{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210740",
      "product_res_number": "Z-0490-2025",
      "event_date_initiated": "2024-10-15",
      "event_date_posted": "2024-11-19",
      "recall_status": "Open, Classified",
      "res_event_number": "95599",
      "product_code": "OJK",
      "product_description": "a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR;   \nb) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; \nc) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR;   \nd) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.",
      "code_info": "UDI-DI: +H5301ALCON1CPAK10\n\na) Custom Pak # 15340-11: (Lot, Exp) JZ5221212, 2025-02-28; JZ5221710, 2025-02-28; 16PETC, 2025-03-31; 1704TA, 2025-03-31; 16TENC, 2025-07-31; 16UDE9, 2025-07-31; 16WL8F, 2025-07-31; 16X6FE, 2025-07-31.\n\nb) Custom Pak # 6557-59: (Lot, Exp) 2326720H, 2022-02-13; 2333628H, 2022-05-14. Custom Pak # 6557-60: (Lot, Exp) JZ5020496, 2020-10-31; JZ5033702, 2021-03-31; JZ5053771, 2021-12-31; JZ5054044, 2022-01-31; 2343441H, 2022-02-04; 2425727H, 2022-03-13; JZ5070889, 2022-04-30; 2403037H, 2022-05-23; JZ5079439, 2022-05-31; JZ5080320, 2022-05-31; JZ5080898, 2022-05-31; JZ5082125, 2022-05-31; 14VWFU, 2024-12-31; 16DVFW, 2025-02-28; 16R6HM, 2026-01-31; JZ5190740, 2026-02-28.\n\nc) Custom Pak # 9456-59: (Lot, Exp) 2328788H, 2021-09-24; 2326181H, 2021-10-29; 2335667H, 2022-01-22; 2337915H, 2022-01-22; 2330901H, 2022-02-13; 2360751H, 2022-02-13; 2332968H, 2022-05-01. Custom Pak # 9456-60: (Lot, Exp) 2377532H, 2022-02-13; 2433004H, 2022-03-13; 2435844H, 2022-03-31; 2438674H, 2022-03-31; 2443455H, 2022-03-31; 2389892H, 2022-05-23; 2402383H, 2022-05-23; 2409316H, 2022-05-23; 2454167H, 2022-05-31; 2391155H, 2022-06-01; 2394641H, 2022-07-08; 2475011H, 2022-07-31. Custom Pak# 9456-61: (Lot, Exp) 2479674H, 2022-05-31; 2510964H, 2022-05-31; 2517601H, 2022-05-31; 2518895H, 2022-05-31; 2502011H, 2022-09-30; 2503593H, 2022-09-30; 2526469H, 2024-03-31; 2530562H, 2024-05-31; 14C3WK, 2024-06-30; 14FY80, 2024-10-31.\n\nd) Custom Pak # 12216-12: (Lot, Exp) 2326566H, 2021-08-01; 2329339H, 2021-08-01; 2336115H, 2021-10-01; 2388598H, 2022-06-01; 2384136H, 2022-06-17. Custom Pak # 12216-14: (Lot, EXP) 2401018H, 2022-05-23; 2454202H, 2022-05-31; 2482431H, 2022-06-30; 2458169H, 2022-07-31. Custom Pak # 12216-15: (Lot, Exp) JZ5079827, 2022-05-31; JZ5082848, 2022-05-31; JZ5083055, 2022-05-31; JZ5091224, 2022-08-31; JZ5092309, 2022-08-31; JZ5131291, 2023-03-31; JZ5131748, 2023-03-31; JZ5133797, 2023-08-31; JZ5139090, 2023-08-31; JZ5141753, 2023-08-31; JZ5143948, 2023-08-31; JZ5147454, 2023-08-31; JZ5150525, 2023-12-31; JZ5158900, 2023-12-31; 149JHU, 2024-10-31; 15506R, 2024-11-30; 156MR9, 2025-02-28; JZ5187273, 2025-03-31; JZ5187291, 2025-03-31; 15EU0H, 2025-04-30; JZ5187317, 2025-06-30; JZ5194024, 2025-06-30; JZ5195056, 2025-06-30; JZ5204449, 2025-06-30; JZ5211716, 2025-06-30; 15YK89, 2025-07-31; 15KPMM, 2025-08-31; 15KPN5, 2025-08-31; 15TLUR, 2025-09-30; 160631, 2025-10-31; 160DHT, 2025-10-31; 15Y1WT, 2025-12-31; 16D216, 2025-12-31; 16DXHT, 2026-05-31; 16FC7T, 2026-05-31; 16FVYR, 2026-09-30; 16J56N, 2026-09-30; 16JE01, 2026-09-30; 16KFYW, 2026-09-30.",
      "firm_fei_number": "1610287",
      "recalling_firm": "Alcon Research LLC",
      "address_1": "6201 South Fwy",
      "city": "Fort Worth",
      "state": "TX",
      "postal_code": "76134-2099",
      "additional_info_contact": "Kristen Kellerhals\n817-551-4047",
      "reason_for_recall": "Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.",
      "root_cause_description": "Use error",
      "action": "Alcon issued a letter dated October 16, 2024 \"COMMUNICATION OF MEDICAL DEVICE CORRECTION FROM CARDINAL HEALTH\" (ALCON CUSTOM PAK COMPONENT SUPPLIER) regarding Alcon Custom Pak surgical kits which contain Cardinal Health Salem Sump PVC Tubes - Double Lumen Nasogastric (NG) Tube. Alcon is instructing its customers to: \n\n(1) Read the attached Cardinal Health Medical Device Correction notice. Cardinal Health recommends customers review the eIFU and updated product labels. \n(2) Complete the attached Alcon Customer Response Form. \n(3) Return the Alcon Customer Response Form by Fax: 817-302-4337 Email: Market.Actions@Alcon.com at your earliest convenience. Alcon will reconcile the forms and communicate responses to Cardinal Health. \n\nNo product return is requested. Please forward the attached Medical Device Correction notice to professionals within your organization who may be using Alcon Custom Pak surgical kits containing the affected Cardinal Health Salem Sump Tubing.  \n\nContact Alcon Customer Service at 1-800-862-5266 or contact your Alcon Sales Representative with questions or concerns.",
      "product_quantity": "3486 surgical kits",
      "distribution_pattern": "US distribution to states of: Delaware, Illinois, and Oklahoma",
      "openfda": {
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        "device_name": "Eye Tray",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.4790",
        "device_class": "2"
      }
    }
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}