{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Golden",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86047",
      "recalling_firm": "CME America, LLC",
      "address_1": "14998 W 6th Ave Ste 830",
      "address_2": "N/A",
      "postal_code": "80401-5025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, AK, CA, CO, CT, FL, ID, IL, KS, LA, MA, MI, MO, MT, NC, NE, NV, Oh, OK, OR, PA, TN, TX, WA, and WI. The country of Canada.",
      "recall_number": "Z-0529-2021",
      "product_description": "CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).",
      "product_quantity": "Total pumps = 4,182 (all models)",
      "reason_for_recall": "Multiple reasons:  1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated.  2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.",
      "recall_initiation_date": "20200730",
      "center_classification_date": "20201203",
      "termination_date": "20220308",
      "report_date": "20201209",
      "code_info": "Model Ameritus 1st Enteral Pump - Part Number(s)  AEG-1PUMP  Serial Number:  58791  58770  58769  58768  58760  26417  26480  26481  26482  26483  26466  26467  26468  26469  26470  26471  26472  26473  26474  26475  26476  26477  26453  26454  26457  26448  26452  26449  26458  26455  26451  26459  26450  26445  26446  26440  26441  26427  26419  26420  26421  26422  26423  26424  26425  26426  26411  26413  26414  26416  26283  26284  26285  26286  26287  26288  26289  26290  26291  26292  26293  26281  26282  26252  26255  26254  26257  26250  26251  26256  26253  26249  26248  26267  26242  26243  26244  26245  26246  26247  26212  26215  26216  26217  26218  26219  26220  26221  26222  26223  26224  26225  26226  26227  26228  26229  26230  26231  26232  26233  26234  26235  26236  26237  26238  26239  26240  26162  26165  26166  26167  26169  26170  26172  26175  26176  26177  26180  26181  26182  26183  26184  26186  26163  26164  26168  26171  26173  26174  26178  26179  26185  26095  26100  26098  26062  26102  26109  26101  26069  26067  26020  26018  26019  26064  26093  26085  26099  26096  26097  26094  26090  26089  26092  26086  26111  26106  26060  26066  26063  26059  26065  26123  26119  26076  26083  26121  26080  26079  26078  26091  26105  26104  26103  26108  26112  26122  26126  26118  26082  26127  26072  26113  26107  26114  26110  26071  26081  26117  26075  26116  26073  26115  26074  26070  26120  26125  26026  26032  26029  26030  26027  26021  58811  58813  58814  58815  58816  58817  58818  58819  58821  58822  58823  58826  58827  58830  58927  58928  58929  58930  58931  58932  69790  69791  69792  69793  69794  69795  69796  69797  69798  69800  69802  69803  69805  69806  69807  69808  69809  69810  69811  69812  69813  69814  69874  69875  69876  69878  69879  69881  69882  A100156  A100157  A100158  S69877  S69880  S69883  S70112  S70122  S70123  S70133  S70135  S70137  S70156  S70171  S70179  S70180  S70197  S70199  S70200  S70201    UDI Code:  B101AEG1PUMP0",
      "more_code_info": ""
    }
  ]
}