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U.S. Department of Health and Human Services

Class 2 Device Recall Medline convenience kits

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  Class 2 Device Recall Medline convenience kits see related information
Date Initiated by Firm June 06, 2022
Create Date July 27, 2022
Recall Status1 Open3, Classified
Recall Number Z-1477-2022
Recall Event ID 90516
Product Classification Orthopedic tray - Product Code OJH
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/
1170 S Northpoint Blvd
Waukegan IL 60085-6757
For Additional Information Contact Kassandra Cotner
Manufacturer Reason
for Recall
Kits contain leaking bottles of isopropyl alcohol
FDA Determined
Cause 2
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.