Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model Number DYNJ56140B; d) VENOUS PACK, Model Number DYNJ56260B; e) WMC ULTRASOUND PACK, Model Number DYNJ56392; f) WMC ULTRASOUND PACK, Model Number DYNJ56392A; g) WMC ULTRASOUND PACK, Model Number DYNJ56392B; h) ULTRASOUND KIT-LF, Model Number DYNJ56507B; i) EVLT PACK, Model Number DYNJ56548B; j) RFA PACK, Model Number DYNJ57149; k) SPECIALS TRACE PACK, Model Number DYNJ57303B; l) CLOSURE PACK, Model Number DYNJ57514; m) EP PACK, Model Number DYNJ57594A; n) VEIN TRAY, Model Number DYNJ57736A; o) ENSEMBLE PICC LINE-LF, Model Number DYNJ57793; p) PICC LINE PACK-LF, Model Number DYNJ58160; q) ENDOVENOUS PACK, Model Number DYNJ58228; r) BIB AV FISTULA PACK, Model Number DYNJ58304; s) TRIPLE P KIT, Model Number DYNJ58424; t) LINQ TRAY, Model Number DYNJ58643A; u) TUBE CHANGE/SINOGRAM PACK, Model Number DYNJ59062; v) PICC PROCEDURE PACK, Model Number DYNJ59067; w) ENDOVASCULAR PACK, Model Number DYNJ59085; x) VEIN CLOSURE PACK, Model Number DYNJ59094; y) CLOSURE PROCEDURE, Model Number DYNJ59206; z) VNUS PACK, Model Number DYNJ59246; aa) DESERT CARDIOVASCULAR PACK, Model Number DYNJ59377; bb) EP LAB, Model Number DYNJ59392C; cc) VEIN PACK-LF, Model Number DYNJ59631; dd) PROCEDURE PACK, Model Number DYNJ59795A; ee) PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126A; ff) KF PACK, Model Number DYNJ60127A; gg) VENASEAL PACK, Model Number DYNJ60128A; hh) I.R. PACK, Model Number DYNJ60343A; ii) CLOSURE PACK, Model Number DYNJ60804; jj) CLOVIS MINOR IR PROCEDURE-LF, Model Number DYNJ61067; kk) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099A; ll) ECMO PACK, Model Number DYNJ61243; mm) VEIN PACK, Model Number DYNJ61264; nn) UNIVERSAL PACK, Model Number DYNJ61433; oo) OCEANA VEIN PROCEDURE PACK, Model Number DYNJ61517; pp) ENSEMBLE CHIMIO EMBOLISATION, Model Number DYNJ62295; qq) ENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295A; rr) ENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295B; ss) SCLEROTHERAPY KIT, Model Number DYNJ62434A; tt) ABLATION PACK, Model Number DYNJ62540; uu) PROCEDURE PACK, Model Number DYNJ62588; vv) VEIN ABLATION, Model Number DYNJ63268B; ww) TF TAVR PACK, Model Number DYNJ63340; xx) AFCH DRUG INFUSION PUMP PA, Model Number DYNJ63354C; yy) ALL PURPOSE TRAY FOAKS, Model Number DYNJ63576A; zz) NIR PACK, Model Number DYNJ63892; aaa) ABLATION PACK, Model Number DYNJ64068; bbb) LASER KIT, Model Number DYNJ64075A; ccc) EVLT, Model Number DYNJ64336; ddd) PROCEDURE PACK, Model Number DYNJ64372A; eee) PREMIER PROCEDURE PACK, Model Number DYNJ64393; fff) MINOR SET UP PACK, Model Number DYNJ64439; ggg) VIP PACK, Model Number DYNJ64666A; hhh) CT ABLATION PACK, Model Number DYNJ64928A; iii) ULTRASOUND KIT, Model Number DYNJ64930; jjj) VEIN CLOSURE PACK, Model Number DYNJ65189C; kkk) PACK,LTD BODY SSP, Model Number DYNJ65488B; lll) EVLT PACK, Model Number DYNJ65995; mmm) EVLT PACK, Model Number DYNJ65995A; nnn) EVLT PACK, Model Number DYNJ66005; ooo) JVL-PACK TUNNELED, Model Number DYNJ66065; ppp) EVLA PACK, Model Number DYNJ66258; qqq) EVLA PACK, Model Number DYNJ66258A; rrr) ANGIOGRAM SET UP PACK, Model Number DYNJ66260; sss) IR