{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Northfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92466",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "address_2": "N/A",
      "postal_code": "60093-2753",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.",
      "recall_number": "Z-2194-2023",
      "product_description": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)\tVANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320;  b)\tCENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A;  c)\tTRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1490A;  d)\tTRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1495A;  e)\tCENTRAL VENOUS CATHETER BNDLE KIT, Model Number ECVC1725;  f)\tINTRODUCER/INTROFLEX BUNDLE KIT (P/S), Model Number ECVC1915;  g)\t20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC1970B;  h)\tCVC BUNDLE KIT 20CM, Model Number ECVC2001;  i)\t16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC2205A;  j)\tCVC BUNDLE KIT 16CM, Model Number ECVC2240A;  k)\tFIRST HEALTH 16CM QUAD LUMEN KIT, Model Number ECVC2320;  l)\t7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC2440B;  m)\t16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2555;  n)\t20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2560;  o)\tFIRST HEALTH 20CM QUAD LUMEN TRAY, Model Number ECVC2720;  p)\tCENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number ECVC2745;  q)\tCENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number ECVC2750;  r)\t7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number ECVC2770;  s)\tCVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number ECVC2895;  t)\tSHEATH INTRODUCER BUNDLE, Model Number ECVC2930;  u)\tDUAL INSERTION CVC + SHEATH BUNDLE, Model Number ECVC2940;  v)\tTRIPLE LUMEN BUNDLE, Model Number ECVC2965;  w)\tTRIPLE LUMEN BUNDLE, Model Number ECVC3155;  x)\tCVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number ECVC3285A;  y)\tCVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number ECVC3286;  z)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3355;  aa)\tTRIPLE LUMEN BUNDLE, 20CM, Model Number ECVC3395;  bb)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3460;  cc)\t20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number ECVC3505;  dd)\t7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC3545;  ee)\tTRIPLE LUMEN CVC INSERT BNDL 20CM, Model Number ECVC3735A;  ff)\tCVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number ECVC3755A;  gg)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3785;  hh)\tMULTI-LUMEN CVC INSERTION BUNDLE, Model Number ECVC3900;  ii)\tQUAD LUMEN CVC INSERTION BUNDLE, Model Number ECVC4135;  jj)\tAVA HIGH FLOW BUNDLE, Model Number ECVC4300;  kk)\t20CM 7F CVC INSERTION TRAY, Model Number ECVC4335;  ll)\tOLEAN GENERAL CVC BUNDLE, Model Number ECVC4615;  mm)\t3L 7FR 16CM CVC INSERTION BUNDLE, Model Number ECVC4635A;  nn)\t3L 7FR 20CM CVC INSERTION BUNDLE, Model Number ECVC4640A;  oo)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC4880;  pp)\tDUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number ECVC4985;  qq)\tQUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number ECVC4995;  rr)\t16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number ECVC5010A;  ss)\tTRIPLE LUMEN BUNDLE W/MULTIMED CATH, Model Number ECVC5015;  tt)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020;  uu)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020A;  vv)\tVANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number ECVC5080;  ww)\t20CM 3L 7FR CVC INSERTION BUNDLE, Model Number ECVC5135B;  xx)\tTRIPLE LUMEN COMPLETE CATH KIT, Model Number ECVC5200;  yy)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5270;  zz)\tCVC INSERTION BUNDLE - VANTEX, Model Number ECVC5310;  aaa)\tCVC INSERTION BUNDLE - MULTIMED, Model Number ECVC5315;  bbb)\tTRIPLE LUMEN CVC BUNDLE, Model Number ECVC5355B;  ccc)\tCVC ZONE DEFENSE BUNDLE, Model Number ECVC5385;  ddd)\tTRIPLE LUMEN BUNDLE, Model Number ECVC5475;  eee)\t7F, 16cm, 3L  MAX BARRIER CVC BUNDLE, Model Number ECVC5480;  fff)\tCVC INSERTION MAX BUNDLE 20CM, Model Number ECVC5525A;  ggg)\tCNTRL VENOUS CATH. INSERTION BNDL P/I, Model Number ECVC5530A;  hhh)\tCVC BUNDLE TRIPLE LUMEN 16CM, Model Number ECVC5540A;  iii)\tCVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number ECVC5560A;  jjj)\tCVC DOUBLE LUMEN 16CM, Model Number ECVC5585B;  kkk)\tCVC TRIPLE LUMEN 16CM, Model Number ECVC5590B;  lll)\tPI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number ECVC5650;",
      "product_quantity": "10080 units",
      "reason_for_recall": "Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.",
      "recall_initiation_date": "20230518",
      "center_classification_date": "20230720",
      "report_date": "20230726",
      "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",
      "more_code_info": ""
    }
  ]
}