BEUDAMED
    FDA Enforcement 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

    Recall: Z-2303-2023 · Reported August 9, 2023

    Enforcement

    Recall Number
    Z-2303-2023
    Event ID
    92399
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 9, 2023
    Initiation Date
    May 15, 2023
    Classification Date
    August 3, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    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

    Reason

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

    Code Info

    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.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

    Quantity

    100,549 kits