Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R; b) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C; c) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D; d) ANGIOGRAM, Model Number DYNJ0149444N; e) DIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G; f) PICC LINE PACK-LF, Model Number DYNJ0275614F; g) ANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M; h) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233V; i) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233W; j) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233X; k) ANGIO PACK-LF, Model Number DYNJ0407399P; l) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535AA; m) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121K; n) CARDIAC EP PACK-LF, Model Number DYNJ0429185L; o) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0458661C; p) LT HEART/ANGIOGRAPHY PACK-LF, Model Number DYNJ0537652AG; q) CATH LAB ANGIO PACK-LF, Model Number DYNJ0545064AA; r) SPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508R; s) CARDIAC CATH PACK-LF, Model Number DYNJ0842644F; t) PEDIATRIC CATH PACK-LF, Model Number DYNJ0843244K; u) ANGIOGRAPHY PACK-LF, Model Number DYNJ0854485V; v) CARDIAC CATH PACK-LF, Model Number DYNJ0855138P; w) CARDIAC CATH PACK-LF, Model Number DYNJ0855138Q; x) IR PICC PACK-LF, Model Number DYNJ0950839C; y) SPECIAL PROCEDURES, Model Number DYNJ23288C; z) ANGIO TRAY, Model Number DYNJ23438M; aa) ADULT CARDIAC CATH PACK, Model Number DYNJ23455K; bb) ADULT CARDIAC CATH PACK, Model Number DYNJ23455L; cc) ADULT CARDIAC CATH PACK, Model Number DYNJ23455M; dd) ADULT CARDIAC CATH PACK, Model Number DYNJ23455N; ee) STENT PACK-LF, Model Number DYNJ27613K; ff) CATH I W/ ANGIO DRAPE, Model Number DYNJ33709F; gg) JUGULAR PACK, Model Number DYNJ35164C; hh) ANGIO DRAPE PACK RADIOLOGY-LF, Model Number DYNJ35993F; ii) ANGIO DRAPE II-LF, Model Number DYNJ35994C; jj) ANGIO/PICC PACK, Model Number DYNJ36049A; kk) ISSAQUA CATH/IR PACK, Model Number DYNJ36738G; ll) IR PACK, Model Number DYNJ36752B; mm) ARTERIOGRAM TRAY-LF, Model Number DYNJ36807C; nn) SPECIAL PROCEDURE PACK, Model Number DYNJ38314G; oo) MINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326G; pp) CARDIAC CATH PACK, Model Number DYNJ38866F; qq) INTERVENTIONAL RAD L J-LF, Model Number DYNJ40215B; rr) ABLATION PACK, Model Number DYNJ40629C; ss) CATH LAB PACK, Model Number DYNJ40926A; tt) RADIOLOGY PACK, Model Number DYNJ41190; uu) TV IR PACK-LF, Model Number DYNJ41562F; vv) CUSTOM ANGIO TRAY, Model Number DYNJ41649G; ww) CARDIAC CATH DRAPE PACK, Model Number DYNJ41700A; xx) IR PACK, Model Number DYNJ41989G; yy) INTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ42231C; zz) ANGIO PACK, Model Number DYNJ42903C; aaa) ANGIO PACK, Model Number DYNJ42903D; bbb) CARDIAC CATH PACK-LF, Model Number DYNJ42996C; ccc) DIALYSIS TRAY, Model Number DYNJ43060B; ddd) ANGIOPLASTY PACK-LF, Model Number DYNJ43203G; eee) ARTERIOGRAM PACK, Model Number DYNJ43261J; fff) CATH LAB RIGHT HEART PACK, Model Number DYNJ43315L; ggg) ANGIO CATH COMBINED PACK, Model Number DYNJ43609P; hhh) ANGIO CATH COMBINED PACK, Model Number DYNJ43609R; iii) ANGIO CATH COMBINED PACK, Model Number DYNJ43609S; jjj) ANGIO PACK, Model Number