Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE PACK, Model Number DYNJ67771; c) EP PACK, Model Number DYNJ68019; d) GWINNETT ENDOVASCULAR WSTE MGT, Model Number DYNJ68198; e) TAVR PACK, Model Number DYNJ68499B; f) VEIN CLINIC, Model Number DYNJ68667; g) VASCULAR PACK, Model Number DYNJ68863; h) VASCULAR PACK, Model Number DYNJ68880; i) TAVR PACK, Model Number DYNJ68933; j) PROCEDURE PACK, Model Number DYNJ68968A; k) PORT PACK, Model Number DYNJ68990A; l) STROKE PACK, Model Number DYNJ69009A; m) ENDOVENOUS BASIC PACK, Model Number DYNJ69108A; n) VEIN ABLATION KIT, Model Number DYNJ69272A; o) UPPER ENDOVASCULAR PK, Model Number DYNJ69302; p) STROKE PACK, Model Number DYNJ69422; q) UNM PREHOSPITAL ECMO PACK, Model Number DYNJ69622; r) UNM ACCESS PACK, Model Number DYNJ69624; s) FLUSHING VASCULAR CENTER, Model Number DYNJ69626; t) AFIB PACK, Model Number DYNJ69682; u) ENDOVASCULAR PACK, Model Number DYNJ69691A; v) FISTULA SAVANNAH PACK, Model Number DYNJ69943A; w) VEIN PACK, Model Number DYNJ80199A; x) VEIN PACK, Model Number DYNJ80199B; y) VASCULAR PACK, Model Number DYNJ80310; z) CAROTID PACK, Model Number DYNJ80346A; aa) ENDOVENOUS ABLATION PACK, Model Number DYNJ80489; bb) STROKE KIT, Model Number DYNJ80506; cc) VEIN PACK, Model Number DYNJ80868; dd) VASCULAR ACCESS PACK, Model Number DYNJ81022; ee) VASCULAR GENERAL PACK, Model Number DYNJ81023; ff) AV FISTULA PACK, Model Number DYNJ81033; gg) TAVR PACK, Model Number DYNJ81095; hh) VASCULAR INSTITUTE OF KS PACK, Model Number DYNJ81200; ii) VASCULAR INSTITUTE OF KS PACK, Model Number DYNJ81200A; jj) LINQ PACK, Model Number DYNJ81320; kk) EP DRAPE, Model Number DYNJ81462A; ll) OR VASCULAR ANGIO PACK, Model Number DYNJ81592A; mm) OR VASCULAR ANGIO PACK, Model Number DYNJ81592B; nn) AV FISTULA PACK, Model Number DYNJ81605; oo) MAJOR VASCULAR PACK, Model Number DYNJ81610; pp) MAJOR VASCULAR PACK, Model Number DYNJ81610A; qq) MAJOR VASCULAR PACK, Model Number DYNJ81610B; rr) PROCEDURE PACK, Model Number DYNJ81618; ss) VASCULAR PACK, Model Number DYNJ81626; tt) VASCULAR PACK, Model Number DYNJ81626A; uu) VASCULAR KIT, Model Number DYNJ81642; vv) VASCULAR KIT, Model Number DYNJ81642A; ww) USGS PACK, Model Number DYNJ81705; xx) EP PACK, Model Number DYNJ81716; yy) EP PACK, Model Number DYNJ81716A; zz) EP PACK, Model Number DYNJ81716B; aaa) VASCULAR PACK, Model Number DYNJ82104; bbb) VASCULAR AND INTERVENTION, Model Number DYNJ82109; ccc) VASCULAR PACK, Model Number DYNJ82144; ddd) SPECIALS MINOR RADIOLOGY PACK, Model Number DYNJ82314; eee) TAVR PACK, Model Number DYNJ82372; fff) FISTULA PACK, Model Number DYNJ82711; ggg) IR ANGIOGRAM LIGHT PK, Model Number DYNJ82858A; hhh) IR ANGIOGRAM PACK, Model Number DYNJ82859A; iii) MARGIN SIMPLE VEIN PACK, Model Number DYNJ82987; jjj) MARGIN FULL VEIN PACK, Model Number DYNJ82988; kkk) MARGIN FULL VEIN PACK, Model Number DYNJ82988A; lll) ARTERIOGRAM PACK 2, Model Number DYNJ83051; mmm) VASCULAR PACK, Model Number DYNJ83146; nnn) VEIN PACK, Model Number DYNJ83147; ooo) ENDOVASCULAR PACK, Model Number DYNJ83161; ppp) CVOR ANGIOGRAPHY PACK, Model Number DYNJ83432; qqq) VIRC STROKE PACK, Model Number DYNJ83461; rrr) RADIO