Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEIN SPECIALISTS PACK, Model Number DYNJ53616A; c) SUMMIT SKIN AND VEIN PACK, Model Number DYNJ54014B; d) VEIN PACK, Model Number DYNJ54153B; e) RFD-ENDOVASCULAR OR PACK, Model Number DYNJ54265A; f) PEDI EP PACK, Model Number DYNJ54750G; g) EL PASO VERICOSE VEIN PACK, Model Number DYNJ54803C; h) LEE VEIN PACK, Model Number DYNJ54906B; i) HEART FAILURE PK, Model Number DYNJ55528A; j) HEART FAILURE PK, Model Number DYNJ55528B; k) HEART FAILURE PK, Model Number DYNJ55528C; l) ROCKWAY VASCULAR PACK-LF, Model Number DYNJ55757C; m) OPEN HEART ANGIO PACK, Model Number DYNJ55836B; n) DR NACKMAN VEIN PACK, Model Number DYNJ56235; o) KT TAVR PACK, Model Number DYNJ56283D; p) KT TAVR PACK, Model Number DYNJ56283F; q) VEIN PACK, Model Number DYNJ56724B; r) VASCULAR PACK, Model Number DYNJ56791A; s) VASCULAR PACK, Model Number DYNJ56791B; t) ECMO PACK, Model Number DYNJ56904; u) VEIN KIT, Model Number DYNJ57047; v) EH TAVR PACK, Model Number DYNJ57449F; w) EH TAVR PACK, Model Number DYNJ57449G; x) VASCULAR PACK, Model Number DYNJ57490A; y) VEIN PACK, Model Number DYNJ57512; z) DEVICE PACK, Model Number DYNJ57595A; aa) CAROTID PACK-LF, Model Number DYNJ57646B; bb) CAROTID PACK-LF, Model Number DYNJ57646C; cc) CATH LAB PACK, Model Number DYNJ57735F; dd) VEIN PACK, Model Number DYNJ57835; ee) VEIN PACK, Model Number DYNJ57917; ff) ENS. THROMBOLYSE/EMBOLISAT-LF, Model Number DYNJ58179C; gg) HEART VALVE PACK, Model Number DYNJ58365J; hh) VEIN PACK, Model Number DYNJ58609; ii) VASCULAR PACK, Model Number DYNJ58681A; jj) VASCULAR PACK, Model Number DYNJ58681B; kk) VASCULAR PACK, Model Number DYNJ58710; ll) DR HARRISON VEIN PACK II, Model Number DYNJ59028A; mm) VEIN PACK, Model Number DYNJ59151F; nn) EP LAB, Model Number DYNJ59392D; oo) EP LAB, Model Number DYNJ59392F; pp) VEIN PACK, Model Number DYNJ59662D; qq) VEIN PACK, Model Number DYNJ59681A; rr) VASCULAR PACK CHRG, Model Number DYNJ59778B; ss) VASCULAR ACCESS KIT, Model Number DYNJ59796C; tt) CATH PACK, Model Number DYNJ59830A; uu) VENOUS ACCESS ACCESSORY PACK, Model Number DYNJ61010A; vv) DR SIRAGUSA VEIN PACK, Model Number DYNJ61247; ww) MAIN OR CATH LAB, Model Number DYNJ61373; xx) VASCULAR PACK, Model Number DYNJ61528; yy) VASCULAR PACK, Model Number DYNJ61528A; zz) VEIN PACK, Model Number DYNJ61540C; aaa) NEURO VASCULAR PACK, Model Number DYNJ61584A; bbb) ABLATION PACK, Model Number DYNJ61957A; ccc) HEART GROIN PACK, Model Number DYNJ61981C; ddd) PERMA CATH PACK, Model Number DYNJ62007B; eee) PURPLE PACK, Model Number DYNJ62197A; fff) PURPLE PACK, Model Number DYNJ62197B; ggg) CLOVIS CATH LAB PACK, Model Number DYNJ62379A; hhh) VASCULAR PACK, Model Number DYNJ62399A; iii) NORTH TEXAS VASCULAR, Model Number DYNJ62735; jjj) VEIN TRAY, Model Number DYNJ62829A; kkk) HEART VEIN NYC LASER ABLATION, Model Number DYNJ62850A; lll) HEART VEIN NYC -ARTERIAL PACK, Model Number DYNJ62851B; mmm) TAVR PACK, Model Number DYNJ62915B; nnn) PACER SET UP PACK, Model Number DYNJ63069A; ooo) OPEN HEART TAVR PACK, Model Number DYNJ63099D; ppp) OPEN HEART TAVR PACK, Model Number DYNJ63099F; qqq) ELECTROPHYSIOLOGY PACK, Model Number