Class 2 Device Recall Medline convenience kits

• Date Initiated by Firm: June 06, 2022
• Create Date: July 27, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1477-2022
• Recall Event ID: 90516
• Product Classification: Orthopedic tray - Product Code OJH

Product

• Code Information: a. Model CDS981510J, Lot Numbers: 22BDB532; b. Model CDS984260I, Lot Numbers: 22CBM678, 22CBM679, 21FBJ127, 21GBV813, 21KBA497; c. Model CDS984263L, Lot Numbers: 22DBD966, 22CBV297, 21GBV822; c. Model DYNJ906469D, Lot Numbers: 22DDA747, 22DDA652, 22CDC430; c. Model DYNJ908097, Lot Numbers: 22ABN864, 22BBU902, 22BBX706, 21IBO640; c. Model DYNJ906469B, Lot Numbers: 21EDA002, 21HDB515; d. Model DYKMBNDL141, Lot Numbers: 22ABL303, 22BBR667, 22CBV519, 21GBJ360, 21GBO489, 21IBJ315, 21IBK151, 21VBB503, 21CBJ601, 21EBM705, 21FBF908; e. Model DYKMBNDL143, Lot Numbers: 22ABN016, 21KBA482, 21CBS017, 21CBT399; f. Model DYKMBNDL144, Lot Numbers: 22CLA771, 21LLA651, 22BLA947, 21DLA534, 21FLA052, 21GLA640, 21GLA871, 21HLA178, 21HLA660, 21ILA240, 21JLA461, 21KLB158, 21LLA431; g. Model DYKMBNDL145A, Lot Numbers: 22ABL304, 21GBA981, 21GBJ361, 21JBQ909; h. Model DYKMBNDL160A, Lot Numbers: 22DBD150, 21LBX974, 22CBT054, 21FBO540, 21GBB011, 21GBR032, 21HBO270, 21IBU144, 21JBJ233, 21LBP525, 21CBM831, 21EBQ761 i. Model DYKMBNDL5A, Lot Numbers: 22OBI934, 22DBE579, 22ABG023, 22CBX205, 21KBC488, 21LBD743, 21EBG521; j. Model DYNJ44044B, Lot Numbers: 21GBO678, 21GBO688; k. Model DYNJ46505I, Lot Numbers: 21KBK061; l. Model DYNJ46531M, Lot Numbers: 22DBG277, 22DBL697, 22OBB278, 22OBB279, 21JBQ708, 21KBQ426; m. Model DYNJ46533G, Lot Numbers: 21JBH068; n. Model DYNJ56778F, Lot Numbers: 21EBC732; n. Model DYNJ904660D, Lot Numbers: 22BBO231, 22CBB857, 22CBJ576, 21FBM621, 21GBQ436, 21KBD961, 21KBZ632, 21LBI692, 21DBU774; n. Model DYNJ906666J, Lot Numbers: 22DDA329; n. Model DYNJ908094, Lot Numbers: 22DBG252, 22CLA375, 21IBS818, 21KBF456; n. Model DYNJ905337A, Lot Numbers: 21GBB871, 21IBL645, 21VBC385, 21FBE200; n. Model DYNJ906666B, Lot Numbers: 21BDB196; n. Model DYNJ906666C, Lot Numbers: 21EDB515, 21EDB761; n. Model DYNJ906666F, Lot Numbers: 21GDD196, 21IDA250; n. Model DYNJ906666G, Lot Numbers: 21LDB106, 21KDC158; n. Model DYNJ906666I, Lot Numbers: 22CDB427, 22BDC525; n. Model DYNJ907974, Lot Numbers: 22BBE746, 22BBE747, 21GBV726, 21HBQ122; n. Model DYNJ908094, Lot Numbers: 22DBG252, 22CLA375, 21IBS818, 21KBF456; o. Model DYNJ56777F, Lot Numbers: 20HBN260A, 21EBQ733; o. Model DYNJ904659D, Lot Numbers: 22CBS374, 21FBN812, 21HBA553, 21LBD420, 21LBH646, 21LBV345, 21CBP615, 21EBI532; o. Model DYNJ906665B, Lot Numbers: 21BDB189, 21EDA274; o. Model DYNJ906665C, Lot Numbers: 21HDC570; o. Model DYNJ906665D, Lot Numbers: 21IDA023; o. Model DYNJ906665F, Lot Numbers: 22ADB711, 22ADA208, 21JDB148, 21JDC276; o. Model