{
  "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": "217419",
      "product_res_number": "Z-0566-2026",
      "event_date_initiated": "2025-09-26",
      "event_date_posted": "2025-11-19",
      "recall_status": "Open, Classified",
      "res_event_number": "97592",
      "product_code": "GIO",
      "product_description": "Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503",
      "code_info": "Model Number:  07 9503\nGTIN (Inner Pack): 30643351000360 \nUDI-DI:  10643351000366\n\nAll Lots produced from 01FEB2023 to 28FEB2025: \n\n22B4465, 22E4465, 22I4072, 23B4158, 23C4345, 23F4176, 23H4109, 23I4060, 24D4021, 24E4130, 24E4131",
      "firm_fei_number": "3004824601",
      "recalling_firm": "ASP Global, LLC. dba Anatomy Supply Partners, LLC.",
      "address_1": "7800 Third Flag Pkwy",
      "city": "Austell",
      "state": "GA",
      "postal_code": "30168-7657",
      "additional_info_contact": "Tracy Weldon\n+1-470-6490135",
      "reason_for_recall": "Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.",
      "root_cause_description": "Process change control",
      "action": "On 09/26-29/2025, ASP Global emailed an URGENT MEDICAL DEVICE RECALL Letter to customers. ASP Global, LLC, is voluntarily recalling all RAM Scientific SAFE-T-FILL products within remaining expiry. ASP Global was made aware that our contract manufacturer for the RAM Scientific SAFE-T-FILL products was issued an FDA Warning Letter citing significant violations of the Quality System requirements, including inadequate production and process controls, as well as design controls.\n\nCustomers are instructed to:\na)\tDiscontinue use of the recalled products immediately.\nb)\tQuarantine any remaining inventory to prevent further use.\nc)\tIf critical or abnormal test results were obtained using the affected SAFE-T-FILL products, ensure they are verified through repeat or confirmatory testing in accordance with institutional protocols (e.g., venous confirmation of abnormal pediatric screening results).\nd)\tDispose remaining inventory in accordance with your local facility guidelines or notify ASP Global at FieldActions@aspglobal.com for return authorization and disposal.\ne)\tComplete and return the Recall Response Form to confirm receipt and actions to FieldActions@aspglobal.com.\n\nFor questions or assistance - contact FieldActions@aspglobal.com \n(855)-867-2190| Mon Fri, 9:00 AM 5:00 PM ET",
      "product_quantity": "50250",
      "distribution_pattern": "Distribution US nationwide and Canada.",
      "openfda": {
        "k_number": [
          "K850806",
          "K843892",
          "K873647",
          "K972969",
          "K812923",
          "K843362",
          "K894851",
          "K832578",
          "K875061",
          "K812921",
          "K812969",
          "K812922",
          "K881187",
          "K770981",
          "K941291",
          "K843361",
          "K881262",
          "K812970",
          "K885138",
          "K843608",
          "K885324",
          "K884623"
        ],
        "registration_number": [
          "3030733800",
          "3043138885",
          "8043905",
          "3027605742",
          "2432235",
          "3013530901",
          "3027645317",
          "9617475",
          "1933913",
          "9610633",
          "3006808300",
          "3019387954",
          "3010879605",
          "3002807968",
          "3011671735",
          "3012494290",
          "3013846070",
          "3003310007",
          "3006446479",
          "1000555938",
          "3014171027",
          "3017450368",
          "1064584",
          "3005739529",
          "3015341499",
          "2249801",
          "3043088937",
          "1616487",
          "3002637618",
          "3043226252",
          "3016710934",
          "3045058049",
          "3009435759",
          "9610126",
          "3007490412",
          "1618982",
          "3006101929",
          "8010932",
          "2518153",
          "3015525148",
          "3011765035",
          "3007185216",
          "8020040",
          "1119779",
          "3012315023",
          "3003393069",
          "2244900",
          "3021244152",
          "3004008703",
          "3016748351",
          "3016096098",
          "3004102403",
          "3030530726",
          "3006975595",
          "1220649",
          "3009169953",
          "3010834934",
          "3015908492",
          "3004959793",
          "3010194621",
          "3000682787",
          "3002808145",
          "3002805583",
          "2243072"
        ],
        "fei_number": [
          "3030733800",
          "3043138885",
          "3027605742",
          "2432235",
          "3013530901",
          "3027645317",
          "3002806559",
          "3006808300",
          "3019387954",
          "3010879605",
          "3002807968",
          "3011671735",
          "3012494290",
          "3001451226",
          "3013846070",
          "3003310007",
          "3006446479",
          "3002808075",
          "1000555938",
          "3014171027",
          "3017450368",
          "3003063934",
          "3005739529",
          "3015341499",
          "3000974732",
          "3043088937",
          "1616487",
          "3002637618",
          "3043226252",
          "3016710934",
          "3045058049",
          "3009435759",
          "1618982",
          "3007490412",
          "3006101929",
          "2518153",
          "3003238169",
          "3011765035",
          "3007185216",
          "1119779",
          "3003393069",
          "3012315023",
          "3002806693",
          "2244900",
          "3002698769",
          "3021244152",
          "3004008703",
          "3016748351",
          "3016096098",
          "3004102403",
          "3030530726",
          "3003208740",
          "3006975595",
          "1220649",
          "3009169953",
          "3010834934",
          "3015908492",
          "3004959793",
          "3010194621",
          "3000682787",
          "3002808145",
          "3002807393",
          "3002805583",
          "2243072"
        ],
        "device_name": "Tube, Collection, Capillary Blood",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.6150",
        "device_class": "1"
      }
    }
  ]
}