Class 1 Device Recall Ambulatory Infusion Pump

• Date Initiated by Firm: February 28, 2011
• Date Posted: April 05, 2011
• Recall Status: Terminated on August 06, 2012
• Recall Number: Z-1869-2011
• Recall Event ID: 57939
• 510(K)Number: K981816
• Product Classification: Pump, infusion - Product Code FRN
• Product: Curlin PainSmart Ambulatory Infusion Pump; ; Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
• Code Information: 200078, 200080, 200081, 200086, 200086, 200090, 200092, 200097, 200103 200109, 200110, 200116, 200118, 200118, 200119, 200124, 200125, 200129 200135, 200136, 200137, 200137, 200143, 200143, 200144, 200144, 200147 200153, 200154, 200155, 200157, 200159, 200164, 200164, 200166, 200167, 200184, 200185, 200186, 200187, 200272, 200409, 200456, 200488, 200492, 200504, 200505, 200506, 200511, 200516, 200517, 200518, 200519, 200521, 200523, 200524, 200525, 200540, 200541, 200543, 200546, 200548, 200550, 200553, 200556, 200569, 200570, 200571,200581, 200593, 200601, 200605, 200633, 200634, 200635, 200636, 200641, 200644, 200645, 200646, 200647, 200649, 200650, 200651, 200652, 200653, 200654, 200655, 200656, 200657, 200659, 200660, 200662, 200663, 200664, 200665, 200666, 200667, 200668, 200670, 200673, 200674, 200675, 200677, 200678, 200679, 200680, 200681, 200683, 200684, 200685, 200686, 200687, 200688, 200689, 200690, 200691, 200693, 200694, 200695, 200696, 200697, 200698, 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200851, 200853, 200854, 200855, 200858, 200859, 200860, 200861, 200862, 200863, 200864, 200865, 200866, 200868, 200869, 200870, 200872, 200873, 200874, 200875, 200876, 200877, 200880, 200882, 200883, 200884, 200885, 200886, 200887, 200888, 200889, 200891, 200892, 200893, 200894, 200895, 200896, 200897, 200899, 200900, 200902, 200903, 200904, 200905, 200906, 200907, 200908, 200909, 200910, 200912, 200913, 200914, 200915, 200916, 200917, 200918, 200919, 200920, 200923, 200924, 200925, 200926, 200927, 200928, 200929, 200930, 200931, 200933, 200934, 200935, 200937, 200938, 200939, 200941, 200942, 200946, 200955, 200971, 200975, 200993, 200996, 200998, 201000, 201002, 201006, 201010, 201012, 201014, 201015, 201016, 201018, 201024, 201034, 201038, 201041, 201045, 201046, 201054, 201055, 201056, 201063, 201064, 201065, 201067, 201068, 201075, 201076, 201079, 201080, 201165, 201245, 201284, 201295, 201296, 201299, 201324, 201345, 201347, 201356, 201357, 201358, 201361, 201363, 201364, 201365, 201366, 201367, 201368, 201370, 201371, 201379, 201407, 201409, 201411, 201414, 201417, 201427, 201428, 201429, 201431, 201432, 201433, 201434, 201435, 201436, 201437, 201438, 201439, 201441, 201442, 201459, 201460, 201461, 201463, 201465, 201467, 201470, 201548, 201674, 201678, 201679, 201681, 201683, 201685, 201694, 201700, 201713, 201714, 201715, 201716, 201718, 201719, 201720, 201724, 201725, 201732, 201734, 201736, 201737, 201739, 201740, 201741, 201745, 201759, 201770, 201771, 201773, 201776, 201778, 201779, 201780, 201781, 201782, 201789, 201791, 201793, 201794, 201795, 201800, 201804, 201810, 201812, 201814, 201816, 201817, 201830, 201830, 201830, 201860, 201861, 201862, 201864, 201866, 201868, 201879, 201880, 201882, 201884, 201912, 201918, 201952, 201996, 202010, 202033, 202035, 202038, 202040, 202042, 202043, 202053, 202062, 202063, 202065, 202066, 202067, 202068, 202069, 202076, 202078, 202079, 202081, 202082, 202083, 202084, 202085, 202086, 202087, 202091, 202098, 202100, 202101, 202102, 202103, 202104, 202106, 202107, 202109, 202111, 202112, 202113, 202114, 202115, 202116, 202117, 202118, 202125, 202126, 202127, 202128, 202129, 202130, 202131, 202132, 202157, 202159, 202161, 202162, 202170, 202171, 202172, 202173, 202174, 202175, 202196, 202197, 202198, 202199, 202200, 202201, 202202, 202203, 202204, 202208, 202209, 202212, 202213, 202214, 202215, 202216, 202218, 202220, 202232, 202233, 202234, 202236, 202237, 202238, 202239, 202243, 202244, 202273, 202274, 202279, 202281, 202284, 202285, 202294, 202305, 202323, 202332, 202334, 202335, 202336, 202337, 202338, 