Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320; b) CENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A; c) TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1490A; d) TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1495A; e) CENTRAL VENOUS CATHETER BNDLE KIT, Model Number ECVC1725; f) INTRODUCER/INTROFLEX BUNDLE KIT (P/S), Model Number ECVC1915; g) 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC1970B; h) CVC BUNDLE KIT 20CM, Model Number ECVC2001; i) 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC2205A; j) CVC BUNDLE KIT 16CM, Model Number ECVC2240A; k) FIRST HEALTH 16CM QUAD LUMEN KIT, Model Number ECVC2320; l) 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC2440B; m) 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2555; n) 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2560; o) FIRST HEALTH 20CM QUAD LUMEN TRAY, Model Number ECVC2720; p) CENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number ECVC2745; q) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number ECVC2750; r) 7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number ECVC2770; s) CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number ECVC2895; t) SHEATH INTRODUCER BUNDLE, Model Number ECVC2930; u) DUAL INSERTION CVC + SHEATH BUNDLE, Model Number ECVC2940; v) TRIPLE LUMEN BUNDLE, Model Number ECVC2965; w) TRIPLE LUMEN BUNDLE, Model Number ECVC3155; x) CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number ECVC3285A; y) CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number ECVC3286; z) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3355; aa) TRIPLE LUMEN BUNDLE, 20CM, Model Number ECVC3395; bb) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3460; cc) 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number ECVC3505; dd) 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC3545; ee) TRIPLE LUMEN CVC INSERT BNDL 20CM, Model Number ECVC3735A; ff) CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number ECVC3755A; gg) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3785; hh) MULTI-LUMEN CVC INSERTION BUNDLE, Model Number ECVC3900; ii) QUAD LUMEN CVC INSERTION BUNDLE, Model Number ECVC4135; jj) AVA HIGH FLOW BUNDLE, Model Number ECVC4300; kk) 20CM 7F CVC INSERTION TRAY, Model Number ECVC4335; ll) OLEAN GENERAL CVC BUNDLE, Model Number ECVC4615; mm) 3L 7FR 16CM CVC INSERTION BUNDLE, Model Number ECVC4635A; nn) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number ECVC4640A; oo) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC4880; pp) DUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number ECVC4985; qq) QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number ECVC4995; rr) 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number ECVC5010A; ss) TRIPLE LUMEN BUNDLE W/MULTIMED CATH, Model Number ECVC5015; tt) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020; uu) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020A; vv) VANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number ECVC5080; ww) 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number ECVC5135B; xx) TRIPLE LUMEN COMPLETE CATH KIT, Model Number