Z-1477-2022
FDA Device Recall #Z-1477-2022 — Class II — June 6, 2022
Recall Summary
| Recall Number | Z-1477-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 6, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - SPT |
| Location | Waukegan, IL |
| Product Type | Devices |
| Quantity | 28745 units |
Reason for Recall
Kits contain leaking bottles of isopropyl alcohol
Distribution Pattern
US Nationwide distribution.
Lot / 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;
Other Recalls from MEDLINE INDUSTRIES, LP - SPT
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1470-2022 | Class II | Medline Convenience kits labeled as follows: a... | Jun 6, 2022 |
| Z-1471-2022 | Class II | Medline convenience kits: a. VENOUS ACCESS PAC... | Jun 6, 2022 |
| Z-1475-2022 | Class II | Medline Convenience kits labeled as: a. WET SK... | Jun 6, 2022 |
| Z-1476-2022 | Class II | Medline Custom procedural kits labeled as follo... | Jun 6, 2022 |
| Z-1474-2022 | Class II | Medline Convenience kits labeled as: a. MAJOR ... | Jun 6, 2022 |
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.