Z-2303-2023 Class II Ongoing

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYNJ53438A, DYNJ53610C, DYNJ53995G, DYNJ56791A, DYNJ56791B, DYNJ57490A, DYNJ58608, DYNJ58681A, DYNJ58681B, DYNJ58710, DYNJ61325A, DYNJ61325B, DYNJ61528, DYNJ62399A, DYNJ65160, DYNJ66356, DYNJ66356A, DYNJ66356B, DYNJ66356C, DYNJ66356D, DYNJ66577, DYNJ68492A, DYNJ68492B, DYNJ68492C, DYNJ68492D, DYNJ68863, DYNJ68863A, DYNJ68880, DYNJ80599, DYNJ81626, DYNJ82016, DYNJ82104, DYNJ82144, DYNJ82769, DYNJ82769A, DYNJ83146; b. VASCULAR PACK CHRG, Model Number: DYNJ59778A, DYNJ59778B; c. VASCULAR PACK GWV, Model Number: DYNJ59245; DYNJ59245A; d. VASCULAR PACK MH-LF, Model Number: DYNJ39866B, DYNJ39866C; e. VASCULAR PACK SHD, Model Number: DYNJ68404; f. VASCULAR PACK-LF, Model Number: DYNJ0250564O, DYNJ0250564P, DYNJ0373040N, DYNJ0493141G, DYNJ0493141I, DYNJ0493141J, DYNJ0871182AC, DYNJ0901358I, DYNJ0901358J, DYNJ0901358K, DYNJ53475F, DYNJ53684A, PHS400047N, PHS400047O; g. VASCULAR STENT INOVA, Model Number: DYNJ906440A; h. VASCULAR TRAY, Model Number: DYNJ56858; i. VASCULAR/OR ANGIO, Model Number: DYNJ905079F; j. VASCULAR-LF, Model Number: DYNJ900714B, DYNJ900714C; k. VEIN ABLATION EXCISION ASC, Model Number: DYNJ52586B; l. VEIN ABLATION & EXCISION ASC, Model Number: DYNJ52586, DYNJ52586A, DYNJ52586B; m. VEIN ABLATION KIT, Model Number: DYNJ69272A; n. VEIN ABLATION PACK, Model Number: DYNJ62889; o. VEIN ABLATION TRAY W/CHLOR, Model Number: DYNJ64396; p. VEIN AND LASER PACK, Model Number: DYNJ49874; q. VEIN CENTER PACK, Model Number: DYNJ52123; r. VEIN CLINIC, Model Number: DYNJ68667; s. VEIN CLOSURE PACK, Model Number: DYNJ35586G, DYNJ39408F, DYNJ65189B; t. VEIN CLOSURE TRAY, Model Number: DYNJ44737B; u. VEIN KIT, Model Number: DYNJ57047; v. VEIN LIGATION, Model Number: DYNJ64190; w. VEIN OHH, Model Number: DYNJ65560A; x. VEIN PACK, Model Number: DYNJ21949J, DYNJ39005B, DYNJ39889, DYNJ48493, DYNJ48907F, DYNJ50785, DYNJ52098, DYNJ52993A, DYNJ53160, DYNJ53160A, DYNJ54153B, DYNJ55268, DYNJ55462A, DYNJ55514A, DYNJ55849A, DYNJ56624, DYNJ56724A, DYNJ56724B, DYNJ57512, DYNJ57835, DYNJ57917, DYNJ58063, DYNJ58609, DYNJ59151F, DYNJ59662B, DYNJ59662D, DYNJ59677A, DYNJ59681A, DYNJ61540C, DYNJ63823, DYNJ64282, DYNJ64471A, DYNJ65579, DYNJ66154, DYNJ66743A, DYNJ68749, DYNJ69091, DYNJ80199A, DYNJ80199B, DYNJ80868, DYNJ83147; y. VEIN PACK II, Model Number: DYNJ66427; z. VEIN PACK-LF, Model Number: DYNJ66271A, DYNJ66271C; aa. VEIN PROCEDURE, Model Number: DYNJ65342A; bb. VEIN PROCEDURE PACK, Model Number: DYNJ38264D, DYNJ62038A, DYNJ64909; cc. VEIN SPECIALISTS PACK, Model Number: DYNJ53616A; dd. VEIN TRAY, Model Number: DYNJ57003, DYNJ62829A; ee. VENOUS ABLATION, Model Number: DYNJ50227C; ff. VENOUS ACCESS ACCESSORY PACK, Model Number: DYNJ61010A; gg. VENOUS ACCESS PACK, Model Number: DYNJ44421D; hh. VIRC STROKE PACK, Model Number: DYNJ83461; ii. VNUS, Model Number: CDS984292I; jj. VNUS CLOSURE, Model Number: DYNJ66076; kk. VNUS VASCULAR PACK, Model Number: DYNJ66445; ll. WA VASCULAR PACK-LF, Model Number: DYNJ33612G

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ22350K, UPC Number: 019348956435; Model Number: DYNJ22350L, UPC Number: 019348944525; Model Number: DYNJ22676J, UPC Number: 019348956435; Model Number: DYNJ23445F, UPC Number: 019532715035; Model Number: DYNJ31902L, UPC Number: 019348956435; Model Number: DYNJ31902M, UPC Number: 019532729658; Model Number: DYNJ39432I, UPC Number: 019348933454; Model Number: DYNJ39432J, UPC Number: 019532710115; Model Number: DYNJ39432K, UPC Number: 019532730509; Model Number: DYNJ41625B, UPC Number: 088994293420; Model Number: DYNJ46246A, UPC Number: 088994258496; Model