PACKER, Model Number DYNJ66620A; ttt) CLOSURE PROCEDURE PACK, Model Number DYNJ66741; uuu) PHYSIATRY PACK, Model Number DYNJ67414; vvv) FEM POP PACK, Model Number DYNJ67487A; www) SPECIALS PACK, Model Number DYNJ67504A; xxx) SPECIALS PACK, Model Number DYNJ67504B; yyy) RFA PACK, Model Number DYNJ67899; zzz) RR-BRACHY PACK, Model Number DYNJ68027; aaaa) COPS PROCEDURE PACK-LF, Model Number DYNJ68923A; bbbb) PROCEDURE PACK, Model Number DYNJ68968; cccc) PORT PACK, Model Number DYNJ68990; dddd) ACCESS PACK, Model Number DYNJ69017; eeee) KF PACK 2.0, Model Number DYNJ69619; ffff) NLK BASIC PACK, Model Number DYNJ69716A; gg
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 Number DYNJ55841B, UDI/DI (EA) 10888277757684, UDI/DI (CS) 40888277757685; b) Model Number DYNJ55954B, UDI/DI (EA) 10193489214239, UDI/DI (CS) 40193489214230; c) Model Number DYNJ56140B, UDI/DI (EA) 10193489547672, UDI/DI (CS) 40193489547673; d) Model Number DYNJ56260B, UDI/DI (EA) 10193489569827, UDI/DI (CS) 40193489569828; e) Model Number DYNJ56392, UDI/DI (EA) 10889942640676, UDI/DI (CS) 40889942640677; f) Model Number DYNJ56392A, UDI/DI (EA) 10195327261405, UDI/DI (CS) 40195327261406; g) Model Number DYNJ56392B, UDI/DI (EA) 10195327323677, UDI/DI (CS) 40195327323678; h) Model Number DYNJ56507B, UDI/DI (EA) 10193489443479, UDI/DI (CS) 40193489443470; i) Model Number DYNJ56548B, UDI/DI (EA) 10193489813180, UDI/DI (CS) 40193489813181; j) Model Number DYNJ57149, UDI/DI (EA) 10889942721603, UDI/DI (CS) 40889942721604; k) Model Number DYNJ57303B, UDI/DI (EA) 10193489360646, UDI/DI (CS) 40193489360647; l) Model Number DYNJ57514, UDI/DI (EA) 10889942747849, UDI/DI (CS) 40889942747840; m) Model Number DYNJ57594A, UDI/DI (EA) 10889942963218, UDI/DI (CS) 40889942963219; n) Model Number DYNJ57736A, UDI/DI (EA) 10888277779709, UDI/DI (CS) 40888277779700; o) Model Number DYNJ57793, UDI/DI (EA) 10889942819164, UDI/DI (CS) 40889942819165; p) Model Number DYNJ58160, UDI/DI (EA) 10889942828647, UDI/DI (CS) 40889942828648; q) Model Number DYNJ58228, UDI/DI (EA) 10889942835492, UDI/DI (CS) 40889942835493; r) Model Number DYNJ58304, UDI/DI (EA) 10889942843732, UDI/DI (CS) 40889942843733; s) Model Number DYNJ58424, UDI/DI (EA) 10889942851836, UDI/DI (CS) 40889942851837; t) Model Number DYNJ58643A, UDI/DI (EA) 10193489809213, UDI/DI (CS) 40193489809214; u) Model Number DYNJ59062, UDI/DI (EA) 10889942941650, UDI/DI (CS) 40889942941651; v) Model Number DYNJ59067, UDI/DI (EA) 10889942930043, UDI/DI (CS) 40889942930044; w) Model Number DYNJ59085, UDI/DI (EA) 10889942932016, UDI/DI (CS) 40889942932017; x) Model Number DYNJ59094, UDI/DI (EA) 10889942933501, UDI/DI (CS) 40889942933502; y) Model Number DYNJ59206, UDI/DI (EA) 10888277765573, UDI/DI (CS) 40888277765574; z) Model Number DYNJ59246, UDI/DI (EA) 10888277767294, UDI/DI (CS) 40888277767295; aa) Model Number DYNJ59377, UDI/DI (EA) 10888277736290, UDI/DI (CS) 40888277736291; bb) Model Number DYNJ59392C, UDI/DI (EA) 10193489282245, UDI/DI (CS) 40193489282246; cc) Model Number DYNJ59631, UDI/DI (EA) 10888277764026, UDI/DI (CS) 40888277764027; dd) Model Number DYNJ59795A, UDI/DI (EA) 10193489566987, UDI/DI (CS) 