DYNJ43661C; kkk) ABLATION EP PACK, Model Number DYNJ43851B; lll) PK, RADIOLOGY, Model Number DYNJ43894B; mmm) PK, RADIOLOGY, Model Number DYNJ44087A; nnn) ANGIOGRAPHY PACK, Model Number DYNJ44293F; ooo) ANGIO DRAPE PACK, Model Number DYNJ44320G; ppp) ANGIO DRAPE PACK, Model Number DYNJ44320I; qqq) ANGIO DRAPE PACK, Model Number DYNJ44320J; rrr) FEMORAL ANGIO PACK, Model Number DYNJ44334M; sss) FEMORAL ANGIO PACK, Model Number DYNJ44334N; ttt) RADIOLOGY PACK, Model Number DYNJ44524F; uuu) ANGIO PACK, Model Number DYNJ44642B; vvv) ANGIOPLASTY PACK, Model Number DYNJ44700J; www) ANGIO PACK, Model Number DYNJ44993J; xxx) ANGIOGRAPHY PACK, Model Number DYNJ45059B; yyy) PERCUTANEOUS PACK, Model Number D
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 00-400305R, UDI/DI (EA) 10193489944280, UDI/DI (CS) 40193489944281; b) Model Number DYNJ0037936C, UDI/DI (EA) 10195327031282, UDI/DI (CS) 40195327031283; c) Model Number DYNJ0037936D, UDI/DI (EA) 10195327129538, UDI/DI (CS) 40195327129539; d) Model Number DYNJ0149444N, UDI/DI (EA) 10193489966718, UDI/DI (CS) 40193489966719; e) Model Number DYNJ0198765G, UDI/DI (EA) 10889942053988, UDI/DI (CS) 40889942053989; f) Model Number DYNJ0275614F, UDI/DI (EA) 10889942174348, UDI/DI (CS) 40889942174349; g) Model Number DYNJ0290716M, UDI/DI (EA) 10195327088866, UDI/DI (CS) 40195327088867; h) Model Number DYNJ0313233V, UDI/DI (EA) 10889942247356, UDI/DI (CS) 40889942247357; i) Model Number DYNJ0313233W, UDI/DI (EA) 10195327110970, UDI/DI (CS) 40195327110971; j) Model Number DYNJ0313233X, UDI/DI (EA) 10195327250980, UDI/DI (CS) 40195327250981; k) Model Number DYNJ0407399P, UDI/DI (EA) 10195327336868, UDI/DI (CS) 40195327336869; l) Model Number DYNJ0416535AA, UDI/DI (EA) 10195327354596, UDI/DI (CS) 40195327354597; m) Model Number DYNJ0429121K, UDI/DI (EA) 10195327069506, UDI/DI (CS) 40195327069507; n) Model Number DYNJ0429185L, UDI/DI (EA) 10195327048976, UDI/DI (CS) 40195327048977; o) Model Number DYNJ0458661C, UDI/DI (EA) 10889942550944, UDI/DI (CS) 40889942550945; p) Model Number DYNJ0537652AG, UDI/DI (EA) 10195327017675, UDI/DI (CS) 40195327017676; q) Model Number DYNJ0545064AA, UDI/DI (EA) 10195327327385, UDI/DI (CS) 40195327327386; r) Model Number DYNJ0604508R, UDI/DI (EA) 10193489828443, UDI/DI (CS) 40193489828444; s) Model Number DYNJ0842644F, UDI/DI (EA) 10195327288600, UDI/DI (CS) 40195327288601; t) Model Number DYNJ0843244K, UDI/DI (EA) 10195327288594, UDI/DI (CS) 40195327288595; u) Model Number DYNJ0854485V, UDI/DI (EA) 10195327096885, UDI/DI (CS) 40195327096886; v) Model Number DYNJ0855138P, UDI/DI (EA) 10193489885132, UDI/DI (CS) 40193489885133; w) Model Number DYNJ0855138Q, UDI/DI (EA) 10195327094843, UDI/DI (CS) 40195327094844; x) Model Number DYNJ0950839C, UDI/DI (EA) 10889942101290, UDI/DI (CS) 40889942101291; y) Model Number DYNJ23288C, UDI/DI (EA) 10193489954142, UDI/DI (CS) 40193489954143; z) Model Number DYNJ23438M, UDI/DI (EA) 10193489970609, UDI/DI (CS) 40193489970600; aa) Model Number DYNJ23455K, UDI/DI (EA) 10193489446296, UDI/DI (CS) 40193489446297; bb) Model Number DYNJ23455L, UDI/DI (EA) 10193489977387, UDI/DI (CS) 40193489977388; cc) Model Number DYNJ23455M, UDI/DI (EA) 10195327129835, UDI/DI (CS) 40195327129836; dd) Model