Events

Recall of Device Recall Ambulatory Infusion Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zevex International, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57939
  • Event Risk Class
    Class 1
  • Event Number
    Z-1867-2011
  • Event Initiated Date
    2011-02-28
  • Event Date Posted
    2011-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97786
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • Reason
    Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.
  • 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.

Device

Device Recall Ambulatory Infusion Pump
  • Model / Serial
    Code Information is displayed as an Error Code 36 or Error Code 45 on the affected device.  ERROR CODE 36: 219187, 219283, 219332, 215154, 215749, 215875, 215963, 216063, 219192, 219284, 219335, 215638, 215761, 215877, 215964, 216066, 219196, 219285, 219368, 215640, 215762, 215880, 215965, 216072, 219204, 219286, 219370, 215644, 215764, 215886, 215968, 216076, 219215, 219288, 219311, 215645, 215772, 215891, 215970, 216080, 219216, 219289, 219313, 215650, 215774, 215894, 215976, 216082, 219217, 219290, 219314, 215656, 215776, 215900, 215978, 216083, 219222, 219291, 216116, 215657, 215777, 215907, 215982, 216084, 219227, 219292, 216995, 215659, 215779, 215908, 215983, 216085, 219233, 219293, 212557, 215660, 215780, 215909, 215990, 216086, 219234, 219294, 212709, 215662, 215781, 215911, 215994, 216094, 219240, 219297, 212719, 215664, 215801, 215912, 215995, 216098, 219241, 219299, 212720, 215667, 215804, 215914, 215998, 216100, 219242, 219300, 212881, 215683, 215806, 215915, 215999, 216102, 219245, 219301, 212889, 215685, 215809, 215916, 216000, 216113, 219246, 219302, 212981, 215689, 215810, 215918, 216001, 216120, 219256, 219303, 213002, 215690, 215811, 215919, 216002, 216122, 219257, 219304, 213019, 215692, 215813, 215920, 216004, 216130, 219258, 219305, 213132, 215694, 215816, 215921, 216007, 216131, 219259, 219306, 213133, 215698, 215822, 215923, 216016, 216132, 219260, 219307, 213140, 215699, 215824, 215924, 216017, 216134, 219261, 219308, 213188, 215701, 215825, 215926, 216028, 216136, 219266, 219309, 213205, 215703, 215827, 215930, 216033, 216147, 219267, 219310, 213283, 215706, 215829, 215932, 216038, 216148, 219268, 219316, 213298, 215707, 215832, 215933, 216039, 216149, 219270, 219317, 213419, 215710, 215833, 215936, 216042, 216152, 219271, 219319, 214407, 215713, 215836, 215938, 216044, 216155, 219272, 219320, 214421, 215721, 215837, 215939, 216047, 216157, 219273, 219321, 214482, 215722, 215843, 215949, 216048, 216159, 219274, 219322, 214486, 215725, 215846, 215950, 216050, 216162, 219275, 219323, 215023, 215729, 215847, 215953, 216051, 216164, 219276, 219324, 215024, 215733, 215849, 215954, 216052, 216166, 219277, 219325, 215025, 215735, 215851, 215956, 216054, 216169, 219279, 219326, 215027, 215738, 215858, 215959, 216055, 216172, 219280, 219327, 215063, 215739, 215865, 215960, 216056, 216173, 219281, 219329, 215110, 215745, 215871, 215961, 216059, 216175, 219282, 219330, 215129, 215748, 215872, 215962, 216062, 216176,  216177, 216329, 216431, 216558, 216816, 216895, 217000, 217116, 216179, 216330, 216435, 216569, 216818, 216898, 217002, 217119, 216181, 216332, 216442, 216576, 216820, 216899, 217003, 217121, 216187, 216333, 216446, 216577, 216823, 216902, 217006, 217122, 216188, 216334, 216447, 216578, 216824, 216903, 217012, 217123, 216190, 216337, 216448, 216580, 216827, 216919, 217030, 217124, 216191, 216339, 216449, 216581, 216828, 216920, 217037, 217131, 216195, 216341, 216451, 216582, 216830, 216922, 217040, 217135, 216210, 216342, 216453, 216586, 216832, 216923, 217042, 217142, 216211, 216343, 216455, 216587, 216835, 216924, 217043, 217144, 216212, 216344, 216459, 216589, 216838, 216925, 217054, 217145, 216215, 216345, 216466, 216594, 216839, 216926, 217056, 217146, 216216, 216350, 216467, 216600, 216840, 216927, 217057, 217147, 216218, 216357, 216471, 216601, 216841, 216928, 217058, 217149, 216219, 216359, 