Number: DYNJ53438A, UPC Number: 019348965302; Model Number: DYNJ53610C, UPC Number: 019348930032; Model Number: DYNJ53995G, UPC Number: 019532707376; Model Number: DYNJ56791A, UPC Number: 019348959411; Model Number: DYNJ56791B, UPC Number: 019532704567; Model Number: DYNJ57490A, UPC Number: 019348964199; Model Number: DYNJ58608, UPC Number: 088994287195; Model Number: DYNJ58681A, UPC Number: 088827779848; Model Number: DYNJ58681B, UPC Number: 019532729337; Model Number: DYNJ58710, UPC Number: 088994288085; Model Number: DYNJ61325A, UPC Number: 019348979445; Model Number: DYNJ61325B, UPC Number: 019532709784; Model Number: DYNJ61528, UPC Number: 019348957898; Model Number: DYNJ62399A, UPC Number: 019348925026; Model Number: DYNJ65160, UPC Number: 019348925092; Model Number: DYNJ66356, UPC Number: 019348934445; Model Number: DYNJ66356A, UPC Number: 019348983939; Model Number: DYNJ66356B, UPC Number: 019348994135; Model Number: DYNJ66356C, UPC Number: 019348999105; Model Number: DYNJ66356D, UPC Number: 019532706029; Model Number: DYNJ66577, UPC Number: 019348936096; Model Number: DYNJ68492A, UPC Number: 019348991395; Model Number: DYNJ68492B, UPC Number: 019532703330; Model Number: DYNJ68492C, UPC Number: 019532720566; Model Number: DYNJ68492D, UPC Number: 019532734221; Model Number: DYNJ68863, UPC Number: 019348984540; Model Number: DYNJ68863A, UPC Number: 019532702645; Model Number: DYNJ68880, UPC Number: 019348984772; Model Number: DYNJ80599, UPC Number: 019532705334; Model Number: DYNJ81626, UPC Number: 019532712706; Model Number: DYNJ82016, UPC Number: 019532716359; Model Number: DYNJ82104, UPC Number: 019532717108; Model Number: DYNJ82144, UPC Number: 019532717803; Model Number: DYNJ82769, UPC Number: 019532720722; Model Number: DYNJ82769A, UPC Number: 019532735023; Model Number: DYNJ83146, UPC Number: 019532723568. b. Model Number: DYNJ59778A, UPC Number: 019348959858; Model Number: DYNJ59778B, UPC Number: 019348969592. c. Model Number: DYNJ59245, UPC Number: 088827776727; Model Number: DYNJ59245A, UPC Number: 019532703914. d. Model Number: DYNJ39866B, UPC Number: 088994270504; Model Number: DYNJ39866C, UPC Number: 019532717634. e. Model Number: DYNJ68404, UPC Number: 019348983069. f. Model Number: DYNJ0250564O, UPC Number: 019348956435; Model Number: DYNJ0250564P, UPC Number: 019532708884; Model Number: DYNJ0373040N, UPC Number: 019348987387; Model Number: DYNJ0493141G, UPC Number: 019348956435; Model Number: DYNJ0493141I, UPC Number: 019348956435; Model Number: DYNJ0493141J, UPC Number: 019348992622; Model Number: DYNJ0871182AC, UPC Number: 019532733085; Model Number: DYNJ0901358I, UPC Number: 019348956435; Model Number: DYNJ0901358J, UPC Number: 019348956435; Model Number: DYNJ0901358K, UPC Number: 019532734322; Model Number: DYNJ53475F, UPC Number: 019348942486; Model Number: DYNJ53684A, UPC Number: 019348938687; Model Number: PHS400047N, UPC Number: 019348996690; Model Number: PHS400047O, UPC Number: 019532712350. g. Model Number: DYNJ906440A, UPC Number: 019348931287. h. Model Number: DYNJ56858, UPC Number: 088994268907. i. Model Number: DYNJ905079F, UPC Number: 019532720900. j. Model Number: DYNJ900714B, UPC Number: 019348922643; Model Number: DYNJ900714C, UPC Number: 019348995136. k. Model Number: DYNJ52586B, UPC Number: 019532721211. l. Model Number: DYNJ52586, UPC Number: 088994229774; Model Number: DYNJ52586A, UPC Number: 019348949439; Model Number: DYNJ52586B, UPC Number: 019532721211. m. Model Number: DYNJ69272A, UPC Number: 019532701580. n. Model Number: DYNJ62889, UPC Number: 019348969667. o. Model Number: DYNJ64396, UPC Number: 019348981050. p. Model