Number DYNJ23455N, UDI/DI (EA) 10195327237752, UDI/DI (CS) 40195327237753; ee) Model Number DYNJ27613K, UDI/DI (EA) 10195327131180, UDI/DI (CS) 40195327131181; ff) Model Number DYNJ33709F, UDI/DI (EA) 10889942713929, UDI/DI (CS) 40889942713920; gg) Model Number DYNJ35164C, UDI/DI (EA) 10889942494668, UDI/DI (CS) 40889942494669; hh) Model Number DYNJ35993F, UDI/DI (EA) 10195327398286, UDI/DI (CS) 40195327398287; ii) Model Number DYNJ35994C, UDI/DI (EA) 10195327397951, UDI/DI (CS) 40195327397952; jj) Model Number DYNJ36049A, UDI/DI (EA) 10195327147204, UDI/DI (CS) 40195327147205; kk) Model Number DYNJ36738G, UDI/DI (EA) 10195327054168, UDI/DI (CS) 40195327054169; ll) Model Number DYNJ36752B, UDI/DI (EA) 10195327226022, UDI/DI (CS) 40195327226023; mm) Model Number DYNJ36807C, UDI/DI (EA) 10195327082222, UDI/DI (CS) 40195327082223; nn) Model Number DYNJ38314G, UDI/DI (EA) 10193489603347, UDI/DI (CS) 40193489603348; oo) Model Number DYNJ38326G, UDI/DI (EA) 10195327230135, UDI/DI (CS) 40195327230136; pp) Model Number DYNJ38866F, UDI/DI (EA) 10193489914863, UDI/DI (CS) 40193489914864; qq) Model Number DYNJ40215B, UDI/DI (EA) 10888277912267, UDI/DI (CS) 40888277912268; rr) Model Number DYNJ40629C, UDI/DI (EA) 10193489997316, UDI/DI (CS) 40193489997317; ss) Model Number DYNJ40926A, UDI/DI (EA) 10195327137212, UDI/DI (CS) 40195327137213; tt) Model Number DYNJ41190, UDI/DI (EA) 10884389899083, UDI/DI (CS) 40884389899084; uu) Model Number DYNJ41562F, UDI/DI (EA) 10193489641080, UDI/DI (CS) 40193489641081; vv) Model Number DYNJ41649G, UDI/DI (EA) 10195327277291, UDI/DI (CS) 40195327277292; ww) Model Number DYNJ41700A, UDI/DI (EA) 10889942756957, UDI/DI (CS) 40889942756958; xx) Model Number DYNJ41989G, UDI/DI (EA) 10193489310801, UDI/DI (CS) 40193489310802; yy) Model Number DYNJ42231C, UDI/DI (EA) 10195327026561, UDI/DI (CS) 40195327026562; zz) Model Number DYNJ42903C, UDI/DI (EA) 10195327079666, UDI/DI (CS) 40195327079667; aaa) Model Number DYNJ42903D, UDI/DI (EA) 10195327171117, UDI/DI (CS) 40195327171118; bbb) Model Number DYNJ42996C, UDI/DI (EA) 10193489988437, UDI/DI (CS) 40193489988438; ccc) Model Number DYNJ43060B, UDI/DI (EA) 10889942765850, UDI/DI (CS) 40889942765851; ddd) Model Number DYNJ43203G, UDI/DI (EA) 10193489952919, UDI/DI (CS) 40193489952910; eee) Model Number DYNJ43261J, UDI/DI (EA) 10195327288792, UDI/DI (CS) 40195327288793; fff) Model Number DYNJ43315L, UDI/DI (EA) 10193489463675, UDI/DI (CS) 40193489463676; ggg) Model Number DYNJ43609P, UDI/DI (EA) 10193489914535, UDI/DI (CS) 40193489914536; hhh) Model Number DYNJ43609R, UDI/DI (EA) 10195327228781, UDI/DI (CS) 40195327228782; iii) Model Number DYNJ43609S, UDI/DI (EA) 10195327322984, UDI/DI (CS) 40195327322985; jjj) Model Number DYNJ43661C, UDI/DI (EA) 10195327104351, UDI/DI (CS) 40195327104352; kkk) Model Number DYNJ43851B, UDI/DI (EA) 10195327200329, UDI/DI (CS) 40195327200320; lll) Model Number DYNJ43894B, UDI/DI (EA) 10193489810486, UDI/DI (CS) 40193489810487; mmm) Model Number DYNJ44087A, UDI/DI (EA) 10889942561803, UDI/DI (CS) 40889942561804; nnn) Model Number DYNJ44293F, UDI/DI (EA) 10195327265182, UDI/DI (CS) 40195327265183; ooo) Model Number DYNJ44320G, UDI/DI (EA) 10193489966305, UDI/DI (CS) 40193489966306; ppp) Model Number DYNJ44320I, UDI/DI (EA) 10195327070359, UDI/DI (CS) 40195327070350; qqq) Model Number DYNJ44320J, UDI/DI (EA) 10195327132354, UDI/DI (CS) 40195327132355; rrr) Model Number DYNJ44334M, UDI/DI (EA) 10195327133115, UDI/DI (CS) 40195327133116; sss) Model Number DYNJ44334N, UDI/DI (EA) 10195327299491, UDI/DI (CS) 40195327299492; ttt) Model Number DYNJ44524F, UDI/DI (EA) 10193489467482, UDI/DI (CS) 40193489467483; uuu) Model Number DYNJ44642B, UDI/DI (EA) 10195327011420, UDI/DI (CS) 40195327011421; vvv) Model Number DYNJ44700J, UDI/DI (EA) 10195327277413, UDI/DI (CS) 40195327277414; www) Model Number DYNJ44993J, UDI/DI (EA) 10195327380922, UDI/DI (CS) 40195327380923; xxx) Model Number DYNJ45059B, UDI/DI (EA) 10889942135639, UDI/DI (CS) 40889942135630; yyy) Model Number DYNJ46035D, UDI/DI (EA) 10193489493641, UDI/DI (CS) 40193489493642; zzz) Model Number DYNJ46545B, UDI/DI (EA) 10195327008246, UDI/DI (CS) 40195327008247; aaaa) Model Number DYNJ46545C, UDI/DI (EA) 10195327250423, UDI/DI (CS) 40195327250424; bbbb) Model Number DYNJ47645B, UDI/DI (EA) 10193489952834, UDI/DI (CS) 40193489952835; cccc) Model Number DYNJ47646D, UDI/DI (EA) 10193489950472, UDI/DI (CS) 40193489950473; dddd) Model Number DYNJ47646F, UDI/DI (EA) 10195327155513, UDI/DI (CS) 40195327155514; eeee) Model Number DYNJ47646G, UDI/DI (EA) 10195327175023, UDI/DI (CS) 40195327175024; ffff) Model Number DYNJ47646I, UDI/DI (EA) 10195327357122, UDI/DI (CS) 40195327357123; gggg) Model Number DYNJ47665D, UDI/DI (EA) 10193489952827, UDI/DI (CS) 40193489952828; hhhh) Model Number DYNJ47665F, UDI/DI (EA) 10195327355210, UDI/DI (CS) 40195327355211; iiii) Model Number DYNJ49621C, UDI/DI (EA) 10195327008581, UDI/DI (CS) 40195327008582; jjjj) Model Number DYNJ50694A, UDI/DI (EA) 10889942693511, UDI/DI (CS) 40889942693512; kkkk) Model Number DYNJ50712D, UDI/DI (EA) 10195327267926, UDI/DI (CS) 40195327267927; llll) Model Number DYNJ51109B, UDI/DI (EA) 10889942456314, UDI/DI (CS) 40889942456315; mmmm) Model Number DYNJ51240A, UDI/DI (EA) 10889942493524, UDI/DI (CS) 40889942493525; nnnn) Model Number DYNJ51338C, UDI/DI (EA) 10193489241716, UDI/DI (CS) 40193489241717; oooo) Model Number DYNJ52000B, UDI/DI (EA) 10193489384987, UDI/DI (CS) 40193489384988; pppp) Model Number DYNJ52121A, UDI/DI (EA) 10195327260095, UDI/DI (CS) 40195327260096; qqqq) Model Number DYNJ52425J, UDI/DI (EA) 10193489940145, UDI/DI (CS) 40193489940146; rrrr) Model Number DYNJ52425K, UDI/DI (EA) 10195327042356, UDI/DI (CS) 40195327042357; ssss) Model Number DYNJ52425L, UDI/DI (EA) 10195327074487, UDI/DI (CS) 40195327074488; tttt) Model Number DYNJ52425M, UDI/DI (EA) 10195327177188, UDI/DI (CS) 40195327177189; uuuu) Model Number DYNJ52425N, UDI/DI (EA) 10195327339326, UDI/DI (CS) 40195327339327; vvvv) Model Number DYNJ52774, UDI/DI (EA) 10889942322473, UDI/DI (CS) 40889942322474; wwww) Model Number DYNJ52806C, UDI/DI (EA) 10193489292909, UDI/DI (CS) 40193489292900; xxxx) Model Number DYNJ53095, UDI/DI (EA) 10889942371778, UDI/DI (CS) 40889942371779; yyyy) Model Number DYNJ53481D, UDI/DI (EA) 10193489812572, UDI/DI (CS) 40193489812573; zzzz) Model Number DYNJ54755I, UDI/DI (EA) 10195327021269, UDI/DI (CS) 40195327021260