Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repa...
FDA Device Recall #Z-1331-2021 — Class I — February 25, 2021
Recall Summary
| Recall Number | Z-1331-2021 |
| Classification | Class I — Serious risk |
| Date Initiated | February 25, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Tenacore LLC |
| Location | Santa Ana, CA |
| Product Type | Devices |
| 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
Lot / 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
Other Recalls from Tenacore LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1332-2021 | Class I | Alaris Infusion Pump 8100 Bezel (plastic piece ... | Feb 25, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.