Class 1 Device Recall Tenacore serviced Alaris Pump Bezel Assembly

• Date Initiated by Firm: February 25, 2021
• Create Date: April 02, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1331-2021
• Recall Event ID: 87470
• 510(K)Number: K133532
• Product Classification: Pump, infusion - Product Code FRN
• Product: Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
• 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
• Recalling Firm/ Manufacturer: Tenacore LLC; 1525 E Edinger Ave; Santa Ana CA 92705-4907
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On 02/25/2021, Field Safety Corrective Action notifications were mailed to customers; customers were also notified via phone. The recalling firm provided the following services to customers: serviced infusion pumps, sold infusion pumps, and sold bezel repair parts. Customers were asked to do the following: 1. Review the serialized list of potentially impacted pumps and remove these devices from clinical use and immediately quarantine them until they can be inspected, and impacted parts are replaced, if necessary. Part customers were told to quarantine affected parts. 2. Inspect the potentially affected devices to determine if the impacted bezel repair part is installed. Refer to inspection instructions and a) identify the impacted Alaris 8100 Infusion Pump Module by serial number; b) Look from the top down for the ejector pin marks, c) If NO ejector pin marks are identified, this module requires bezel. Customers who were sold pumps can identify affected pumps through serial number alone. 3. Dealers and Distributors only: If potentially impacted pumps were sold, immediately identify, inspect and recall, if necessary, the potentially affected pumps. An electronic copy of a proposed field safety corrective action notice will be provided that can to be used for the facilities that may be using the potentially affected pumps. 4. Contact the recalling firm to schedule bezel repair part replacement. The impacted bezel repair part must be replaced before the pump can be returned to service. 5. Please immediately share this field safety corrective action notification with all necessary parties within your organization to ensure that they are also aware of this action. Notify end user customers. 6. Complete and return the customer response form. Contact Quality Assurance at 714-371-9919 or Quality@Tenacore.com to schedule replacement of the impacted part.
• Quantity in Commerce: 474
• Distribution: US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = CAREFUSION 303, INC.