{
  "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-2306-2023",
      "product_description": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. SHY IR PICC PACK, Model Number: DYNJ57112;       b. STANDARD PICC II-LF, Model Number: DYNJSPICC2, PICCNC002;     c. SUPERFICAL VENOUS PROCEDURE, Model Number: DYNJ82989;       d. SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267;       e. TV IR PICC PACK-LF, Model Number: DYNJ41561D;       f. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635A;       g. ULTRASOUND GUIDED PIV KIT, Model Number: DYNDA2669;       h. USG PIV INSERTION KIT, Model Number: DYNDV2480;       i. VASCULAR, Model Number: DYNJ907965;       j. VASCULAR ACCESS, Model Number: DYNJ901340A;       k. VASCULAR ACCESS TRAY, Model Number: DYNJ52606B;       l. VASCULAR ACCESS-LF, Model Number: DYNJ905285D;       m. VASCULAR ENDO LASER PK, Model Number: DYNJ37445G;       n. VASCULAR PACK, Model Number: DYNJ66356F;       o. VASCULAR VEIN PACK, Model Number: DYNJ69769;       p. VEIN ABLATION, Model Number: DYNJ63268C, DYNJ63268D, DYNJ66079A;       q. VEIN ABLATION KIT, Model Number: DYNJ69272;       r. VEIN ABLATION PACK, Model Number: DYNJ62889A, DYNJ62889B, DYNJ69288;       s. VEIN ABLATION PLUS W CHL, Model Number: DYNJ67115A;       t. VEIN CLOSURE, Model Number: DYNJ49180A;       u. VEIN CLOSURE PACK, Model Number: DYNJ69976, DYNJ69976A, DYNJ81834;       v. VEIN CLOSURE TRAY - NIVC, Model Number: DYNJ44737C;       w. VEIN HARVESTING PACK, Model Number: DYNJ82933;       x. VEIN LIGATION, Model Number: DYNJ64190B;       y. VEIN OHH, Model Number: DYNJ65560C;       z. VEIN PACK, Model Number: DYNJ66743B, DYNJ69091A, DYNJ69091B, DYNJ69177, DYNJ69942, DYNJ69942A, DYNJ81120, DYNJ81212A, DYNJ83914;       aa. VEIN PACK-LF, Model Number: DYNJ66271B, DYNJ66271D;       bb. VEIN PROCEDURE PACK, Model Number: DYNJ62038B, DYNJ81177;       cc. VEIN PROCEDURE TRAY, Model Number: DYNJ82581;       dd. VENCLOSE PROCEDURE PACK  7CM, Model Number: VC-PPH-6F7A;       ee. VENCLOSE PROCEDURE PACK MAVEN, Model Number: VC-PPM-12F;       ff. VENCLOSE PROCEDURE PACK, 12CM, Model Number: VC-PP-6F12, VC-PPH-6F12A;       gg. VENOUS ABLATION, Model Number: DYNJ44904B, DYNJ44904C;       hh. VENOUS ACCESS, Model Number: DYNJ59751B;       ii. VENOUS ACCESS PACK, Model Number: DYNJ44421B;       jj. VENOUS ACCESS TRAY, Model Number: DYNJ20094L;       kk. VENOUS LIGATION PACK, Model Number: DYNJ43981G;       ll. VENOUS PACK, Model Number: DYNJ43168, DYNJ43168A, DYNJ43168B, DYNJ56260A, DYNJ56447B, DYNJ62711A, DYNJ66499A, DYNJ66499B, DYNJ80169, DYNJ80169A, DYNJ80692;       mm. VNUS PACK, Model Number: DYNJ59246A;       nn. WEST VALLEY PICC LINE PACK, Model Number: DYNJ43975A;",
      "product_quantity": "148,445 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: DYNJ57112, UPC Number: 088994272159.   b. Model Number: DYNJSPICC2, UPC Number: 019348926312; Model Number: PICCNC002, UPC Number: 019348987719.   c. Model Number: DYNJ82989, UPC Number: 019532722176.   d. Model Number: DYNJ81267, UPC Number: 019532710144.   e. Model Number: DYNJ41561D, UPC Number: 088994281163.   f. Model Number: IVS3635A, UPC Number: 019348936055.   g. Model Number: DYNDA2669, UPC Number: 019348946542.   h. Model Number: DYNDV2480, UPC Number: 019348994276.   