VEIN ABLATION PACK, Model Number DYNJ83490; sss) ENDOVENOUS PACK, Model Number DYNJ83606; ttt) ENDO VASCULAR PACK, Model Number DYNJ83624; uuu) ENDOVASCULAR PACK, Model Number DYNJ83972; vvv) TEMP PERM KIT, Model Number DYNJ84130; www) VASCULAR PACK, Model Number DYNJ84252; xxx) OPEN HEART PART 2, Model Number DYNJ901075O; yyy) OPEN HEART PART 2, Model Number DYNJ901075P; zzz) CAROTID-LF, Model Number DYNJ901745K; aaaa) VASCULAR ANGIO, Model Number DYNJ902259B; bbbb) VASCULAR CUT DOWN, Model Number DYNJ902261G; cccc) VASCULAR, Model Number DYNJ902704P; dddd) ENDOVASCULAR, Model Number DYNJ903451D; eeee) TICKER FIXER2, Model Number DYNJ903919J; ffff) TICK
Hazard / Issue
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Numbers DYNJ67770A, UDI/DI (EA)10195327290979, UDI/DI (CS)40195327290970; b) Model Numbers DYNJ67771, UDI/DI (EA)10193489430721, UDI/DI (CS)40193489430722; c) Model Numbers DYNJ68019, UDI/DI (EA)10193489467840, UDI/DI (CS)40193489467841; d) Model Numbers DYNJ68198, UDI/DI (EA)10193489499179, UDI/DI (CS)40193489499170; e) Model Numbers DYNJ68499B, UDI/DI (EA)10195327034054, UDI/DI (CS)40195327034055; f) Model Numbers DYNJ68667, UDI/DI (EA)10193489837315, UDI/DI (CS)40193489837316; g) Model Numbers DYNJ68863, UDI/DI (EA)10193489845402, UDI/DI (CS)40193489845403; h) Model Numbers DYNJ68880, UDI/DI (EA)10193489847727, UDI/DI (CS)40193489847728; i) Model Numbers DYNJ68933, UDI/DI (EA)10193489860375, UDI/DI (CS)40193489860376; j) Model Numbers DYNJ68968A, UDI/DI (EA)10195327206840, UDI/DI (CS)40195327206841; k) Model Numbers DYNJ68990A, UDI/DI (EA)10193489981360, UDI/DI (CS)40193489981361; l) Model Numbers DYNJ69009A, UDI/DI (EA)10195327075569, UDI/DI (CS)40195327075560; m) Model Numbers DYNJ69108A, UDI/DI (EA)10195327025717, UDI/DI (CS)40195327025718; n) Model Numbers DYNJ69272A, UDI/DI (EA)10195327015800, UDI/DI (CS)40195327015801; o) Model Numbers DYNJ69302, UDI/DI (EA)10193489926279, UDI/DI (CS)40193489926270; p) Model Numbers DYNJ69422, UDI/DI (EA)10193489937541, UDI/DI (CS)40193489937542; q) Model Numbers DYNJ69622, UDI/DI (EA)10193489959581, UDI/DI (CS)40193489959582; r) Model Numbers DYNJ69624, UDI/DI (EA)10193489959567, UDI/DI (CS)40193489959568; s) Model Numbers DYNJ69626, UDI/DI (EA)10193489960693, UDI/DI (CS)40193489960694; t) Model Numbers DYNJ69682, UDI/DI (EA)10193489968927, UDI/DI (CS)40193489968928; u) Model Numbers DYNJ69691A, UDI/DI (EA)10195327070267, UDI/DI (CS)40195327070268; v) Model Numbers DYNJ69943A, UDI/DI (EA)10195327284633, UDI/DI (CS)40195327284634; w) Model Numbers DYNJ80199A, UDI/DI (EA)10195327040864, UDI/DI (CS)40195327040865; x) Model Numbers DYNJ80199B, UDI/DI (EA)10195327088200, UDI/DI (CS)40195327088201; y) Model Numbers DYNJ80310, UDI/DI (EA)10195327023201, UDI/DI (CS)40195327023202; z) Model Numbers DYNJ80346A, UDI/DI (EA)10195327166250, UDI/DI (CS)40195327166251; aa) Model Numbers DYNJ80489, UDI/DI (EA)10195327045845, UDI/DI (CS)40195327045846; bb) Model Numbers DYNJ80506, UDI/DI (EA)10195327049171, UDI/DI (CS)40195327049172; cc) Model Numbers DYNJ80868, UDI/DI (EA)10195327082505, UDI/DI (CS)40195327082506; dd) Model Numbers DYNJ81022, UDI/DI (EA)10195327082789, UDI/DI (CS)40195327082780; ee) Model Numbers DYNJ81023, UDI/DI (EA)10195327082796, UDI/DI (CS)40195327082797; ff) Model Numbers DYNJ81033, UDI/DI (EA)10195327082987, UDI/DI (CS)40195327082988; gg) Model Numbers DYNJ81095, UDI/DI (EA)10195327084127, UDI/DI (CS)40195327084128; hh) Model Numbers DYNJ81200, UDI/DI (EA)10195327091699, UDI/DI (CS)40195327091690; ii) Model Numbers DYNJ81200A, UDI/DI (EA)10195327224714, UDI/DI (CS)40195327224715; jj) Model Numbers DYNJ81320, UDI/DI (EA)10195327110147, UDI/DI (CS)40195327110148; kk) Model Numbers DYNJ81462A, UDI/DI (EA)10195327378615, UDI/DI (CS)40195327378616; ll) Model Numbers DYNJ81592A, UDI/DI (EA)10195327315054, UDI/DI (CS)40195327315055; mm) Model Numbers DYNJ81592B, UDI/DI (EA)10195327398309, UDI/DI (CS)40195327398300; nn) Model Numbers DYNJ81605, UDI/DI (EA)10195327123888, UDI/DI (CS)40195327123889; oo) Model Numbers DYNJ81610, UDI/DI (EA)10195327123949, UDI/DI (CS)40195327123940; pp) Model Numbers DYNJ81610A, UDI/DI (EA)10195327315047, UDI/DI (CS)40195327315048; qq) Model Numbers DYNJ81610B, UDI/DI (EA)10195327398316, UDI/DI (CS)40195327398317; rr) Model Numbers DYNJ81618, UDI/DI (EA)10195327124601, UDI/DI (CS)40195327124602; ss) Model Numbers DYNJ81626, UDI/DI (EA)10195327127060, UDI/DI (CS)40195327127061; tt) Model Numbers DYNJ81626A, UDI/DI (EA)10195327297190, UDI/DI (CS)40195327297191; uu) Model Numbers DYNJ81642, UDI/DI (EA)10195327129668, UDI/DI (CS)40195327129669; vv) Model Numbers DYNJ81642A, UDI/DI (EA)10195327266387, UDI/DI (CS)40195327266388; ww) Model Numbers DYNJ81705, UDI/DI (EA)10195327135577, UDI/DI (CS)40195327135578; xx) Model Numbers DYNJ81716, UDI/DI (EA)10195327138066, UDI/DI (CS)40195327138067; yy) Model Numbers DYNJ81716A, UDI/DI (EA)10195327203856, UDI/DI (CS)40195327203857; zz) Model Numbers DYNJ81716B, UDI/DI (EA)10195327277260, UDI/DI (CS)40195327277261; aaa) Model Numbers DYNJ82104, UDI/DI (EA)10195327171087, UDI/DI (CS)40195327171088; bbb) Model Numbers DYNJ82109, UDI/DI (EA)10195327171247, UDI/DI (CS)40195327171248; ccc) Model Numbers DYNJ82144, UDI/DI (EA)10195327178031, UDI/DI (CS)40195327178032; ddd) Model Numbers DYNJ82314, UDI/DI (EA)10195327184216, UDI/DI (CS)40195327184217; eee) Model Numbers DYNJ82372, UDI/DI (EA)10195327187538, UDI/DI (CS)40195327187539; fff) Model Numbers DYNJ82711, UDI/DI (EA)10195327203627, UDI/DI (CS)40195327203628; ggg) Model Numbers DYNJ82858A, UDI/DI (EA)10195327244897, UDI/DI (CS)40195327244898; hhh) Model Numbers DYNJ82859A, UDI/DI (EA)10195327244903, UDI/DI (CS)40195327244904; iii) Model Numbers DYNJ82987, UDI/DI (EA)10195327222116, UDI/DI (CS)40195327222117; jjj) Model Numbers DYNJ82988, UDI/DI (EA)10195327222208, UDI/DI (CS)40195327222209; kkk) Model Numbers DYNJ82988A, UDI/DI (EA)10195327293314, UDI/DI (CS)40195327293315; lll) Model Numbers DYNJ83051, UDI/DI (EA)10195327245283, UDI/DI (CS)40195327245284; mmm) Model Numbers DYNJ83146, UDI/DI (EA)10195327235680, UDI/DI (CS)40195327235681; nnn) Model Numbers DYNJ83147, UDI/DI (EA)10195327235505, UDI/DI (CS)40195327235506; ooo) Model Numbers DYNJ83161, UDI/DI (EA)10195327237837, UDI/DI (CS)40195327237838; ppp) Model Numbers