DYNJ906665G, Lot Numbers: 22CDC258; p. Model DYNJ46552L, Lot Numbers: 22CDC208, 22BDA822, 22BDA555, 21LDB169, 21LDA176, 21KDA060; p. Model DYNJ46552K, Lot Numbers: 21IDA127, 21IDB162; q. Model DYNJ52088B, Lot Numbers: 22DBG013, 22DBG387; r. Model DYNJ52094C, Lot Numbers: 22DBG066, 22BBJ197; s. Model DYNJ54977A, Lot Numbers: 21IBU124, 21KBR731, 21LBT526, 21FBG086; t. Model DYNJ56776J, Lot Numbers: 22DDA841, 21HDA550, 21HDC632, 21IDC161; t. Model DYNJ56776I, Lot Numbers: 21DDB678; u. Model DYNJ57243D, Lot Numbers: 22CBT485, 21FBL491, 21GBN005, 21IBS903, 21JBS585, 21KBJ346, 21LBR681; v. Model DYNJ58255C, Lot Numbers: 22DDB736; v. Model DYNJ58255B, Lot Numbers: 21KDB706, 21HDA730, 21IDA681, 21IDC148; w. Model DYNJ60943, Lot Numbers: 21GBR739; x. Model DYNJ66243, Lot Numbers: 22ABP071, 22OBE350, 21GBB321, 21IBL773, 21JBW186, 21KBA808, 21DBG896; y. Model DYNJ46534L, Lot Numbers: 22DDA743, 22CDB845, 22CDB494, 22BDC451; y. Model DYNJ46534K, Lot Numbers: 22ADA319, 21JDA828, 21JDB061, 21JDB675; z. Model DYNJ46548I, Lot Numbers: 22DBJ066, 22BBU847, 21IBX763; aa. Model DYNJ68353B, Lot Numbers: 22DLA243, 21KLA555, 22CLA373, 21HLA293, 21ILA673, 21JLA493, 21JLB140; bb. Model DYNJ69607, Lot Numbers: 22CBW013, 21HBN622; cc. Model DYNJ69690, Lot Numbers: 22CBL518, 21JBP298; dd. Model DYNJ900207L, Lot Numbers: 21IBV604, 21KBI371; ee. Model DYNJ900606F, Lot Numbers: 22CDC248.22BDA983, 21KDC590, 21EDB470, 21FDC640, 21HDB359, 21IDA806; ff. Model DYNJ900624F, Lot Numbers: 22CDB875, 22BDA163, 21LDA018, 21FDB238, 21GDC607, 21IDB708 gg. Model DYNJ902420D, Lot Numbers: 21EBC687; gg. Model DYNJ902420G, Lot Numbers: 21IBJ219, 21IBJ222; hh. Model DYNJ904078I, Lot Numbers: 22DBH262, 22DBI411, 21LBJ716; hh. Model DYNJ904078G, Lot Numbers: 21GBP343, 21HBM052, 21JBM714; ii. Model DYNJ904082J, Lot Numbers: 22OBA523, 22BBR271; jj. Model DYNJ904609C, Lot Numbers: 21DBP376; jj. Model DYNJ904609D, Lot Numbers: 22BBV405, 21GBE713, 21HBJ103, 21HBJ106, 21IBU496, 21KBL630; kk. Model DYNJ904611D, Lot Numbers: 22BDC256, 21LDB071, 21FDB298, 21GDC590, 21JDB217; ll. Model DYNJ904656F, Lot Numbers: 22DBL456, 21FBO730, 21FBO731, 21IBV575, 21KBA394, 21KBE048; ll. Model DYNJ904656D, Lot Numbers: 21CBP614; mm. Model DYNJ904657D, Lot Numbers: 22CBB993, 21FBN631, 21FBN769, 21GBK450, 21JBX795, 21LBM310, 21DBA575, 21FBC600; mm. Model DYNJ904945A, Lot Numbers: 21GBA021, 21HBC615, 21EBI304, 21FBH239; nn. Model DYNJ904658C, Lot Numbers: 22OBG849, 22OBF802, 21FBI651, 21FBO736, 21IBL939, 21LBI664; oo. Model DYNJ904661D, Lot Numbers: 22OBG856, 22OBB277, 22OBB280, 21GBC720, 21IBU503, 21LBQ921, 21DBU712, 21FBF890; pp. Model DYNJ904662D, Lot Numbers: 22CLA847, 22OBG841, 22CLA235, 22OBC072, 21FBJ147, 21GBS644, 21JBM726, 21LBQ894; qq. Model DYNJ904663D, Lot Numbers: 22OBM654, 22CBB864, 22CBB865, 21GBB833, 