Zevex International, Inc.: Curlin PainSmart Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

Recall number

Z-1869-2011

Recalling firm

Zevex International, Inc.

Product

Curlin PainSmart Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

Status

Terminated

Initiated

2011-02-28

Posted

2011-04-05

Terminated

2012-08-06

Reason

Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.

Root 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

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.

Lot, serial or model codes

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, 200699, 200700, 200701, 200703, 200704, 200705, 200706, 200707, 200708, 200709, 200710, 200711, 200714, 200715, 200716, 200717, 200718, 200719, 200720, 200721, 200722, 200724, 200726, 200727, 200728, 200729, 200730, 200731, 200732, 200733, 200735, 200736, 200737, 200738, 200739, 200740, 200741, 200742, 200743, 200745, 200746, 200748, 200749, 200750, 200751, 200752, 200753, 200754, 200756, 200757, 200758, 200759, 200760, 200761, 200762, 200763, 200765, 200768, 200770, 200771, 200772, 200773, 200775, 200776, 200777, 200778, 200780, 200781, 200782, 200783, 200784, 200785, 200786, 200787, 200789, 200791, 200793, 200794, 200795, 200796, 200797, 200798, 200799, 200800, 200803, 200804, 200805, 200806, 200807, 200808, 200809, 200810, 200811, 200813, 200814, 200815, 200816, 200817, 200818, 200819, 200820, 200821, 200823, 200824, 200825, 200826, 200827, 200828, 200829, 200830, 200831, 200833, 200835, 200836, 200837, 200839, 200840, 200841, 200842, 200843, 200846, 200847, 200848, 200849, 200850, 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.

510(k) numbers

["K981816"]

PMA numbers

not on file

Product code

FRN

Firm FEI

1000117172

Firm city

Salt Lake City

Firm state

UT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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