Z-1331-2021 Class I Terminated

Recalled by Tenacore LLC — Santa Ana, CA

Recall Details

Product Type
Devices
Report Date
April 14, 2021
Initiation Date
February 25, 2021
Termination Date
August 5, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
474

Product Description

Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part

Reason for Recall

Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

Distribution Pattern

US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA

Code Information

Serviced/Repaired between July 10, 2020 and February 18, 2021 with Serial Numbers: 14789900, 14426738, 14426703, 9856983, 4038121, 9586652, 12421654, 4035910, 4037310, 4040396, 12653566, 13979989, 13410610, 12389912, 12358178, 13040916, 12390023, 12534649, 4038582, 12533626, 12389988, 13004789, 13040564, 9856969, 4040071, 12437067, 404843, 13410468, 12934959, 12534587, 4047842, 12436857, 12533639, 405074, 4037334, 12935440, 12533768, 4040123, 14020832, 14021684, 15750839, 15678618, 14021329, 13662844, 13663177, 13662997, 13663187, 13662877, 13660363, 13663214, 2264, 13662949, 13663037, 13662922, 13662988, 13658436, 13663064, 13608884, 13662998, 13663030, 13662833, 13663172, 13663130, 13194673, 13194565, 14855715, 14855832, 13553167, 13580782, 14708466, 13184675, 14363051, 14286744, 13177343, 13178014, 13159994, 13184528, 14351419, 13851507, 13184537, 13184590, 13184819, 14351436, 9929089, 13178138, 13322498, 4005563, 4007549, 13428655, 13428782, 14152325, 13744468, 13744594, 13744988, 12664724; Serviced/Repaired and Sold between July 10, 2020 and February 18, 2021 with Serial Numbers And No Bezel Ejector Pin Marks: 13957538, 12607700, 13061038, 13060510, 13069763, 13058882, 13061013, 13058475, 13061211, 13070091, 13059253, 13060693, 13070776, 13058970, 13060695, 13060750, 13060747, 13058622, 13061106, 13058766, 13056808, 13060877, 12667934, 13325198, 13495778, 12876247, 13107958, 13397686, 17569459, 13195488, 12766437, 14120311, 14114052, 14117289, 14124021, 14118083, 14122300, 14110517, 14120512, 14120591, 13058787, 13058835, 13070111, 1038662, 13058798, 14341505, 14321905, 14320652, 14321540, 14321606, 14321978, 14322006, 14321588, 14321576, 14321312, 14321218, 13058911, 13070275, 13058702, 13405025, 13061007, 13058778, 13057352, 13058590, 13066565, 13059200, 13058228, 13057843, 13059032, 13060749, 13212623, 13058009, 13057878, 13058596, 23060697, 23069352, 13060981, 13070780, 14201235, 13001035, 13405284, 13060796, 14200197, 13405142, 13058715, 14201234, 13212933, 13405301, 13125512, 13058523, 13060667, 13057898, 12580033, 13512515, 14064847, 13219417, 13220334, 14065848, 13219944, 13335903, 14061430, 14061166, 14064996, 13211175, 13208436, 13361187, 12869285, 12806211, 12589587, 13141802, 12764498, 4109662, 13219531, 13858686, 12672740, 14403241, 14070352, 12331567, 13066493, 13067292, 13070497, 13059192, 13069563, 15681457, 15037681, 15088020, 15344885, 13212921, 13069796, 13060558, 13067951, 13213139, 14357792, 14201398, 13404893, 13547403, 13057223, 13058307, 13069450, 13212589, 13058141, 13213318, 13061043, 13212706, 13205949, 13069585, 13205982, 13060863, 13057951, 13057946, 13070074, 13058909, 13069762, 13059031, 13060969, 12723827, 13061205, 13070212, 13059015, 12971125, 13058762, 13058855, 13061053, 13067233, 13067281, 13058754, 13060815, 13058799, 15037688, 12971413, 13066932, 13061174, 13067412, 13060958, 14308044, 14316727, 13976037, 13058826, 13060593, 13058794, 13405132, 13070112, 13058533, 14200709, 13060807, 13060653, 13060545, 13060895, 13061020, 13058561, 13060692, 13403978, 13070244, 13061225, 13070772, 13061188, 13058697, 13058800, 10938662, 13527491, 13069640, 13812730, 13068029, 15088022, 13070185, 13058050, 13061072, 13213069, 13058144, 13213097, 13070201, 13405352, 13060861, 13061176, 13219744, 13059183, 13125707, 13058861, 13058813, 13212585, 13069782, 12679928, 13070228, 13058560, 13060949, 13069349, 13739424, 14716904, 9952646, 9952897, 12666056, 12752058, 12752057, 12752008, 14321934, 14321229, 14321224, 14340821, 14337759, 14321605, 14320879, 13184045, 13212594, 13059196, 13057563, 13126061, 13059289, 13061161, 13058532, 13058468, 13058897, 13060706, 13055346, 13057517, 13059267, 14201336, 14440045, 13072976, 13058760, 13056721, 13061224, 13070731, 13069347, 13070116, 13060810, 13060974, 13058848, 13061051, 13061052, 13058002, 13124723, 13061131, 13015864, 13057312, 13060973, 13060655, 15035694, 13061078, 13058174, 13058918, 13408986, 13404355, 13746327, 15086257, 13070222, 14440148, 13070249, 13144661, 12606642, 12527638, 1385888, 13070816, 13060514, 13060659, 13058700, 13125847, 13058873, 13058834, 13060813, 13059228, 13060661, 13060829, 13059218, 13060912, 13058784, 13212513, 13060893, 13057320, 13060559, 13070817, 13212268, 13057960, 13059182, 13058880, 13059030, 13058749, 15087880, 13059249, 13060660, 13420636, 13060871, 13123029, 13058910, 13067998, 13069379, 13060534, 13061004, 13527473, 13405092, 13058789, 13059235, 13058626, 13058309, 13066447, 15037677, 13061186, 13058877, 13066727, 13060782, 13132330, 13060713, 13058802, 13058795, 13060997, 13060865, 13059016, 13827357, 13058627, 13061012, 13070778, 13404836, 13219964, 1306771, 13059179, 13060805, 13060712, 13061018, 13212815, 13058796, 13060536, 13058849, 13058546, 13060795, 13405172, 14200938, 13059172, 13070510, 15037700, 13404919, 13058913, 13058720, 13070186, 13069453, 13067771, 13123028, 13527627, 13059014, 13061191, 13212724