21JBF871, 21KBZ663; qq. Model DYNJ906274C, Lot Numbers: 22CBX167; rr. Model DYNJ904664D, Lot Numbers: 22DBC199, 22NBA861, 21GBU921, 21KBF386, 21LBH673, 21DBU804, 22CBX167; ss. Model DYNJ905118B, Lot Numbers: 22DDB160, 22CDC407, 22BDA170, 21KDC069, 21KDB034, 21DDB967, 21GDA248, 21IDB331; tt. Model DYNJ905156L, Lot Numbers: 21CBQ685, 21EBI411; uu. Model DYNJ905229D, Lot Numbers: 22BBW371, 22CBU928, 21FBO791, 21HBF318, 21VBB489, 21LBN462, 21CBR886, 21EBH518, 21EBI594; vv. Model DYNJ905286C, Lot Numbers: 22ABG618, 21GBA953, 21KBG240; vv. Model DYNJ905286D, Lot Numbers: 22DBH763, 22DBI830, 22NBB154; ww. Model DYNJ905336A, Lot Numbers: 21FBK203, 21FBE884; ww. Model DYNJ908095, Lot Numbers: 22CBG102, 22CBO113, 21IBC036, 21KBP600; xx. Model DYNJ905382A, Lot Numbers: 22ABP666, 22ABP667, 21IBD365, 21JBM625, 21DBH556, 21DBP137; yy. Model DYNJ905414A, Lot Numbers: 22ABS958, 22BBW420, 21FBT745, 21IBM917, 21JBU311, 21DBE171; zz. Model DYNJ907843, Lot Numbers: 21GBO973, 21IBR045; zz. Model DYNJ907843A, Lot Numbers: 22DBM455, 22DBT352, 21LBF065; aaa. Model DYNJ905724C, Lot Numbers: 22AME838, 22AMD320, 22AMB449, 22CMH063, 21IMF860; bbb. Model DYNJ905732C, Lot Numbers: 22AME574, 22CMH111, 21HMA825, 21JMF127, 21JMI200, 21KMB987; ccc. Model DYNJ905858B, Lot Numbers: 22OBM385, 22ABC154, 21FBL884, 21FBS431, 21FBS432, 21DBI941; ddd. Model DYNJ906005B, Lot Numbers: 22BBG458, 22NBE578, 21GBJ24, 21HBM969, 21JBD171, 21LBV278; eee. Model DYNJ906006B, Lot Numbers: 22CLA401, 21GBL075, 21GBL333, 21IBJ328, 21LBD394, 21LBV260, 21LBV261, 21DBA640, 21EBB754; fff. Model DYNJ906007B, Lot Numbers: 22DBF580, 21IBV573, 21JBF902, 21LBV302; ggg. Model DYNJ906008C, Lot Numbers: 21HBE851, 21CBQ655, 21CBU643, 21DBE137, 21DBU755, 21FBC642; ggg. Model DYNJ906008D, Lot Numbers: 21LBY271, 21IBP858, 21KBF368, 21LBI666; hhh. Model DYNJ906009B, Lot Numbers: 22BBS089, 22NBE583, 21GBS642, 21IBV597, 21LBV287, 21FBC697; iii. Model DYNJ906010B, Lot Numbers: 22BBL321, 21LBX216; jjj. Model DYNJ906200A, Lot Numbers: 22DBS793, 22BBD209, 22NBC273, 22NBE587, 21FBP736, 21JBV949, 21KBR422, 21DBP131, 21FBE186, 21FBE337; kkk. Model DYNJ906204, Lot Numbers: 22BBB110, 22BBE007, 21GBH370, 21HBR379, 21IBD876, 21KBA381, 21KBO548, 21CBU212, 21EBH550; lll. Model DYNJ906239B, Lot Numbers: 22BBI952, 21WBA947; mmm. Model DYNJ906241A, Lot Numbers: 22OBM619, 21LBD641, 21LBS726; nnn. Model DYNJ906566A, Lot Numbers: 21GBC277, 21IBG793, 21CBQ783, 21EBO607; nnn. Model DYNJ906566B, Lot Numbers: 22OBL728, 22ABV164, 22BBD205, 21VBC506, 21LBR723; ooo. Model DYNJ906567A, Lot Numbers: 21CBQ786; ooo. Model DYNJ906567B, Lot Numbers: 21HBM026, 21IBI538, 21JBQ492; ooo. Model DYNJ906567C, Lot Numbers: 22DBL568, 22ABD965, 22BBN260, 22CBG822; ppp. Model DYNJ906612G, Lot Numbers: 22DDA825, 22BDC349, 21HDB450, 21IDB900; ppp. Model DYNJ906612I, Lot