{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Northfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93800",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "address_2": "",
      "postal_code": "60093-2753",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama",
      "recall_number": "Z-1128-2024",
      "product_description": "Medline Kits, trays, and packs labeled as follows:    a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470;   b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471;   c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442;   d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472;   e) KIT,SUCTION CATH,18FR W/H20, REF DYND41474;   f) KIT,SUCTION CATH,6FR,DELEE,W/H, REF DYND41476;   g) KIT,SUCTION CATH,8FR DELEE W/H, REF DYND41478;   h) KIT,SUCTION CATHETER,14FR W/S, REF DYND41442",
      "product_quantity": "1,012,700 units",
      "reason_for_recall": "Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components):  0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.",
      "recall_initiation_date": "20231115",
      "center_classification_date": "20240224",
      "report_date": "20240306",
      "code_info": "a) REF DYND41470, UDI/DI 40080196033608(case), 10080196033607(unit), Lot Numbers:  2022042690, 2022070690, 2022090790, 2022102590, 2023051790;   b) REF DYND41471, UDI/DI 40080196033622(case), 10080196033621(unit), Lot Numbers:  2022070190, 2022072890, 2022101090, 2022121390, 2022121990, 2023022890, 2023051890;   c) REF DYND40442, UDI/DI 40080196032618(case), 10080196032617(unit), Lot Numbers: 2022040590, 2022051890, 2022072290, 2022090690, 2022100790, 2022093090, 2022101190, 2022122890, 2023051290, 2023060590, 2023080290, 2023092690;   d) REF DYND41472, UDI/DI 40080196996538(case), 10080196996537(unit), Lot Numbers: 2022042590, 2022062390, 2022070590, 2022072590, 2022080890, 2022082590, 2023010690, 2023022790, 2023030890, 2023041090, 2023041990, 2023070590;    e) REF DYND41474, UDI/DI 40080196033653(case), 10080196033652(unit), Lot Numbers: 2022082390, 2022101090, 2022121290, 2022122090, 2023030390, 2023070590, 2023092590;    f) REF DYND41476, UDI/DI 40080196033660(case), 10080196033669(unit), Lot Numbers:  2022062290, 2022072890, 2022102490, 2022122090, 2023030190, 2023051990;   g) REF DYND41478, UDI/DI 40080196033677(case), 10080196033676(unit), Lot Numbers:  2022042890, 2022070690, 2022082390, 2022100690, 2022121290, 2023010490, 2023041490, 2023080890, 2023092590;   h) REF DYND41442, UDI/DI 40080196033578(case), 10080196033577(unit), Lot Numbers:   2022031590, 2022032290, 2022042790, 2022060290, 2022053190, 2022052790, 2022060690, 2022072690, 2022072790, 2022082490, 2022102490, 2023012490, 2023030390, 2023032390, 2023032490, 2023041790, 2023060190, 2023060290, 2023070590",
      "more_code_info": ""
    }
  ]
}