DYNJ63209; rrr) TAVR PACK, Model Number DYNJ63340A; sss) VEIN PACK, Model Number DYNJ63823; ttt) NIR PACK, Model Number DYNJ63892A; uuu) VEIN ABLATION TRAY W/CHLOR, Model Number DYNJ64396; vvv) TORRES-VEIN PACK, Model Number DYNJ64449; www) VEIN PACK, Model Number DYNJ64471A; xxx) CVOR ENDOVASCULAR PACK, Model Number DYNJ64506A; yyy) HEART FAILURE PACK, Model Number DYNJ64877B; zzz) CT ABLATION PACK, Model Number DYNJ64928; aaaa) VEIN PROCEDURE, Model Number DYNJ65342A; bbbb) SMALL TRAY VASCULAR PACK, Model Number DYNJ65418; cccc) VEIN OHH, Model Number DYNJ65560A; dddd) PORT PICC TUNNEL PACK, Model Number DYNJ65775A; eeee) VARITHENA PACK, Model Number DYNJ65
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 DYNJ53433K, UDI/DI (EA)10195327339487, UDI/DI (CS)40195327339488; b) Model Numbers DYNJ53616A, UDI/DI (EA)10889942688562, UDI/DI (CS)40889942688563; c) Model Numbers DYNJ54014B, UDI/DI (EA)10889942760329, UDI/DI (CS)40889942760320; d) Model Numbers DYNJ54153B, UDI/DI (EA)10889942714421, UDI/DI (CS)40889942714422; e) Model Numbers DYNJ54265A, UDI/DI (EA)10195327152338, UDI/DI (CS)40195327152339; f) Model Numbers DYNJ54750G, UDI/DI (EA)10195327021351, UDI/DI (CS)40195327021352; g) Model Numbers DYNJ54803C, UDI/DI (EA)10193489202618, UDI/DI (CS)40193489202619; h) Model Numbers DYNJ54906B, UDI/DI (EA)10193489289633, UDI/DI (CS)40193489289634; i) Model Numbers DYNJ55528A, UDI/DI (EA)10889942976638, UDI/DI (CS)40889942976639; j) Model Numbers DYNJ55528B, UDI/DI (EA)10195327046491, UDI/DI (CS)40195327046492; k) Model Numbers DYNJ55528C, UDI/DI (EA)10195327248208, UDI/DI (CS)40195327248209; l) Model Numbers DYNJ55757C, UDI/DI (EA)10195327116538, UDI/DI (CS)40195327116539; m) Model Numbers DYNJ55836B, UDI/DI (EA)10193489951172, UDI/DI (CS)40193489951173; n) Model Numbers DYNJ56235, UDI/DI (EA)10889942621552, UDI/DI (CS)40889942621553; o) Model Numbers DYNJ56283D, UDI/DI (EA)10195327093877, UDI/DI (CS)40195327093878; p) Model Numbers DYNJ56283F, UDI/DI (EA)10195327211851, UDI/DI (CS)40195327211852; q) Model Numbers DYNJ56724B, UDI/DI (EA)10193489466317, UDI/DI (CS)40193489466318; r) Model Numbers DYNJ56791A, UDI/DI (EA)10193489594119, UDI/DI (CS)40193489594110; s) Model Numbers DYNJ56791B, UDI/DI (EA)10195327045678, UDI/DI (CS)40195327045679; t) Model Numbers DYNJ56904, UDI/DI (EA)10889942693450, UDI/DI (CS)40889942693451; u) Model Numbers DYNJ57047, UDI/DI (EA)10889942710485, UDI/DI (CS)40889942710486; v) Model Numbers DYNJ57449F, UDI/DI (EA)10193489939200, UDI/DI (CS)40193489939201; w) Model Numbers DYNJ57449G, UDI/DI (EA)10195327064884, UDI/DI (CS)40195327064885; x) Model Numbers DYNJ57490A, UDI/DI (EA)10193489641998, UDI/DI (CS)40193489641999; y) Model Numbers DYNJ57512, UDI/DI (EA)10889942748273, UDI/DI (CS)40889942748274; z) Model Numbers DYNJ57595A, UDI/DI (EA)10193489622157, UDI/DI (CS)40193489622158; aa) Model Numbers DYNJ57646B, UDI/DI (EA)10193489828504, UDI/DI (CS)40193489828505; bb) Model Numbers DYNJ57646C, UDI/DI (EA)10195327287139, UDI/DI (CS)40195327287130; cc) Model Numbers DYNJ57735F, UDI/DI (EA)10193489629705, UDI/DI (CS)40193489629706; dd) Model Numbers DYNJ57835, UDI/DI (EA)10889942782338, UDI/DI (CS)40889942782339; ee) Model Numbers DYNJ57917, UDI/DI (EA)10889942794294, UDI/DI (CS)40889942794295; ff) Model Numbers DYNJ58179C, UDI/DI (EA)10195327209926, UDI/DI (CS)40195327209927; gg) Model Numbers DYNJ58365J, UDI/DI (EA)10195327019099, UDI/DI (CS)40195327019090; hh) Model Numbers DYNJ58609, UDI/DI (EA)10889942871261, UDI/DI (CS)40889942871262; ii) Model Numbers DYNJ58681A, UDI/DI (EA)10888277798489, UDI/DI (CS)40888277798480; jj) Model Numbers DYNJ58681B, UDI/DI (EA)10195327293376, UDI/DI (CS)40195327293377; kk) Model Numbers DYNJ58710, UDI/DI (EA)10889942880850, UDI/DI (CS)40889942880851; ll) Model Numbers DYNJ59028A, UDI/DI (EA)10193489736595, UDI/DI (CS)40193489736596; mm) Model Numbers DYNJ59151F, UDI/DI (EA)10193489487565, UDI/DI (CS)40193489487566; nn) Model Numbers DYNJ59392D, UDI/DI (EA)10195327053574, UDI/DI (CS)40195327053575; oo) Model Numbers DYNJ59392F, UDI/DI (EA)10195327135980, UDI/DI (CS)40195327135981; pp) Model Numbers DYNJ59662D, UDI/DI (EA)10195327030872, UDI/DI (CS)40195327030873; qq) Model Numbers DYNJ59681A, UDI/DI (EA)10193489469875, UDI/DI (CS)40193489469876; rr) Model Numbers DYNJ59778B, UDI/DI (EA)10193489695922, UDI/DI (CS)40193489695923; ss) Model Numbers DYNJ59796C, UDI/DI (EA)10193489904215, UDI/DI (CS)40193489904216; tt) Model Numbers DYNJ59830A, UDI/DI (EA)10193489570236, UDI/DI (CS)40193489570237; uu) Model Numbers DYNJ61010A, UDI/DI (EA)10193489307146, UDI/DI (CS)40193489307147; vv) Model Numbers DYNJ61247, UDI/DI (EA)10193489551709, UDI/DI (CS)40193489551700; ww) Model Numbers DYNJ61373, UDI/DI (EA)10193489576696, UDI/DI (CS)40193489576697; xx) Model Numbers DYNJ61528, UDI/DI (EA)10193489578980, UDI/DI (CS)40193489578981; yy) Model Numbers DYNJ61528A, UDI/DI (EA)10195327336714, UDI/DI (CS)40195327336715; zz) Model Numbers DYNJ61540C, UDI/DI (EA)10193489495126, UDI/DI (CS)40193489495127; aaa) Model Numbers DYNJ61584A, UDI/DI (EA)10193489812817, UDI/DI (CS)40193489812818; bbb) Model Numbers DYNJ61957A, UDI/DI (EA)10193489699074, UDI/DI (CS)40193489699075; ccc) Model Numbers DYNJ61981C, UDI/DI (EA)10195327106027, UDI/DI (CS)40195327106028; ddd) Model Numbers DYNJ62007B, UDI/DI (EA)10195327161965, UDI/DI (CS)40195327161966; eee) Model Numbers DYNJ62197A, UDI/DI (EA)10193489994094, UDI/DI (CS)40193489994095; fff) Model Numbers DYNJ62197B, UDI/DI (EA)10195327167240, UDI/DI (CS)40195327167241; ggg) Model Numbers DYNJ62379A, UDI/DI (EA)10195327196639, UDI/DI (CS)40195327196630; hhh) Model Numbers DYNJ62399A, UDI/DI (EA)10193489250268, UDI/DI (CS)40193489250269; iii) Model Numbers DYNJ62735, UDI/DI (EA)10193489685282, UDI/DI (CS)40193489685283; jjj) Model Numbers DYNJ62829A, UDI/DI (EA)10193489306620, UDI/DI (CS)40193489306621; kkk) Model Numbers DYNJ62850A, UDI/DI (EA)10193489784237, UDI/DI (CS)40193489784238; lll) Model Numbers DYNJ62851B, UDI/DI (EA)10193489271218, UDI/DI (CS)40193489271219; mmm) Model Numbers DYNJ62915B, UDI/DI (EA)10193489365351, UDI/DI (CS)40193489365352; nnn) Model Numbers DYNJ63069A, UDI/DI (EA)10193489423617, UDI/DI (CS)40193489423618; ooo) Model Numbers DYNJ63099D, UDI/DI (EA)10193489932690, UDI/DI (CS)40193489932691; ppp) Model