202340, 202341, 202342, 202345, 202346, 202347, 202348, 202349, 202350, 202351, 202352, 202355, 202358, 202361, 202362, 202382, 202395, 202404, 202419, 202542, 202552, 202757, 202774, 202783, 202801, 202807, 202808, 202810, 202811, 202813, 202815, 202816, 202817, 202819, 202823, 202841, 202842, 202843, 202845, 202847, 202848, 202849, 202894, 202918, 202919, 202951, 202987, 202988, 202990, 202991, 202992, 202996, 202997, 203198, 203413, 203414, 203415, 203417, 203418, 203835, 203900, 203924, 203936, 203939, 203953, 203976, 204025, 204026, 204027, 204253, 205531, 205583, 205995, 206053, 206216, 206462, 206688, 206724, 206726, 206732, 206745, 206747, 206836, 206841, 206863, 206864, 206865, 206866, 207186, 207413, 207430, 207512, 207513, 207587, 207628, 207695, 207695, 207762, 207778, 207807, 207807, 207810, 208003, 208049, 208060, 208183, 208198, 208298, 210022, 210025, 210026, 210028, 210029, 210030, 210031, 210073, 210075, 210076, 210077, 210078, 210096, 210137, 210138, 210140, 210142, 210143, 210144, 210150, 210204, 210232, 210262, 210263, 210291, 210292, 210350, 210356, 210358, 210360, 210444, 210445, 210448, 210452, 210452, 210458, 210477, 210512, 210514, 210536, 210537, 210538, 210539, 210540, 210540, 210541, 210545, 210550, 210553, 210554, 210584, 210626, 210630, 210631, 210632, 210633, 210651, 210667, 210680, 210682, 210684, 210686, 210943, 210946, 210947, 210948, 210993, 211102, 211103, 211218, 211245, 211293, 211294, 211295, 211296, 211298, 211300, 211301, 211302, 211304, 211337, 211457, 211528, 211529, 211531, 211532, 211533, 211534, 211535, 211536, 211537, 211538, 211539, 211541, 211542, 211543, 211544, 211546, 211547, 211548, 211549, 211550, 211552, 211553, 211554, 211555, 211556, 211638, 211640, 211644, 212479, 212505, 212506, 212527, 212533, 212540, 212558, 212560, 212562, 212563, 212565, 212568, 212572, 212573, 212576, 212578, 212581, 212666, 212671, 212686, 212688, 212689, 212690, 212691, 212692, 212696, 212697, 212698, 212701, 212715, 212716, 212752, 212755, 212756, 212760, 213901, 203198.
• Recalling Firm/ Manufacturer: Zevex International, Inc.; 4314 Zevex Park Ln; Salt Lake City UT 84123
• For Additional Information Contact: 801-264-1001 Ext. 144
• Manufacturer Reason for Recall: Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.
• FDA Determined Cause: Software design
• Action: The firm, MOOG, sent an "URGENT DEVICE RECALL NOTIFICATION" letter dated February 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: 1) Identify the affected Pumps: a) If they have an affected pump, fill out and return the enclosed Business Reply Card within five (5) working days. b) If their pump is not affected by this recall, the pump can be used for its intended purposes. 2) Removal of affected Product: a) remove affected products from service and use non-affected pump b) If you do not have an alternate pump available for use, MOOG recommended that they weigh the risks and benefits for delivering medications using the affected pump versus the risk of not using any pump for each patient WARNING: Affected pumps should not be used to deliver critical medications where a delay in therapy could result in serious adverse health effects, injury or death; and affected pumps should not be used with the neonatal population. 3)Should they Have an Affected pump which exhibits Error Code 45 or is used in therapeutic situations specified in the warning, please contact MOOG Customer Service at (800) 970-2337, Monday thru Friday, 7:00am to 5:00pm MST to arrange for a loaner pump and the return of your affected pump. If you have any additional questions regarding this recall, please contact MOOG's Customers Service Department at (800) 970-2337.
• Quantity in Commerce: 918 units
• Distribution: Worldwide distribution: USA and countries including: Australia, Canada, Costa Rica, Croatia, Dubai, France, Germany, Ireland, Italy, Japan, Jordan, Kuwait, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, Taiwan, Turkey, UAE, United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = BECTON DICKINSON CURLIN, LLC.