{
  "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-2200-2023",
      "product_description": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tARTERIAL LINE START KIT , Model Number ART920;   b)\tULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005;   c)\tULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006;   d)\tPIV BSI KIT , Model Number BSIPIV1010;   e)\tULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG , Model Number BSIPIV1011;   f)\tPICC INSERTION TRAY , Model Number CVI3805;   g)\tPEDIATRIC PICC INSERTION TRAY , Model Number CVI4450B;   h)\tCENTRAL LINE INSERTION TRAY , Model Number DT19810;   i)\tNEONATAL PICC INSERTION TRAY , Model Number DYNDA2509A;   j)\tUSG PIV KIT , Model Number DYNDV2536;   k)\tULTRASOUND GUIDED IV START KIT , Model Number DYNDV2547;   l)\tUSG PIV KIT , Model Number DYNDV2567;   m)\tPOLY MIDLINE KIT 4F SL , Model Number DYNJ68937A;   n)\tPICC KIT 4F SL PL MAX BARRIER , Model Number DYNJ70141MB;   o)\tPICC KIT 5F DL PL MB , Model Number DYNJ70152MB;   p)\tMIDLINE KIT 4F SL PL MAX BARR , Model Number DYNJ80141MB;   q)\tMIDLINE KIT 5F DL PL MAX BARR , Model Number DYNJ80152MB;   r)\tULTRASOUND GUIDED PIV KIT , Model Number IVS3420B;   s)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3635C;   t)\tFLOOR ULTRASOUND GUIDED IV SECUREMENT , Model Number IVS3770;   u)\tULTRASOUND GUIDED PIV KIT , Model Number IVS3900A;   v)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940A;   w)\tULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940B;   x)\tULTRASOUND GUIDED PIV KIT , Model Number IVS4005;   y)\tMIDLINE KIT 4F SL MB , Model Number MID0001;   z)\tMIDLINE KIT 4F SL PL MAX BARR , Model Number MID0003;   aa)\tMIDLINE BUNDLE 4FR SL , Model Number MID0005;   bb)\tMIDLINE KIT 4F SL PL MB , Model Number PICC0009A;   cc)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0010;   dd)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0011;   ee)\tPICC KIT 4F SL PL MAX BARRIER , Model Number PICC0012;   ff)\tPICC BUNDLE 5FR DL , Model Number PICC0013;   gg)\tVANTEX 7FR 3L 20CM CVC INSERTION BNDL , Model Number STCVC2015A;   hh)\tVANTEX 7FR 3L 16CM CVC INSERTION BNDL , Model Number STCVC2020A;",
      "product_quantity": "70648 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 ART920, UDI/DI (EA) 10653160327899, UDI/DI (CS) 00653160327892;  b) Model Number BSIPIV1005, UDI/DI (EA) 10193489198867, UDI/DI (CS) 20193489198864;  c) Model Number BSIPIV1006, UDI/DI (EA) 10653160356936, UDI/DI (CS) 00653160356939;  d) Model Number BSIPIV1010, UDI/DI (EA) 10653160356523, UDI/DI (CS) 00653160356526;  e) Model Number BSIPIV1011, UDI/DI (EA) 10653160353317, UDI/DI (CS) 00653160353310;  f) Model Number CVI3805, UDI/DI (EA) 10653160265085, UDI/DI (CS) 00653160265088;  g) Model Number CVI4450B, UDI/DI (EA) 10653160358428, UDI/DI (CS) 00653160358421;  h) Model Number DT19810, UDI/DI (EA) 10653160285656, UDI/DI (CS) 00653160285659;  i) Model Number DYNDA2509A, UDI/DI (EA) 10193489196986, UDI/DI (CS) 20193489196983;  j) Model Number DYNDV2536, UDI/DI (EA) 10653160353676, UDI/DI (CS) 00653160353679;  k) Model Number DYNDV2547, UDI/DI (EA) 10653160354246, UDI/DI (CS) 00653160354249;  l) Model Number DYNDV2567, UDI/DI (EA) 10653160356455, UDI/DI (CS) 00653160356458;  m) Model Number DYNJ68937A, UDI/DI (EA) 10193489111545, UDI/DI (CS) 20193489111542;  n) Model Number DYNJ70141MB, UDI/DI (EA) 10889942722808, UDI/DI (CS) 20889942722805;  o) Model Number DYNJ70152MB, UDI/DI (EA) 10889942722822, UDI/DI (CS) 40889942722823;  p) Model Number DYNJ80141MB, UDI/DI (EA) 10889942733415, UDI/DI (CS) 20889942733412;  q) Model Number DYNJ80152MB, UDI/DI (EA) 10889942733422, UDI/DI (CS) 20889942733429;  r) Model Number IVS3420B, UDI/DI (EA) 10653160359067, UDI/DI (CS) 00653160359060;  s) Model Number IVS3635C, UDI/DI (EA) 10653160358954, UDI/DI (CS) 00653160358957;  t) Model Number IVS3770, UDI/DI (EA) 10653160328230, UDI/DI (CS) 00653160328233;  u) Model Number IVS3900A, UDI/DI (EA) 10653160347774, UDI/DI (CS) 00653160347777;  v) Model Number IVS3940A, UDI/DI (EA) 10653160345664, UDI/DI (CS) 00653160345667;  w) Model Number IVS3940B, UDI/DI (EA) 10653160355335, UDI/DI (CS) 00653160355338;  x) Model Number IVS4005, UDI/DI (EA) 10653160346142, UDI/DI (CS) 00653160346145;  y) Model Number MID0001, UDI/DI (EA) 10193489381627, UDI/DI (CS) 40193489381628;  z) Model Number MID0003, UDI/DI (EA) 10653160349334, UDI/DI (CS) 00653160349337;  aa) Model Number MID0005, UDI/DI (EA) 10653160349181, UDI/DI (CS) 00653160349184;  bb) Model Number PICC0009A, UDI/DI (EA) 10193489760231, UDI/DI (CS) 20193489760238;  cc) Model Number PICC0010, UDI/DI (EA) 10653160349112, UDI/DI (CS) 00653160349115;  dd) Model Number PICC0011, UDI/DI (EA) 10653160350842, UDI/DI (CS) 00653160350845;  ee) Model Number PICC0012, UDI/DI (EA) 10653160350491, UDI/DI (CS) 00653160350494;  ff) Model Number PICC0013, UDI/DI (EA) 10653160351818, UDI/DI (CS) 00653160351811;  gg) Model Number STCVC2015A, UDI/DI (EA) 10653160350552, UDI/DI (CS) 00653160350555;  hh) Model Number STCVC2020A, UDI/DI (EA) 10653160350569, UDI/DI (CS) 00653160350562",
      "more_code_info": ""
    }
  ]
}