{
  "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": "92399",
      "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 the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.",
      "recall_number": "Z-2323-2023",
      "product_description": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482;     b. ARTERIAL LINE START KIT, Model Number: ART920;     c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810;    d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915;       e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770;       f. IV SECUREMENT KIT, Model Number: DYNDV2407A;       g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005;       h. MIDLINE INSERTION TRAY, Model Number: CVI4340;       i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011;       j. MIDLINE KIT 4F SL MB, Model Number: MID0001;       k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003;       l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A;       m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB;       n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765;       o. NEONATAL PICC LINE INSERTION TRAY, Model Number: DYNDC2120B;       p. NICU PICC TRAY, Model Number: CVI3740A;       q. PED ULTRASOUND GUIDED PIV, Model Number: IVS3990;       r. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450B;       s. PERIPHERAL ULTRASOUND CATHETER INSERTION, Model Number: DYNDV2285, MNS9865;       t. PICC BUNDLE 5FR DL, Model Number: PICC0013;       u. PICC INSERTION BUNDLE, Model Number: DT14560;       v. PICC INSERTION TRAY, Model Number: CVI3805, CVI3820;       w. PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB, PICC0010, PICC0011, PICC0012;       x. PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB;       y. PIV BSI KIT, Model Number: BSIPIV1010;       z. PIV KIT, Model Number: BSIPIV1004;       aa. POLY MIDLINE KIT 4F SL, Model Number: DYNJ68937A;       bb. QUINTEN CATH ACCESSORY KIT, Model Number: CVI3700;       cc. ULTRASOUND GUIDED IV KIT, Model Number: IVS3705, IVS3705A, IVS3905A;       dd. ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350;       ee. ULTRASOUND GUIDED IV START KIT, Model Number: DYNDV2465, DYNDV2518, DYNDV2547;       ff. ULTRASOUND GUIDED IV START KIT W/SHIELD, Model Number: BSIPIV1006;       gg. ULTRASOUND GUIDED IV/MIDLINE KIT, Model Number: DYNDV2385;       hh. ULTRASOUND GUIDED PIV, Model Number: IVS4075;       ii. ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG, Model Number: BSIPIV1011;       jj. ULTRASOUND GUIDED PIV INSERTION KIT, Model Number: IVS3485A, IVS3840, IVS3840A, IVS3940, IVS3940A, IVS3940B;       kk. ULTRASOUND GUIDED PIV KIT, Model Number: BSIPIV1005, DYNDA2669, IVS3300, IVS3420A, IVS3420B, IVS3495, IVS3505, IVS3655B, IVS3900, IVS3900A, IVS4005;     ll. ULTRASOUND GUIDED PIV START KIT, Model Number: IVS3715;       mm. ULTRASOUND IV START KIT, Model Number: IV8790;       nn. ULTRASOUND PIV BUNDLE, Model Number: IV8635A, IV8635B, IV8635C;       oo. ULTRASOUND PIV KIT, Model Number: IVS3970;       pp. UNIVERSAL BUNDLE-CENTRAL LINE PACK, Model Number: CVI3910;       qq. UNIVERSAL LINE INSERTION TRAY, Model Number: DT16125;       rr. USG IV START KIT, Model Number: DYNDV2435;       ss. USG PIV KIT, Model Number: DYNDV2536, DYNDV2567;       tt. USGPIV Insertion Kit, Model Number: MBSIULSGD01;       uu. USGPIV KIT, Model Number: DYNDV2578;       vv. USPIV KIT, Model Number: IVS3910;       ww. VAMC PICC PREP BUNDLE, Model Number: CVI3880;       xx. VANTEX 7FR 3L 16CM CVC INSERTION BNDL, Model Number: STCVC2020A;       yy. VANTEX 7FR 3L 20CM CVC INSERTION BNDL, Model Number: STCVC2015A;       zz. VI PACK, Model Number: DYNJ64871",
      "product_quantity": "218,163 kits",
      "reason_for_recall": "Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.",
      "recall_initiation_date": "20230515",
      "center_classification_date": "20230803",
      "report_date": "20230809",
