Africa, Switzerland, Taiwan-Province of China,Turkey, United Arabs Emirates United Kingdom, Uruguay, and Venezula-Bolivarian Republic.
  • Description du dispositif
    Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. || Used for grasping and manipulating tissue during general or laparoscopic surgery.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • Société-mère du fabricant (2017)
  • Source
    USFDA