216474, 216602, 216842, 216929, 217059, 217150, 216220, 216361, 216475, 216604, 216843, 216931, 217065, 217151, 216222, 216363, 216476, 216605, 216844, 216937, 217071, 217152, 216225, 216364, 216487, 216606, 216846, 216943, 217072, 217154, 216227, 216369, 216488, 216607, 216847, 216946, 217073, 217155, 216228, 216370, 216491, 216609, 216848, 216947, 217074, 217158, 216229, 216387, 216492, 216610, 216849, 216948, 217076, 217159, 216232, 216389, 216495, 216620, 216853, 216949, 217078, 217160, 216237, 216391, 216501, 216623, 216859, 216950, 217079, 217161, 216238, 216392, 216502, 216625, 216860, 216951, 217080, 217162, 216239, 216393, 216503, 216627, 216861, 216952, 217081, 217164, 216241, 216398, 216507, 216630, 216869, 216953, 217082, 217165, 216249, 216399, 216510, 216734, 216870, 216959, 217083, 217166, 216250, 216400, 216516, 216795, 216877, 216960, 217084, 217168, 216254, 216409, 216529, 216797, 216880, 216973, 217085, 217171, 216257, 216410, 216533, 216799, 216881, 216975, 217087, 217175, 216259, 216412, 216537, 216802, 216882, 216976, 217088, 217176, 216260, 216414, 216539, 216804, 216883, 216979, 217089, 217178, 216263, 216416, 216541, 216805, 216884, 216980, 217090, 217183, 216264, 216417, 216544, 216806, 216885, 216984, 217098, 217190, 216268, 216421, 216546, 216807, 216886, 216989, 217099, 217194, 216277, 216423, 216549, 216808, 216887, 216990, 217102, 217195, 216279, 216425, 216555, 216810, 216893, 216994, 217103, 217200, 216280, 216430, 216557, 216814, 216894, 216997, 217107, 217201,  217202, 217204, 217205, 217206, 217207, 217208, 217209, 217210, 217211, 217212, 217213, 217215, 217217, 217218, 217219, 217221, 217222, 217223, 217224, 217226, 217236, 217237, 217250, 217272, 217418, 217427, 217428, 217429, 217430, 217431, 217432, 217433, 217434, 217435, 217436, 217437, 217438, 217439, 217440.  ERROR CODE 45:   200249, 200262, 200959, 201690, 201829, 202387, 202388, 202406, 202410, 202420, 202447, 202493, 202601, 202789, 206002, 206005, 206006, 206172, 206890, 206906, 207742, 208968, 209630, 210000, 210218, 211334, 211588, 212010, 212038, 212134, 212175, 212186, 212274, 212275, 212276, 212278, 212282, 212283, 212284, 212286, 212288, 212289, 212292, 212293, 212295, 212299, 212301, 212302, 212320, 212321, 212322, 212324, 212325, 212328, 212447, 212448, 212450, 212452, 212453, 212454, 212456, 212457, 212458, 213844, 213916, 213958, 206504, 207223, 200173, 200176, 201019, 202380, 202433, 202437, 202461, 202467, 202585, 202700, 203026, 203043, 203044, 203055, 203056, 203058, 203061, 203062, 203063, 203067, 203069, 203070, 203167, 203170, 203172, 203173, 203183, 203185, 203186, 203201, 203220, 204606, 204615, 204678, 204701, 204703, 204707, 204709, 204710,204716, 204722, 204730, 204731, 204732, 204739, 204743, 204744, 204749, 204754, 204768, 204771, 204773, 204775, 204779, 204786, 204795, 204796, 204801, 204812, 204814, 204903, 205012, 205123, 205634, 205635, 205637, 205641, 205649, 205651, 205654, 205655, 205656, 205658, 205659, 205660, 205661, 205668, 205677, 205687, 205722, 205728, 205736, 205737, 205740, 205745, 205832, 205833, 205846, 205848, 205850, 205851, 205852, 205861, 205863, 205866, 205877, 205883, 205886, 205893, 205895, 205911, 205915, 205916, 205919, 205926, 205928, 205930, 205933, 205952, 205973, 205974, 206014, 206042, 206052, 206056, 206057, 206060, 206067, 206073, 206078, 206128, 206136, 206140, 206141, 206144, 206145, 206156, 206163, 206164, 206165, 206204, 206217, 206218, 206223, 206225, 206243, 206245, 206253, 206254, 206257, 206258, 206262, 206264, 206267, 206272, 206273, 206275, 206293, 206295, 206296, 206302, 206306, 206307, 206318, 206319, 206320, 206321, 206327, 206328, 206335, 206346, 206370, 206381, 206396, 206415, 206428, 206430, 206449, 206464, 206465, 206487, 206489, 206492, 206493, 206506, 206512, 206513, 206515, 206518, 206521, 206529, 206531, 206533, 206546, 206551, 206558, 206560, 206568, 206570, 206571, 206578, 206579, 206580, 206583, 206584, 206585, 206586, 206598, 206599, 206600, 206602, 206603, 206608, 