Number: DYNJ49874, UPC Number: 088827789060. q. Model Number: DYNJ52123, UPC Number: 088994224214. r. Model Number: DYNJ68667, UPC Number: 019348983731. s. Model Number: DYNJ35586G, UPC Number: 019348966323; Model Number: DYNJ39408F, UPC Number: 019348969283; Model Number: DYNJ65189B, UPC Number: 019348943314. t. Model Number: DYNJ44737B, UPC Number: 019348935171. u. Model Number: DYNJ57047, UPC Number: 088994271048. v. Model Number: DYNJ64190, UPC Number: 019348979335. w. Model Number: DYNJ65560A, UPC Number: 019348939718. x. Model Number: DYNJ21949J, UPC Number: 088994212841; Model Number: DYNJ39005B, UPC Number: 019348956435; Model Number: DYNJ39889, UPC Number: 088438979693; Model Number: DYNJ48493, UPC Number: 088827759997; Model Number: DYNJ48907F, UPC Number: 088994252942; Model Number: DYNJ50785, UPC Number: 088994210530; Model Number: DYNJ52098, UPC Number: 088994223706; Model Number: DYNJ52993A, UPC Number: 019348936103; Model Number: DYNJ53160, UPC Number: 088994238558; Model Number: DYNJ53160A, UPC Number: 019348974565; Model Number: DYNJ54153B, UPC Number: 088994271442; Model Number: DYNJ55268, UPC Number: 088994253967; Model Number: DYNJ55462A, UPC Number: 019348928316; Model Number: DYNJ55514A, UPC Number: 088994272740; Model Number: DYNJ55849A, UPC Number: 088994268001; Model Number: DYNJ56624, UPC Number: 088994266543; Model Number: DYNJ56724A, UPC Number: 088994282388; Model Number: DYNJ56724B, UPC Number: 019348946631; Model Number: DYNJ57512, UPC Number: 088994274827; Model Number: DYNJ57835, UPC Number: 088994278233; Model Number: DYNJ57917, UPC Number: 088994279429; Model Number: DYNJ58063, UPC Number: 088994281667; Model Number: DYNJ58609, UPC Number: 088994287126; Model Number: DYNJ59151F, UPC Number: 019348948756; Model Number: DYNJ59662B, UPC Number: 019348943433; Model Number: DYNJ59662D, UPC Number: 019532703087; Model Number: DYNJ59677A, UPC Number: 019348961635; Model Number: DYNJ59681A, UPC Number: 019348946987; Model Number: DYNJ61540C, UPC Number: 019348949512; Model Number: DYNJ63823, UPC Number: 019348976342; Model Number: DYNJ64282, UPC Number: 019348979637; Model Number: DYNJ64471A, UPC Number: 019348941415; Model Number: DYNJ65579, UPC Number: 019348928038; Model Number: DYNJ66154, UPC Number: 019348931778; Model Number: DYNJ66743A, UPC Number: 019348943555; Model Number: DYNJ68749, UPC Number: 019348983668; Model Number: DYNJ69091, UPC Number: 019348988372; Model Number: DYNJ80199A, UPC Number: 019532704086; Model Number: DYNJ80199B, UPC Number: 019532708820; Model Number: DYNJ80868, UPC Number: 019532708250; Model Number: DYNJ83147, UPC Number: 019532723550. y. Model Number: DYNJ66427, UPC Number: 019348935468. z. Model Number: DYNJ66271A, UPC Number: 019348981468; Model Number: DYNJ66271C, UPC Number: 019532709850. aa. Model Number: DYNJ65342A, UPC Number: 019348936966. bb. Model Number: DYNJ38264D, UPC Number: 019348943849; Model Number: DYNJ62038A, UPC Number: 019348932240; Model Number: DYNJ64909, UPC Number: 019348923016. cc. Model Number: DYNJ53616A, UPC Number: 088994268856. dd. Model Number: DYNJ57003, UPC Number: 088994270310; Model Number: DYNJ62829A, UPC Number: 019348930662. ee. Model Number: DYNJ50227C, UPC Number: 088994293861. ff. Model Number: DYNJ61010A, UPC Number: 019348930714. gg. Model Number: DYNJ44421D, UPC Number: 019348948263. hh. Model Number: DYNJ83461, UPC Number: 019532726779. ii. Model Number: CDS984292I, UPC Number: 019348986248. jj. Model Number: DYNJ66076, UPC Number: 019348931923. kk. Model Number: DYNJ66445, UPC Number: 019348935608. ll. Model Number: DYNJ33612G, UPC Number: 019532720495.