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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Tenacore LLC: 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.

Agency Publication Date: April 2, 2021
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Affected Products

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

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

Product: Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410

Parts distributed between July 10, 2020 and January 22, 2021. Time stamp at bezel rear side shows 5 or 6 SO Numbers: 271111, 263873, 264442, 264890, 268606, 269930, 270760, 270936, 271211, 272860, 267603, 268936, 269258, 269291, 272496, 272225, 271408, 267392

Product Images

Photo - Rear side of the bezel - indicating location of the timestamp

Photo - Rear side of the bezel - indicating location of the timestamp

Photo –Top Upper Portion of Alaris Pump - indicating location of the ejector pin marks

Photo –Top Upper Portion of Alaris Pump - indicating location of the ejector pin marks

Photo – Backside of bezel assembly highlighting the bezel posts

Photo – Backside of bezel assembly highlighting the bezel posts

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87470
Status: Resolved
Manufacturer: Tenacore LLC
Manufactured In: United States
Units Affected: 2 products (474; 1494)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.