      "code_info": "All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023:    a. Model Number: DYNDA2482, UPC Number: 10193489198188.   b. Model Number: ART920, UPC Number: 10653160327899.   c. Model Number: DT19810, UPC Number: 10653160285656.   d. Model Number: CVI4915, UPC Number: 10653160355489.   e. Model Number: IVS3770, UPC Number: 10653160328230.   f. Model Number: DYNDV2407A, UPC Number: 019348981701.   g. Model Number: MID0005, UPC Number: 10653160349181.   h. Model Number: CVI4340, UPC Number: 10653160309475.   i. Model Number: MIDST04011, UPC Number: 10653160350699.   j. Model Number: MID0001, UPC Number: 10193489381627.   k. Model Number: DYNJ80141MB, UPC Number: 10889942733415; Model Number: MID0003, UPC Number: 10653160349334.   l. Model Number: PICC0009A, UPC Number: 10193489760231.   m. Model Number: DYNJ80152MB, UPC Number: 10889942733422.   n. Model Number: DYNDA2509A, UPC Number: 10193489196986; Model Number: MNS8765, UPC Number: 10653160270515.   o. Model Number: DYNDC2120B, UPC Number: 10193489198270.   p. Model Number: CVI3740A, UPC Number: 10653160324416.   q. Model Number: IVS3990, UPC Number: 10653160345282.   r. Model Number: CVI4450B, UPC Number: 10653160358428.   s. Model Number: DYNDV2285, UPC Number: 10193489194548; Model Number: MNS9865, UPC Number: 10653160294436.   t. Model Number: PICC0013, UPC Number: 10653160351818.   u. Model Number: DT14560, UPC Number: 10653160236887.   v. Model Number: CVI3805, UPC Number: 10653160265085; Model Number: CVI3820, UPC Number: 10653160273509.   w. Model Number: DYNJ70141MB, UPC Number: 10889942722808; Model Number: PICC0010, UPC Number: 10653160349112; Model Number: PICC0011, UPC Number: 10653160350842; Model Number: PICC0012, UPC Number: 10653160350491.   x. Model Number: DYNJ70152MB, UPC Number: 10889942722822.   y. Model Number: BSIPIV1010, UPC Number: 10653160356523.   z. Model Number: BSIPIV1004, UPC Number: 10193489198843.   aa. Model Number: DYNJ68937A, UPC Number: 10193489111545.   bb. Model Number: CVI3700, UPC Number: 10653160259763.   cc. Model Number: IVS3705, UPC Number: 10653160325819; Model Number: IVS3705A, UPC Number: 10653160342885; Model Number: IVS3905A, UPC Number: 10653160344391.   dd. Model Number: IVS3350, UPC Number: 10653160313045.   ee. Model Number: DYNDV2465, UPC Number: 10193489110166; Model Number: DYNDV2518, UPC Number: 019532708907; Model Number: DYNDV2547, UPC Number: 10653160354246.   ff. Model Number: BSIPIV1006, UPC Number: 10653160356936.   gg. Model Number: DYNDV2385, UPC Number: 10193489195217.   hh. Model Number: IVS4075, UPC Number: 10653160350545.    ii. Model Number: BSIPIV1011, UPC Number: 10653160353317.   jj. Model Number: IVS3485A, UPC Number: 10653160328612; Model Number: IVS3840, UPC Number: 10653160341994; Model Number: IVS3840A, UPC Number: 10653160344612; Model Number: IVS3940, UPC Number: 10653160342304; Model Number: IVS3940A, UPC Number: 10653160345664; Model Number: IVS3940B, UPC Number: 10653160355335.   kk. Model Number: BSIPIV1005, UPC Number: 10193489198867; Model Number: DYNDA2669, UPC Number: 10193489191912; Model Number: IVS3300, UPC Number: 10653160307662; Model Number: IVS3420A, UPC Number: 10653160342205; Model Number: IVS3420B, UPC Number: 10653160359067; Model Number: IVS3495, UPC Number: 10653160316596; Model Number: IVS3505, UPC Number: 10653160323761; Model Number: IVS3655B, UPC Number: 10653160358107; Model Number: IVS3900, UPC Number: 10653160344810; Model Number: IVS3900A, UPC Number: 10653160347774; Model Number: IVS4005, UPC Number: 10653160346142.   ll. Model Number: IVS3715, UPC Number: 10653160326298.   mm. Model Number: IV8790, UPC Number: 019348936055.   nn. Model Number: IV8635A, UPC Number: 10653160324010; Model Number: IV8635B, UPC Number: 10653160327622; Model Number: IV8635C, UPC Number: 10653160344858.   oo. Model Number: IVS3970, UPC Number: 10653160343431.   pp. Model Number: CVI3910, UPC Number: 10653160272311.   qq. Model Number: DT16125, UPC Number: 10653160254751.   rr. Model Number: DYNDV2435, UPC Number: 019532704366.   ss. Model Number: DYNDV2536, UPC Number: 10653160353676; Model Number: DYNDV2567, UPC Number: 10653160356455.   tt. Model Number: MBSIULSGD01, UPC Number: 10193489199482.   uu. Model Number: DYNDV2578, UPC Number: 10653160358374.   vv. Model Number: IVS3910, UPC Number: 10653160338871.   ww. Model Number: CVI3880, UPC Number: 10653160272755.   xx. Model Number: STCVC2020A, UPC Number: 10653160350569.   yy. Model Number: STCVC2015A, UPC Number: 10653160350552.   zz. Model Number: DYNJ64871, UPC Number: 019348922536."
    }
  ]
}