DYNJ83432, UDI/DI (EA)10195327266530, UDI/DI (CS)40195327266531; qqq) Model Numbers DYNJ83461, UDI/DI (EA)10195327267797, UDI/DI (CS)40195327267798; rrr) Model Numbers DYNJ83490, UDI/DI (EA)10195327271411, UDI/DI (CS)40195327271412; sss) Model Numbers DYNJ83606, UDI/DI (EA)10195327284855, UDI/DI (CS)40195327284856; ttt) Model Numbers DYNJ83624, UDI/DI (EA)10195327285869, UDI/DI (CS)40195327285860; uuu) Model Numbers DYNJ83972, UDI/DI (EA)10195327322694, UDI/DI (CS)40195327322695; vvv) Model Numbers DYNJ84130, UDI/DI (EA)10195327334550, UDI/DI (CS)40195327334551; www) Model Numbers DYNJ84252, UDI/DI (EA)10195327345570, UDI/DI (CS)40195327345571; xxx) Model Numbers DYNJ901075O, UDI/DI (EA)10195327052683, UDI/DI (CS)40195327052684; yyy) Model Numbers DYNJ901075P, UDI/DI (EA)10195327253554, UDI/DI (CS)40195327253555; zzz) Model Numbers DYNJ901745K, UDI/DI (EA)10193489482232, UDI/DI (CS)40193489482233; aaaa) Model Numbers DYNJ902259B, UDI/DI (EA)10193489919714, UDI/DI (CS)40193489919715; bbbb) Model Numbers DYNJ902261G, UDI/DI (EA)10193489919721, UDI/DI (CS)40193489919722; cccc) Model Numbers DYNJ902704P, UDI/DI (EA)10193489863376, UDI/DI (CS)40193489863377; dddd) Model Numbers DYNJ903451D, UDI/DI (EA)10193489667851, UDI/DI (CS)40193489667852; eeee) Model Numbers DYNJ903919J, UDI/DI (EA)10195327045906, UDI/DI (CS)40195327045907; ffff) Model Numbers DYNJ903919K, UDI/DI (EA)10195327218782, UDI/DI (CS)40195327218783; gggg) Model Numbers DYNJ903919L, UDI/DI (EA)10195327267056, UDI/DI (CS)40195327267057; hhhh) Model Numbers DYNJ904171F, UDI/DI (EA)10193489439243, UDI/DI (CS)40193489439244; iiii) Model Numbers DYNJ904401C, UDI/DI (EA)10193489348910, UDI/DI (CS)40193489348911; jjjj) Model Numbers DYNJ904984B, UDI/DI (EA)10193489812930, UDI/DI (CS)40193489812931; kkkk) Model Numbers DYNJ905079F, UDI/DI (EA)10195327209001, UDI/DI (CS)40195327209002; llll) Model Numbers DYNJ905285C, UDI/DI (EA)10193489947250, UDI/DI (CS)40193489947251; mmmm) Model Numbers DYNJ905291B, UDI/DI (EA)10193489950373, UDI/DI (CS)40193489950374; nnnn) Model Numbers DYNJ905291C, UDI/DI (EA)10195327062545, UDI/DI (CS)40195327062546; oooo) Model Numbers DYNJ905311I, UDI/DI (EA)10195327146214, UDI/DI (CS)40195327146215; pppp) Model Numbers DYNJ905516C, UDI/DI (EA)10193489967128, UDI/DI (CS)40193489967129; qqqq) Model Numbers DYNJ905516D, UDI/DI (EA)10195327147839, UDI/DI (CS)40195327147830; rrrr) Model Numbers DYNJ905516F, UDI/DI (EA)10195327247577, UDI/DI (CS)40195327247578; ssss) Model Numbers DYNJ905726C, UDI/DI (EA)10193489943375, UDI/DI (CS)40193489943376; tttt) Model Numbers DYNJ905726D, UDI/DI (EA)10195327161514, UDI/DI (CS)40195327161515; uuuu) Model Numbers DYNJ905744C, UDI/DI (EA)10195327162313, UDI/DI (CS)40195327162314; vvvv) Model Numbers DYNJ905859B, UDI/DI (EA)10193489417869, UDI/DI (CS)40193489417860; wwww) Model Numbers DYNJ905884A, UDI/DI (EA)10193489795448, UDI/DI (CS)40193489795449; xxxx) Model Numbers DYNJ906086B, UDI/DI (EA)10195327046354, UDI/DI (CS)40195327046355; yyyy) Model Numbers DYNJ906098A, UDI/DI (EA)10193489209457, UDI/DI (CS)40193489209458; zzzz) Model Numbers DYNJ906102F, UDI/DI (EA)10195327028268, UDI/DI (CS)40195327028269;