{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "220087",
      "product_res_number": "Z-2319-2026",
      "event_date_initiated": "2026-04-29",
      "event_date_posted": "2026-06-05",
      "recall_status": "Open, Classified",
      "res_event_number": "98891",
      "product_code": "MPB",
      "k_numbers": [
        "K120674"
      ],
      "product_description": "Mahurkar Elite PASS Trays;\nDescription (Product Number/CFN):\n12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424);  for acute hemodialysis, aphaeresis, and infusion.",
      "code_info": "1.\tProduct Number (CFN): 8888221413; UDI-DI: 10884521788541; Lot numbers: 241620022, 252020038;\n2.\tProduct Number (CFN): 8888222416; UDI-DI: 10884521788602; Lot numbers: 241690023, 241830147;\n3.\tProduct Number (CFN): 8888221416; UDI-DI: 10884521788558; Lot numbers: 251250041, 251740190, 252020039, 252090031, 253350256;\n4.\tProduct Number (CFN): 8888222420; UDI-DI: 10884521788619; Lot numbers: 251740186, 252510026, 253280016;\n5.\tProduct Number (CFN): 8888221420; UDI-DI: 10884521788565; Lot numbers: 241620407, 251950032;\n6.\tProduct Number (CFN): 8888222424; UDI-DI: 10884521788626; Lot number: 243040007;\n7.\tProduct Number (CFN): 8888221424; UDI-DI: 10884521788572; Lot numbers: 241200034, 251250039, 252020037;\n8.\tProduct Number (CFN): 8888221430; UDI-DI: 10884521788589; Lot number: 251250042;\n9.\tProduct Number (CFN): 8888233413; UDI-DI: 10884521788718; Lot number: 250310009;\n10.\tProduct Number (CFN): 8888233416; UDI-DI: 10884521788725; Lot numbers: 250350008, 250690152, 250690153, 250870012, 251010012, 251010013, 251320332, 251320333, 251390368, 251390369, 252580023;\n11.\tProduct Number (CFN): 8888233420; UDI-DI: 10884521788732; Lot numbers: 250870013, 250970052, 251320330, 251320331;\n12.\tProduct Number (CFN): 8888231420; UDI-DI: 10884521788688; Lot numbers: 241690216, 252020046, 252230023, 252580025;\n13.\tProduct Number (CFN): 8888233424; UDI-DI: 10884521788749; Lot numbers: 251740197, 252300054;\n14.\tProduct Number (CFN): 8888231424; UDI-DI: 10884521788695; Lot numbers: 251460351, 251740196, 252020045, 252230022, 252580024;\n15.\tProduct Number (CFN): 8888231430; UDI-DI: 10884521788701; Lot number: 252730009;\n16.\tProduct Number (CFN): 8888231413; UDI-DI: 10884521788664; Lot number: 250310010;\n17.\tProduct Number (CFN): 8888231416; UDI-DI: 10884521788671; Lot numbers: 252230021, 252510030, 252650294, 253140280;\n18.\tProduct Number (CFN): 8888213416; UDI-DI: 10884521788527; Lot number: 252300325;\n19.\tProduct Number (CFN): 8888211416; UDI-DI: 10884521788435; Lot numbers: 241060237, 250830187, 250900067, 251250037, 251430012, 252870014;\n20.\tProduct Number (CFN): 8888213420; UDI-DI: 10884521788534; Lot number: 252300051;\n21.\tProduct Number (CFN): 8888211420; UDI-DI: 10884521788442; Lot numbers: 241480021, 242390056, 250070005, 250310011, 250310012, 250760180, 250900066, 251250035, 251950034;\n22.\tProduct Number (CFN): 8888212413; UDI-DI: 10884521788473; Lot number: 242950260;\n23.\tProduct Number (CFN): 8888211413; UDI-DI: 10884521788428; Lot number: 252510028;\n24.\tProduct Number (CFN): 8888212416; UDI-DI: 10884521788480; Lot numbers: 243160028, 250760159, 251250036, 251320325;\n25.\tProduct Number (CFN): 8888212420; UDI-DI: 10884521788497; Lot numbers: 241350005, 250310006, 251740192, 252160037;\n26.\tProduct Number (CFN): 8888211424; UDI-DI: 10884521788459; Lot numbers: 250830185, 250830186, 250900298, 250900299, 251740179, 251950033;",
      "firm_fei_number": "3030574705",
      "recalling_firm": "Mozarc Medical US LLC",
      "address_1": "15 Hampshire St",
      "city": "Mansfield",
      "state": "MA",
      "postal_code": "02048-1113",
      "reason_for_recall": "The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On April 29, 2026 URGENT: MEDICAL DEVICE FIELD NOTICE letters were sent to customers. \nActions to be taken:\n1. If the Clinician notes that the Tegaderm dressing is not in the tray before or during Mahurkar\" Elite PASS Tray use, an alternate sterile catheter dressing may be used as is customary in hospital settings where sterile dressings are routinely available as the standard clinical practice for dialysis catheters.\n2. Share this notice with those who need to be aware within your organization or to any organization including, but not limited to, surgeons, interventionalists, or other staff.\n3. Please maintain a copy of this notice in your records.",
      "product_quantity": "25627",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
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          "K952660",
          "K022221",
          "K974236",
          "K192807",
          "K923691",
          "K010778",
          "K893188",
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          "K980438",
          "K965178",
          "K896252",
          "K250836",
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          "K993933",
          "K040301",
          "K030268",
          "K991431",
          "K983511",
          "K122091",
          "K153190"
        ],
        "device_name": "Catheter, Hemodialysis, Non-Implanted",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5540",
        "device_class": "2",
        "registration_number": [
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