40193489566988; ee) Model Number DYNJ60126A, UDI/DI (EA) 10193489247084, UDI/DI (CS) 40193489247085; ff) Model Number DYNJ60127A, UDI/DI (EA) 10193489729047, UDI/DI (CS) 40193489729048; gg) Model Number DYNJ60128A, UDI/DI (EA) 10193489544510, UDI/DI (CS) 40193489544511; hh) Model Number DYNJ60343A, UDI/DI (EA) 10193489573831, UDI/DI (CS) 40193489573832; ii) Model Number DYNJ60804, UDI/DI (EA) 10193489532784, UDI/DI (CS) 40193489532785; jj) Model Number DYNJ61067, UDI/DI (EA) 10193489542226, UDI/DI (CS) 40193489542227; kk) Model Number DYNJ61099A, UDI/DI (EA) 10193489463965, UDI/DI (CS) 40193489463966; ll) Model Number DYNJ61243, UDI/DI (EA) 10193489550917, UDI/DI (CS) 40193489550918; mm) Model Number DYNJ61264, UDI/DI (EA) 10193489554472, UDI/DI (CS) 40193489554473; nn) Model Number DYNJ61433, UDI/DI (EA) 10193489565171, UDI/DI (CS) 40193489565172; oo) Model Number DYNJ61517, UDI/DI (EA) 10193489577570, UDI/DI (CS) 40193489577571; pp) Model Number DYNJ62295, UDI/DI (EA) 10193489641165, UDI/DI (CS) 40193489641166; qq) Model Number DYNJ62295A, UDI/DI (EA) 10193489845952, UDI/DI (CS) 40193489845953; rr) Model Number DYNJ62295B, UDI/DI (EA) 10195327209933, UDI/DI (CS) 40195327209934; ss) Model Number DYNJ62434A, UDI/DI (EA) 10193489366273, UDI/DI (CS) 40193489366274; tt) Model Number DYNJ62540, UDI/DI (EA) 10193489666472, UDI/DI (CS) 40193489666473; uu) Model Number DYNJ62588, UDI/DI (EA) 10193489669831, UDI/DI (CS) 40193489669832; vv) Model Number DYNJ63268B, UDI/DI (EA) 10193489305111, UDI/DI (CS) 40193489305112; ww) Model Number DYNJ63340, UDI/DI (EA) 10193489741162, UDI/DI (CS) 40193489741163; xx) Model Number DYNJ63354C, UDI/DI (EA) 10195327273255, UDI/DI (CS) 40195327273256; yy) Model Number DYNJ63576A, UDI/DI (EA) 10193489429251, UDI/DI (CS) 40193489429252; zz) Model Number DYNJ63892, UDI/DI (EA) 10193489771435, UDI/DI (CS) 40193489771436; aaa) Model Number DYNJ64068, UDI/DI (EA) 10193489783131, UDI/DI (CS) 40193489783132; bbb) Model Number DYNJ64075A, UDI/DI (EA) 10193489231328, UDI/DI (CS) 40193489231329; ccc) Model Number DYNJ64336, UDI/DI (EA) 10193489801873, UDI/DI (CS) 40193489801874; ddd) Model Number DYNJ64372A, UDI/DI (EA) 10193489884685, UDI/DI (CS) 40193489884686; eee) Model Number DYNJ64393, UDI/DI (EA) 10193489809633, UDI/DI (CS) 40193489809634; fff) Model Number DYNJ64439, UDI/DI (EA) 10193489200485, UDI/DI (CS) 40193489200486; ggg) Model Number DYNJ64666A, UDI/DI (EA) 10193489317268, UDI/DI (CS) 40193489317269; hhh) Model Number DYNJ64928A, UDI/DI (EA) 10195327329815, UDI/DI (CS) 40195327329816; iii) Model Number DYNJ64930, UDI/DI (EA) 10193489231687, UDI/DI (CS) 40193489231688; jjj) Model Number DYNJ65189C, UDI/DI (EA) 10195327072001, UDI/DI (CS) 40195327072002; kkk) Model Number DYNJ65488B, UDI/DI (EA) 10193489443646, UDI/DI (CS) 40193489443647; lll) Model Number DYNJ65995, UDI/DI (EA) 10193489311549, UDI/DI (CS) 40193489311540; mmm) Model Number DYNJ65995A, UDI/DI (EA) 10195327068127, UDI/DI (CS) 40195327068128; nnn) Model Number DYNJ66005, UDI/DI (EA) 10193489312546, UDI/DI (CS) 40193489312547; ooo) Model Number DYNJ66065, UDI/DI (EA) 10193489319187, UDI/DI (CS) 40193489319188; ppp) Model Number