Numbers: 22DDC352; qqq. Model DYNJ906613G, Lot Numbers: 22CDB106, 22ADA486, 21IDB055, 21JDB115; qqq. Model DYNJ906613I, Lot Numbers: 22CDC140; rrr. Model DYNJ907971, Lot Numbers: 22OBM310, 22BBD926, 21GBR276, 21IBJ245, 21JBS128; sss. Model DYNJ907973, Lot Numbers: 22CLA845, 22ALA203, 22CLA272, 21ILA914; ttt. Model DYNJ905243C, Lot Numbers: 22ABI725, 22CBP426, 21GBE872, 21HBM972, 21IBU504, 21FBA009; uuu. Model DYNJ906938, Lot Numbers: 22OBI072, 22OBI470, 22ABI222, 22BBZ184, 21HBN907, 21JBU235; vvv. Model DYNJ908078, Lot Numbers: 21IBF024; www. Model DYNJ908091, Lot Numbers: 21HBU469, 21IBS817; www. Model DYNJ908091A, Lot Numbers: 22DBD986, 22ABR911, 22CBW646, 21LBR725; xxx. Model DYNJ907968, Lot Numbers: 22ALA893, 22BLA529, 22CLA271, 21ILA992; yyy.Model DYNJ908259, Lot Numbers: 22BBV384, 21KBP466; zzz. Model DYNJ908263, Lot Numbers: 22ABS977; aaaa. Model DYNJ907143D, Lot Numbers: 22OBH810, 22MBA657, 21IBS813, 21KBL376; bbbb. Model DYNJ907149, Lot Numbers: 21JBW917; cccc. Model DYNJ907152, Lot Numbers: 22BBM537, 21GBC602, 21VBA112; dddd. Model DYNJ907372, Lot Numbers: 21GLB099, 21JLA456, 21JLB164, 21KLA037, 21KLA520; eeee. Model DYNJ907467, Lot Numbers: 22ABC205, 21LBV086; ffff. Model DYNJ908075, Lot Numbers: 21JBS075, 21KBZ493; ffff. Model DYNJ908075A, Lot Numbers: 22BBS913; gggg. Model DYNJ908076, Lot Numbers: 22DBP019, 22DBT978, 21VBA176, 21KBO313, 21KBP617; hhhh. Model DYNJ907572, Lot Numbers: 21DBA528, 21EBC603; hhhh. Model DYNJ907572A, Lot Numbers: 22BBI828, 22BBW390, 21FBK984, 21GBA875, 21GBL066, 21LBT087; iiii. Model DYNJ907951, Lot Numbers: 22CLA592, 22CLA902, 21LLB012, 22ALA807, 21HLA276, 21HLA493, 21HLA648, 21JLA343, 21JLB059; jjjj. Model DYNJ907952, Lot Numbers: 22CLA593, 22ALA669, 22BLB113, 22CLA060, 21ILA042, 21ILA075, 21ILA219, 21ILA421, 21JLA899, 21KLA142, 21KLA188; kkkk. Model DYNJ908248, Lot Numbers: 22ALA131, 21LLA172, 21LLA381; llll.Model DYNJ907969, Lot Numbers: 22OBK888, 22BBQ817, 22OBF827, 21GBV778, 21IBP836, 21LBX214; mmmm. Model DYNJ908322, Lot Numbers: 22ABK902, 21LBH210; nnnn. Model DYNJC9108P, Lot Numbers: 22DBL813, 22NBD148, 21GBN201, 21IBT316; oooo. Model DYNJC9109Q, Lot Numbers: 22OBH183, 21FBJ984, 21IBG621, 21JBZ253, 21LBD712; pppp. Model DYNJ908033, Lot Numbers: 22AMB293, 21KMI441, 22CMC584, 22CMG968, 21JMA790
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - SPT; 1170 S Northpoint Blvd; Waukegan IL 60085-6757
• For Additional Information Contact: Kassandra Cotner; 866-775-6072
• Manufacturer Reason for Recall: Kits contain leaking bottles of isopropyl alcohol
• FDA Determined Cause: Under Investigation by firm
• Action: The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations.
• Quantity in Commerce: 28745 units
• Distribution: US Nationwide distribution.
• 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.