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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Product Detail

Product Description Applied Medicals Epix® and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
Recall Number Z-1521-2013
Classification Class II
Code Info 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
Product Distributed Qty 127,305 units
Reason For Recall Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix® and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in permanent patient injury is highly unlikely; however, out of an abundance of caution for patient safety and a commitment to provide only the highest quality products, Applied has decided to recall all potentially affected units.

Event Detail

Event Id 65217
Product Type Devices
Status Ongoing
Recalling Firm Applied Medical Resources Corp
City Rancho Santa Margarita
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
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