i. Model Number: DYNJ907965, UPC Number: 019348995225.   j. Model Number: DYNJ901340A, UPC Number: 088994217977.   k. Model Number: DYNJ52606B, UPC Number: 088827776311.   l. Model Number: DYNJ905285D, UPC Number: 019532706266.   m. Model Number: DYNJ37445G, UPC Number: 019348956435.   n. Model Number: DYNJ66356F, UPC Number: 019532716001.   o. Model Number: DYNJ69769, UPC Number: 019348997779.   p. Model Number: DYNJ63268C, UPC Number: 019532707716; Model Number: DYNJ63268D, UPC Number: 019532713221; Model Number: DYNJ66079A, UPC Number: 019348992307.   q. Model Number: DYNJ69272, UPC Number: 019348992033.   r. Model Number: DYNJ62889A, UPC Number: 019348997112; Model Number: DYNJ62889B, UPC Number: 019532703095; Model Number: DYNJ69288, UPC Number: 019348992267.   s. Model Number: DYNJ67115A, UPC Number: 019532709188.   t. Model Number: DYNJ49180A, UPC Number: 088827786356.   u. Model Number: DYNJ69976, UPC Number: 019532700130; Model Number: DYNJ69976A, UPC Number: 019532713039; Model Number: DYNJ81834, UPC Number: 019532714785.   v. Model Number: DYNJ44737C, UPC Number: 019532727787.   w. Model Number: DYNJ82933, UPC Number: 019532721933.   x. Model Number: DYNJ64190B, UPC Number: 019532728128.   y. Model Number: DYNJ65560C, UPC Number: 019532713681.   z. Model Number: DYNJ66743B, UPC Number: 019348994979, Model Number: DYNJ69091A, UPC Number: 019348996976, Model Number: DYNJ69091B, UPC Number: 019532717899, Model Number: DYNJ69177, UPC Number: 019348990219, Model Number: DYNJ69942, UPC Number: 019348999843, Model Number: DYNJ69942A, UPC Number: 019532728462, Model Number: DYNJ81120, UPC Number: 019532708588, Model Number: DYNJ81212A, UPC Number: 019532715986, Model Number: DYNJ83914, UPC Number: 019532731312.   aa. Model Number: DYNJ66271B, UPC Number: 019348999891; Model Number: DYNJ66271D, UPC Number: 019532713074.   bb. Model Number: DYNJ62038B, UPC Number: 019348989849; Model Number: DYNJ81177, UPC Number: 019532708961.   cc. Model Number: DYNJ82581, UPC Number: 019532719865.   dd. Model Number: VC-PPH-6F7A, UPC Number: 019348942309.   ee. Model Number: VC-PPM-12F, UPC Number: 019348942268.   ff. Model Number: VC-PP-6F12, UPC Number: 019348957665; Model Number: VC-PPH-6F12A, UPC Number: 019348942310.   gg. Model Number: DYNJ44904B, UPC Number: 019348969532; Model Number: DYNJ44904C, UPC Number: 019348985867.   hh. Model Number: DYNJ59751B, UPC Number: 019348969591.    ii. Model Number: DYNJ44421B, UPC Number: 088994220519.   jj. Model Number: DYNJ20094L, UPC Number: 019532721290.   kk. Model Number: DYNJ43981G, UPC Number: 019348922353.   ll. Model Number: DYNJ43168, UPC Number: 088827703489; Model Number: DYNJ43168A, UPC Number: 019532708470; Model Number: DYNJ43168B, UPC Number: 019532722452; Model Number: DYNJ56260A, UPC Number: 088994275590; Model Number: DYNJ56447B, UPC Number: 019348946406; Model Number: DYNJ62711A, UPC Number: 019348923301; Model Number: DYNJ66499A, UPC Number: 019348997752; Model Number: DYNJ66499B, UPC Number: 019532724210; Model Number: DYNJ80169, UPC Number: 019532701344; Model Number: DYNJ80169A, UPC Number: 019532716974; Model Number: DYNJ80692, UPC Number: 019532706554.   mm. Model Number: DYNJ59246A, UPC Number: 019532703911.   nn. Model Number: DYNJ43975A, UPC Number: 088827788244."
    }
  ]
}