ECVC5200; yy) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5270; zz) CVC INSERTION BUNDLE - VANTEX, Model Number ECVC5310; aaa) CVC INSERTION BUNDLE - MULTIMED, Model Number ECVC5315; bbb) TRIPLE LUMEN CVC BUNDLE, Model Number ECVC5355B; ccc) CVC ZONE DEFENSE BUNDLE, Model Number ECVC5385; ddd) TRIPLE LUMEN BUNDLE, Model Number ECVC5475; eee) 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number ECVC5480; fff) CVC INSERTION MAX BUNDLE 20CM, Model Number ECVC5525A; ggg) CNTRL VENOUS CATH. INSERTION BNDL P/I, Model Number ECVC5530A; hhh) CVC BUNDLE TRIPLE LUMEN 16CM, Model Number ECVC5540A; iii) CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number ECVC5560A; jjj) CVC DOUBLE LUMEN 16CM, Model Number ECVC5585B; kkk) CVC TRIPLE LUMEN 16CM, Model Number ECVC5590B; lll) PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number ECVC5650;
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 ECVC1320: UDI/DI (EA) 10653160335795, UDI/DI (CS) 00653160335798; b) Model number ECVC1345A: UDI/DI (EA) 10653160334606, UDI/DI (CS) 00653160334609; c) Model number ECVC1490A: UDI/DI (EA) 10653160359036, UDI/DI (CS) 00653160359039; d) Model number ECVC1495A: UDI/DI (EA) 10653160358794, UDI/DI (CS) 00653160358797; e) Model number ECVC1725: UDI/DI (EA) 10653160334507, UDI/DI (CS) 00653160334500; f) Model number ECVC1915: UDI/DI (EA) 10653160334446, UDI/DI (CS) 00653160334449; g) Model number ECVC1970B: UDI/DI (EA) 10653160357155, UDI/DI (CS) 00653160357158; h) Model number ECVC2001: UDI/DI (EA) 10653160334415, UDI/DI (CS) 00653160334418; i) Model number ECVC2205A: UDI/DI (EA) 10653160357148, UDI/DI (CS) 00653160357141; j) Model number ECVC2240A: UDI/DI (EA) 10653160334361, UDI/DI (CS) 00653160334364; k) Model number ECVC2320: UDI/DI (EA) 10653160332480, UDI/DI (CS) 00653160332483; l) Model number ECVC2440B: UDI/DI (EA) 10653160358930, UDI/DI (CS) 00653160358933; m) Model number ECVC2555: UDI/DI (EA) 10653160336570, UDI/DI (CS) 00653160336573; n) Model number ECVC2560: UDI/DI (EA) 10653160334286, UDI/DI (CS) 00653160334289; o) Model number ECVC2720: UDI/DI (EA) 10653160332657, UDI/DI (CS) 00653160332650; p) Model number ECVC2745: UDI/DI (EA) 10653160334224, UDI/DI (CS) 00653160334227; q) Model number ECVC2750: UDI/DI (EA) 10653160334217, UDI/DI (CS) 00653160334210; r) Model number ECVC2770: UDI/DI (EA) 10653160332671, UDI/DI (CS) 00653160332674; s) Model number ECVC2895: UDI/DI (EA) 10653160332725, UDI/DI (CS) 00653160332728; t) Model number ECVC2930: UDI/DI (EA) 10653160335368, UDI/DI (CS) 00653160335361; u) Model number ECVC2940: UDI/DI (EA) 10653160335351, UDI/DI (CS) 00653160335354; v) Model number ECVC2965: UDI/DI (EA) 10653160338611, UDI/DI (CS) 00653160338614; w) Model number ECVC3155: UDI/DI (EA) 10653160334132, UDI/DI (CS) 00653160334135; x) Model number ECVC3285A: UDI/DI (EA) 10653160358572, UDI/DI (CS) 00653160358575; y) Model number ECVC3286: UDI/DI (EA) 10653160358398, UDI/DI (CS) 00653160358391; z) Model number ECVC3355: UDI/DI (EA) 10653160333982, UDI/DI (CS) 00653160333985; aa) Model number ECVC3395: UDI/DI (EA) 10653160338635, UDI/DI (CS) 00653160338638; bb) Model number ECVC3460: UDI/DI (EA) 10653160332794, UDI/DI (CS) 00653160332797; cc) Model number