206609, 206610, 206611, 206617, 206628, 206629, 206631, 206632, 206637, 206642, 206644, 206645, 206646, 206647, 206648, 206651, 206653, 206658, 206659, 206665, 206671, 206672, 206674, 206675, 206680, 206689, 206692, 206695, 206696, 206699, 206703, 206710, 206712, 206714, 206717, 206723, 206730, 206733, 206736, 206737, 206741, 206742, 206743, 206748, 206753, 206754, 206756, 206757, 206759, 206761, 206762, 206763, 206769, 206775, 206776, 206783, 206784, 206791, 206795, 206797, 206800, 206801, 206805, 206812, 206823, 206826, 206838, 206845, 206848, 206849, 206850, 206859, 206862, 206874, 206876, 206877, 206879, 206880, 206882, 206883, 206886, 206887, 206889, 206891, 206895, 206896, 206897, 206899, 206902, 206909, 206911, 206920, 206921, 206926, 206927, 206928, 206930, 206934, 206937, 206941, 206943, 206945, 206946, 206947, 206948, 206950, 206951, 206954, 206955, 206956, 206957, 206959, 206962, 206967, 206970, 206982, 206991, 206992, 206993, 206996, 207001, 207003, 207006, 207007, 207008, 207018, 207019, 207024, 207026, 207036, 207037, 207038, 207039, 207040, 207042, 207044, 207045, 207046, 207047, 207048, 207049, 207051, 207052, 207055, 207056, 207057, 207059, 207061, 207066, 207067, 207072, 207076, 207093, 207096, 207097, 207101, 207102, 207103, 207109, 207110, 207112, 207114, 207116, 207132, 207133, 207135, 207136, 207137, 207140, 207145, 207152, 207154, 207164, 207165, 207168, 207170, 207171, 207172, 207173, 207191, 207194, 207196, 207197, 207198, 207200, 207205, 207219, 207242, 207249, 207250, 207296, 207315, 207316, 207328, 207331, 207370, 207373, 207375, 207376, 207377, 207378, 207382, 207383, 207385, 207386, 207387, 207398, 207461, 207462, 207466, 207468, 207470, 207501, 207502, 207503, 207506, 207508, 207516, 207518, 207564, 207565, 207566, 207567, 207568, 207571, 207572, 207575, 207580, 207594, 207597, 207601, 207621, 207622, 207624, 207625, 207626, 207635, 207636, 207639, 207643, 207644, 207645, 207710, 207711, 207712, 207713, 207714, 207715, 207716, 207717, 207718, 207743, 207744, 207745, 207748, 207749, 207750, 207751, 207752, 207753, 207755, 207756, 207783, 207799, 207800, 207801, 207802, 207803, 207805, 207809, 207814, 207907, 207908, 207909, 207910, 207911, 207912, 207913, 207921, 207963, 207972, 207996, 207997, 208002, 208029, 208045, 208085, 208089, 208096, 208105, 208122, 208143, 208144, 208146, 208148, 208149, 208216, 208217, 208235, 208239, 208240, 208241, 208245, 208274, 208275, 208279, 208280, 208281, 208290, 208291, 208292, 208293, 208338, 208339, 208342, 208343, 208344, 208345, 208400, 208485, 208552, 208632, 208665, 208701, 208720, 208809, 208832, 208833, 208834, 208835, 208836, 208837, 208840, 208865, 208868, 208875, 208885, 208919, 208920, 208921, 208922, 208924, 208925, 208926, 208927, 208928, 208929, 208930, 208931, 208932, 208942, 208943, 208944, 208945, 208946, 208947, 208948, 208949, 208950, 208952 208953 208954 208955 208956 208957 208958 208959 208960 208962 208963 208964 208965 208966 208967 208969 208970 208971 208973 208977 208980 208981 208982 208985 208987 208988 208989 208991 208993 208994 208995 208996 208997 208998 208999 209008 209010 209012 209013 209014 209015 209082 209156 209327 209453 209482 209489 209510 209511 209513 209514 209516 209517 209518 209520 209523 209524 209525 209534 209541 209542 209543 209544 209546 209549 209550 209551 209552 209553 209554 209555 209556 209558 209559 209560 209561 209562 209563 209564 209565 209566 209568 209569 209570 209571 209572 209573 209574 209575 209576 209588 209595 209596 209597 209598 209599 209600 209601 209602 209604 209606 209607 209608 209609 209610 209619 209620 209621 209623 209628 209629 209631 209632 209633 209639 209644 209645 209647 209648 209649 209650 209651 209681 209692 209705 209717 209719 209720 209721 209722 209723 209725 209726 209727 209728 209730 209731 209732 209741 209742 209744 209746 209750 209751 209762 209772 209773 209774 209779 209792 209794 209795 209801 209813 209814 209815 209828 209842 209848 209853 209855 209870 209882 