Numbers DYNJ63099F, UDI/DI (EA)10195327150037, UDI/DI (CS)40195327150038; qqq) Model Numbers DYNJ63209, UDI/DI (EA)10193489727883, UDI/DI (CS)40193489727884; rrr) Model Numbers DYNJ63340A, UDI/DI (EA)10195327273583, UDI/DI (CS)40195327273584; sss) Model Numbers DYNJ63823, UDI/DI (EA)10193489763423, UDI/DI (CS)40193489763424; ttt) Model Numbers DYNJ63892A, UDI/DI (EA)10195327176518, UDI/DI (CS)40195327176519; uuu) Model Numbers DYNJ64396, UDI/DI (EA)10193489810509, UDI/DI (CS)40193489810500; vvv) Model Numbers DYNJ64449, UDI/DI (EA)10193489201574, UDI/DI (CS)40193489201575; www) Model Numbers DYNJ64471A, UDI/DI (EA)10193489414158, UDI/DI (CS)40193489414159; xxx) Model Numbers DYNJ64506A, UDI/DI (EA)10193489971064, UDI/DI (CS)40193489971065; yyy) Model Numbers DYNJ64877B, UDI/DI (EA)10193489415896, UDI/DI (CS)40193489415897; zzz) Model Numbers DYNJ64928, UDI/DI (EA)10193489231502, UDI/DI (CS)40193489231503; aaaa) Model Numbers DYNJ65342A, UDI/DI (EA)10193489369663, UDI/DI (CS)40193489369664; bbbb) Model Numbers DYNJ65418, UDI/DI (EA)10193489273717, UDI/DI (CS)40193489273718; cccc) Model Numbers DYNJ65560A, UDI/DI (EA)10193489397185, UDI/DI (CS)40193489397186; dddd) Model Numbers DYNJ65775A, UDI/DI (EA)10195327140229, UDI/DI (CS)40195327140220; eeee) Model Numbers DYNJ65842, UDI/DI (EA)10193489296310, UDI/DI (CS)40193489296311; ffff) Model Numbers DYNJ66076, UDI/DI (EA)10193489319231, UDI/DI (CS)40193489319232; gggg) Model Numbers DYNJ66152A, UDI/DI (EA)10193489820218, UDI/DI (CS)40193489820219; hhhh) Model Numbers DYNJ66152B, UDI/DI (EA)10195327090425, UDI/DI (CS)40195327090426; iiii) Model Numbers DYNJ66271C, UDI/DI (EA)10195327098506, UDI/DI (CS)40195327098507; jjjj) Model Numbers DYNJ66356C, UDI/DI (EA)10193489991055, UDI/DI (CS)40193489991056; kkkk) Model Numbers DYNJ66356D, UDI/DI (EA)10195327060299, UDI/DI (CS)40195327060290; llll) Model Numbers DYNJ66356G, UDI/DI (EA)10195327357306, UDI/DI (CS)40195327357307; mmmm) Model Numbers DYNJ66427, UDI/DI (EA)10193489354683, UDI/DI (CS)40193489354684; nnnn) Model Numbers DYNJ66445, UDI/DI (EA)10193489356083, UDI/DI (CS)40193489356084; oooo) Model Numbers DYNJ66743A, UDI/DI (EA)10193489435559, UDI/DI (CS)40193489435550; pppp) Model Numbers DYNJ66769, UDI/DI (EA)10193489380521, UDI/DI (CS)40193489380522; qqqq) Model Numbers DYNJ66916A, UDI/DI (EA)10193489993226, UDI/DI (CS)40193489993227; rrrr) Model Numbers DYNJ66926B, UDI/DI (EA)10195327340261, UDI/DI (CS)40195327340262; ssss) Model Numbers DYNJ67487B, UDI/DI (EA)10195327166144, UDI/DI (CS)40195327166145; tttt) Model Numbers DYNJ67487C, UDI/DI (EA)10195327260743, UDI/DI (CS)40195327260744; uuuu) Model Numbers DYNJ67517A, UDI/DI (EA)10193489462197, UDI/DI (CS)40193489462198; vvvv) Model Numbers DYNJ67725, UDI/DI (EA)10193489425840, UDI/DI (CS)40193489425841; wwww) Model Numbers DYNJ67750A, UDI/DI (EA)10193489832242, UDI/DI (CS)40193489832243; xxxx) Model Numbers DYNJ67750B, UDI/DI (EA)10193489912043, UDI/DI (CS)40193489912044; yyyy) Model Numbers DYNJ67750C, UDI/DI (EA)10195327341367, UDI/DI (CS)40195327341368; zzzz) Model Numbers DYNJ67770, UDI/DI (EA)10193489430714, UDI/DI (CS)40193489430715;