ECVC3505: UDI/DI (EA) 10653160334767, UDI/DI (CS) 00653160334760; dd) Model number ECVC3545: UDI/DI (EA) 10653160334774, UDI/DI (CS) 00653160334777; ee) Model number ECVC3735A: UDI/DI (EA) 10653160334798, UDI/DI (CS) 00653160334791; ff) Model number ECVC3755A: UDI/DI (EA) 10653160334804, UDI/DI (CS) 00653160334807; gg) Model number ECVC3785: UDI/DI (EA) 10653160336006, UDI/DI (CS) 00653160336009; hh) Model number ECVC3900: UDI/DI (EA) 10653160334828, UDI/DI (CS) 00653160334821; ii) Model number ECVC4135: UDI/DI (EA) 10653160335900, UDI/DI (CS) 00653160335903; jj) Model number ECVC4300: UDI/DI (EA) 10653160334873, UDI/DI (CS) 00653160334876; kk) Model number ECVC4335: UDI/DI (EA) 10653160357285, UDI/DI (CS) 00653160357288; ll) Model number ECVC4615: UDI/DI (EA) 10653160336075, UDI/DI (CS) 00653160336078; mm) Model number ECVC4635A: UDI/DI (EA) 10653160352112, UDI/DI (CS) 00653160352115; nn) Model number ECVC4640A: UDI/DI (EA) 10653160352105, UDI/DI (CS) 00653160352108; oo) Model number ECVC4880: UDI/DI (EA) 10653160333111, UDI/DI (CS) 00653160333114; pp) Model number ECVC4985: UDI/DI (EA) 10653160335269, UDI/DI (CS) 00653160335262; qq) Model number ECVC4995: UDI/DI (EA) 10653160335283, UDI/DI (CS) 00653160335286; rr) Model number ECVC5010A: UDI/DI (EA) 10653160335290, UDI/DI (CS) 00653160335293; ss) Model number ECVC5015: UDI/DI (EA) 10653160338956, UDI/DI (CS) 00653160338959; tt) Model number ECVC5020: UDI/DI (EA) 10653160334903, UDI/DI (CS) 00653160334906; uu) Model number ECVC5020A: UDI/DI (EA) 10653160358251, UDI/DI (CS) 00653160358254; vv) Model number ECVC5080: UDI/DI (EA) 10653160337690, UDI/DI (CS) 00653160337693; ww) Model number ECVC5135B: UDI/DI (EA) 10653160353652, UDI/DI (CS) 00653160353655; xx) Model number ECVC5200: UDI/DI (EA) 10653160336150, UDI/DI (CS) 00653160336153; yy) Model number ECVC5270: UDI/DI (EA) 10653160336198, UDI/DI (CS) 00653160336191; zz) Model number ECVC5310: UDI/DI (EA) 10653160336211, UDI/DI (CS) 00653160336214; aaa) Model number ECVC5315: UDI/DI (EA) 10653160339465, UDI/DI (CS) 00653160339468; bbb) Model number ECVC5355B: UDI/DI (EA) 10653160357742, UDI/DI (CS) 00653160357745; ccc) Model number ECVC5385: UDI/DI (EA) 10653160336518, UDI/DI (CS) 00653160336511; ddd) Model number ECVC5475: UDI/DI (EA) 10653160338116, UDI/DI (CS) 00653160338119; eee) Model number ECVC5480: UDI/DI (EA) 10653160339458, UDI/DI (CS) 00653160339451; fff) Model number ECVC5525A: UDI/DI (EA) 10653160338130, UDI/DI (CS) 00653160338133; ggg) Model number ECVC5530A: UDI/DI (EA) 10653160345596, UDI/DI (CS) 00653160345599; hhh) Model number ECVC5540A: UDI/DI (EA) 10653160335009, UDI/DI (CS) 00653160335002; iii) Model number ECVC5560A: UDI/DI (EA) 10653160336501, UDI/DI (CS) 00653160336504; jjj) Model number ECVC5585B: UDI/DI (EA) 10653160357711, UDI/DI (CS) 00653160357714; kkk) Model number ECVC5590B: UDI/DI (EA) 10653160357728, UDI/DI (CS) 00653160357721; lll) Model number ECVC5650: UDI/DI (EA) 10653160336457, UDI/DI (CS) 00653160336450; mmm) Model number ECVC5655: UDI/DI (EA) 10653160337621, UDI/DI (CS) 00653160337624; nnn) Model number ECVC5660: UDI/DI (EA) 10653160337638, UDI/DI (CS) 00653160337631; ooo) Model number ECVC5665: UDI/DI (EA) 10653160341505, UDI/DI (CS) 00653160341508; ppp) Model number ECVC5810: UDI/DI (EA) 10653160336419, UDI/DI (CS) 00653160336412; qqq) Model number ECVC5815: UDI/DI (EA) 10653160336402, UDI/DI (CS) 00653160336405; rrr) Model number ECVC5855B: UDI/DI (EA) 10653160355113, UDI/DI (CS) 00653160355116; sss) Model number ECVC5870A: UDI/DI (EA) 10653160338383, UDI/DI (CS) 00653160338386; ttt) Model number ECVC5985B: UDI/DI (EA) 10653160357797, UDI/DI (CS) 00653160357790; uuu) Model number ECVC6015B: UDI/DI (EA) 10653160357704, UDI/DI (CS) 00653160357707; vvv) Model number ECVC6070: UDI/DI (EA) 10653160335863, UDI/DI (CS) 00653160335866; www) Model number ECVC6075: UDI/DI (EA) 10653160338437, UDI/DI (CS) 00653160338430; xxx) Model number ECVC6120: UDI/DI (EA) 10653160336532, UDI/DI (CS) 00653160336535; yyy) Model number ECVC6255: UDI/DI (EA) 10653160336525, UDI/DI (CS) 00653160336528; zzz) Model number ECVC6260: UDI/DI (EA) 10653160336488, UDI/DI (CS) 00653160336481; aaaa) Model number ECVC6265: UDI/DI (EA) 10653160342922, UDI/DI (CS) 00653160342925; bbbb) Model number ECVC6340A: UDI/DI (EA) 10653160355038, UDI/DI (CS) 00653160355031; cccc) Model number ECVC6355: UDI/DI (EA) 10653160336396, UDI/DI (CS) 00653160336399; dddd) Model number ECVC6370: UDI/DI (EA) 10653160333425, UDI/DI (CS) 00653160333428; eeee) Model number ECVC6490A: UDI/DI (EA) 10653160344360, UDI/DI (CS) 00653160344363; ffff) Model number ECVC6505: UDI/DI (EA) 10653160336327, UDI/DI (CS) 00653160336320; gggg) Model number ECVC6540: UDI/DI (EA) 10653160339397, UDI/DI (CS) 00653160339390; hhhh) Model number ECVC6550: UDI/DI (EA) 10653160335276, UDI/DI (CS) 00653160335279; iiii) Model number ECVC6555: UDI/DI (EA) 10653160336341, UDI/DI (CS) 00653160336344; jjjj) Model number ECVC6585A: UDI/DI (EA) 10653160338826, UDI/DI (CS) 00653160338829; kkkk) Model number ECVC6595: UDI/DI (EA) 10653160337485, UDI/DI (CS) 00653160337488; llll) Model number ECVC6655A: UDI/DI (EA) 10653160339267, UDI/DI (CS) 00653160339260; mmmm) Model number ECVC6680A: UDI/DI (EA) 10653160337164, UDI/DI (CS) 00653160337167; nnnn) Model number ECVC6690: UDI/DI (EA) 10653160336600, UDI/DI (CS) 00653160336603; oooo) Model number ECVC6765: UDI/DI (EA) 10653160336839, UDI/DI (CS) 00653160336832; pppp) Model number ECVC6800: UDI/DI (EA) 10653160335092, UDI/DI (CS) 00653160335095; qqqq) Model number ECVC6800A: UDI/DI (EA) 10653160355694, UDI/DI (CS) 00653160355697; rrrr) Model number ECVC6815: UDI/DI (EA) 10653160335115, UDI/DI (CS) 00653160335118; ssss) Model number ECVC6825A: UDI/DI (EA) 10653160336631, UDI/DI (CS) 00653160336634; tttt) Model number ECVC6835: UDI/DI (EA) 10653160336778, UDI/DI (CS) 00653160336771; uuuu) Model number ECVC6840: UDI/DI (EA) 10653160336761, UDI/DI (CS) 00653160336764; vvvv) Model number ECVC6845: UDI/DI (EA) 10653160339366, UDI/DI (CS) 00653160339369; wwww) Model number ECVC6850: UDI/DI (EA) 10653160338819, UDI/DI (CS) 00653160338812; xxxx) Model number ECVC6915: UDI/DI (EA) 10653160336723, UDI/DI (CS) 00653160336726; yyyy) Model number ECVC6920: UDI/DI (EA) 10653160336716, UDI/DI (CS) 00653160336719; zzzz) Model number ECVC6970: UDI/DI (EA) 10653160336693, UDI/DI (CS) 00653160336696