DYNJ66258, UDI/DI (EA) 10193489325478, UDI/DI (CS) 40193489325479; qqq) Model Number DYNJ66258A, UDI/DI (EA) 10195327194239, UDI/DI (CS) 40195327194230; rrr) Model Number DYNJ66260, UDI/DI (EA) 10193489325461, UDI/DI (CS) 40193489325462; sss) Model Number DYNJ66620A, UDI/DI (EA) 10193489914245, UDI/DI (CS) 40193489914246; ttt) Model Number DYNJ66741, UDI/DI (EA) 10193489374940, UDI/DI (CS) 40193489374941; uuu) Model Number DYNJ67414, UDI/DI (EA) 10193489964646, UDI/DI (CS) 40193489964647; vvv) Model Number DYNJ67487A, UDI/DI (EA) 10193489888997, UDI/DI (CS) 40193489888998; www) Model Number DYNJ67504A, UDI/DI (EA) 10195327009618, UDI/DI (CS) 40195327009619; xxx) Model Number DYNJ67504B, UDI/DI (EA) 10195327331023, UDI/DI (CS) 40195327331024; yyy) Model Number DYNJ67899, UDI/DI (EA) 10193489454499, UDI/DI (CS) 40193489454490; zzz) Model Number DYNJ68027, UDI/DI (EA) 10193489469158, UDI/DI (CS) 40193489469159; aaaa) Model Number DYNJ68923A, UDI/DI (EA) 10195327070793, UDI/DI (CS) 40195327070794; bbbb) Model Number DYNJ68968, UDI/DI (EA) 10193489870398, UDI/DI (CS) 40193489870399; cccc) Model Number DYNJ68990, UDI/DI (EA) 10193489872613, UDI/DI (CS) 40193489872614; dddd) Model Number DYNJ69017, UDI/DI (EA) 10193489878158, UDI/DI (CS) 40193489878159; eeee) Model Number DYNJ69619, UDI/DI (EA) 10193489959444, UDI/DI (CS) 40193489959445; ffff) Model Number DYNJ69716A, UDI/DI (EA) 10195327250577, UDI/DI (CS) 40195327250578; gggg) Model Number DYNJ69820, UDI/DI (EA) 10193489981438, UDI/DI (CS) 40193489981439; hhhh) Model Number DYNJ80299, UDI/DI (EA) 10195327021931, UDI/DI (CS) 40195327021932; iiii) Model Number DYNJ81343, UDI/DI (EA) 10195327113063, UDI/DI (CS) 40195327113064; jjjj) Model Number DYNJ83152, UDI/DI (EA) 10195327237080, UDI/DI (CS) 40195327237081; kkkk) Model Number DYNJ83524, UDI/DI (EA) 10195327273491, UDI/DI (CS) 40195327273492; llll) Model Number DYNJ83931, UDI/DI (EA) 10195327315351, UDI/DI (CS) 40195327315352; mmmm) Model Number DYNJ83976, UDI/DI (EA) 10195327323196, UDI/DI (CS) 40195327323197; nnnn) Model Number DYNJ84172, UDI/DI (EA) 10195327338909, UDI/DI (CS) 40195327338900; oooo) Model Number DYNJ901348D, UDI/DI (EA) 10193489594683, UDI/DI (CS) 40193489594684; pppp) Model Number DYNJ901392D, UDI/DI (EA) 10193489539516, UDI/DI (CS) 40193489539517; qqqq) Model Number DYNJ902168D, UDI/DI (EA) 10193489866155, UDI/DI (CS) 40193489866156; rrrr) Model Number DYNJ902281, UDI/DI (EA) 10888277981416, UDI/DI (CS) 40888277981417; ssss) Model Number DYNJ905002A, UDI/DI (EA) 10889942911653, UDI/DI (CS) 40889942911654; tttt) Model Number DYNJ905335, UDI/DI (EA) 10889942875894, UDI/DI (CS) 40889942875895; uuuu) Model Number DYNJ905651B, UDI/DI (EA) 10193489925067, UDI/DI (CS) 40193489925068; vvvv) Model Number DYNJ905936B, UDI/DI (EA) 10193489422818, UDI/DI (CS) 40193489422819; wwww) Model Number DYNJ908752, UDI/DI (EA) 10195327171360, UDI/DI (CS) 40195327171361; xxxx) Model Number DYNJRA0585, UDI/DI (EA) 10888277580695, UDI/DI (CS) 40888277580696; yyyy) Model Number DYNJRA1155B, UDI/DI (EA) 10193489583717, UDI/DI (CS) 40193489583718; zzzz) Model Number DYNJRA1578, UDI/DI (EA) 10193489272789, UDI/DI (CS) 40193489272780;