209883 209884 209885 209886 209887 209888 209889 209890 209892 209893 209895 209896 209897 209900 209901 209902 209903 209905 209907 209908 209909 209910 209912 209915 209917 209918 209920 209921 209923 209928 209929 209930 209931 209932 209933 209935 209936 209937 209938 209939 209940 209942 209943 209944 209946 209947 209948 209949 209950 209951 209952 209953 209954 209956 209957 209958 209959 209960 209961 209962 209963 209964 209966 209967 209968 209969 209970 209971 209972 209973 209974 209976 209977 209978 209979 209981 209982 209983 209984 209985 209988 209989 209991 209993 209994 209995 209996 209997 209998 210001 210002 210003 210004 210005 210006 210007 210010 210011 210015 210016 210018 210032 210038 210046 210145 210146 210147 210151 210154 210155 210156 210157 210158 210159 210160 210161 210163 210164 210165 210166 210182 210184 210187 210192 210233 210267 210268 210269 210270 210296 210297 210298 210299 210300 210302 210318 210334 210335 210337 210341 210349 210361 210383 210386 210389 210407 210412 210428 210504 210519 210531 210546 210588 210606 210627 210629 210644 210646 210657 210660 210671 210689 210698 210699 210731 210733 210734 210735 210736 210737 210743 210764 210770 210776 210778 210782 210784 210790 210793 210818 210842 210846 210847 210848 210849 210850 210851 210852 210855 210856 210896 210924 210925 210927 210932 210933 210968 210974 210975 210976 210977 210978 210979 210982 210983 210997 211002 211015 211019 211020 211021 211022 211023 211024 211025 211028 211029 211030 211031 211032 211033 211034 211043 211044 211046 211047 211048 211049 211050 211052 211053 211054 211055 211057 211058 211059 211060 211061 211062 211063 211064 211065 211074 211075 211076 211078 211079 211080 211081 211082 211083 211085 211086 211087 211088 211089 211090 211092 211093 211094 211096 211097 211098 211099 211101 211104 211105 211106 211107 211109 211110 211111 211112 211113 211114 211115 211116 211118 211121 211122 211123 211124 211125 211126 211127 211128 211129 211133 211134 211135 211136 211137 211138 211139 211140 211141 211143 211144 211145 211146 211147 211148 211149 211150 211152 211157 211158 211159 211160 211161 211162 211163 211164 211165 211167 211168 211176 211177 211178 211179 211180 211182 211183 211186 211187 211188 211189 211190 211192 211193 211194 211197 211200 211201 211202 211204 211206 211207 211210 211223 211224 211226 211227 211230 211231 211232 211240 211241 211242 211244 211248 211249 211250 211252 211253 211254 211255 211267 211268 211270 211271 211272 211273 211274 211275 211276 211278 211279 211281 211282 211284 211472 211473 211474 211499 211561 211565 211567 211568 211569 211570 211571 211572 211573 211574 211575 211577 211578 211579 211580 211581 211582 211591 211592 211594 211597 211602 211607 211608 211610 211612 211613 211614 211615 211618 211619 211620 211621 211622 211623 211624 211625 211626 211799 211800 211801 211802 211803 211804 211805 211806 211808 211821 211823 211830 211834 211837 211842 211843 211844 211845 211847 211848 211849 211850 211851 211852 211853 211854 211855 211858 211859 211861 211862 211863 211864 211866 211867 211872 211879 211880 211881 211882 211885 211889 211892 211893 211894 211896 211897 211898 211899 211901 211922 211923 211928 211933 211935 211937 211938 211939 211940 211943 211944 211946 211957 211961 211962 211963 211965 211966 211972 211978 211980 211981 211983 211984 211985 211987 211989 211990 211991 211992 211993 211995 211996 211997 211998 211999 212000 212001 212004 212005 212007 212008 212009 212012 212014 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  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Curlin 6000 CMS Ambulatory Infusion Pump || Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
  • Manufacturer
    Zevex International, Inc.

Manufacturer

Zevex International, Inc.
  • Manufacturer Address
    Zevex International, Inc., 4314 Zevex Park Ln, Salt Lake City UT 84123
  • Manufacturer Parent Company (2017)
    Moog Inc
  • Source
    USFDA