{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Wayne",
      "address_1": "45 Barbour Pond Drive",
      "reason_for_recall": "Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power",
      "address_2": "",
      "product_quantity": "331 units",
      "code_info": "90410803  90410984  90410456  90410609  90410610  90410740  90410737  90410738  90410733  90410865  90411005  90410552  90410572  90410849  90410864  90410867  90410796  90410481  90410319  90410328  90411176  90410988  90410703  90410431  90411186  90411188  90411191  90410800  90410611  90410669  90410517  90410692  90410499  90410500  90410739  90410612  90410714  90410759  90410771  90410430  90410276  90410576  90410482  90410749  90410774  90410859  90410860  90410863  90411088  90411082  90411087  90411091  90411089  90410866  90411144  90410970  90411023  90411033  90411038  90411032  90410974  90410962  90410455  90410448  90410449  90411175  90410524  90411007  90410353  90410433  90410435  90410770  90410785  90410440  90410932  90410968  90410732  90411035  90411028  90410736  90410249  90410410  90410411  90411169  90411157  90410963  90411078  90410237  90410284  90410786  90410772  90410922  90411093  90411192  90411193  90410582  90410516  90410662  90410666  90410664  90410665  90410235  90411189  90411187  90411154  90411179  90411178  90410580  90410596  90410599  90410651  90410646  90410735  90410787  90410839  90410851  90410848  90410852  90410845  90411105  90411143  90411145  90411141  90410530  90410584  90410607  90410575  90410581  90410498  90410756  90410936  90410663  90410909  90410746  90410744  90410450  90410606  90410979  90411004  90411009  90411006  90411010  90410398  90410400  90410399  90410713  90410973  90410351  90410352  90410840  90410242  90410252  90410239  90410426  90410427  90410754  90410503  90410518  90411008  90410573  90410577  90410585  90410668  90410408  90410409  90410653  90410961  90410982  90411174  90410568  90410406  90410640  90410644  90410534  90410537  90410780  90411146  90411181  90411184  90411108  90411107  90411171  90410986  90411003  90410716  90410638  90410717  90411036  90411037  90410847  90410231  90410458  90410779  90410783  90411168  90411170  90410975  90410782  90410846  90410838  90410650  90410608  90410844  90410745  90410980  90410777  90410930  90410278  90410355  90410389  90410989  90410277  90410520  90410964  90410734  90410929  90410927  90410832  90410595  90410532  90410535  90410529  90410969  90411026  90410514  90410519  90410778  90410933  90410928  90411194  90411196  90410453  90411086  90411104  90410842  90410758  90410452  90410985  90410422  90410423  90410670  90410407  90410600  90410850  90411034  90411002  90410256  90410983  90410931  90410752  90410776  90410321  90410413  90410702  90410976  90410523  90410700  90410405  90410454  90410457  90410521  90410551  90410711  90410706  90410742  90410743  90410921  90410925  90411182  90411183  90411185  90411090  90411106  90411155  90411156  90410571  90410446  90410480  90410784  90411092  90410526  90410501  90410533  90410550  90410698  90410841  90410987  90410253  90410234  90411011  90411001  90411012  90411024  90410857  90410858  90411180  90410350  90410981  90410656  90410788  90410795  90411148  90411149  90410232  90410271  90410536  90410924  90410336  90410340  90410459  90410926  90410934  90411190  90410522  90410760  90410251  90410484  90411147  90411197  90411198  90410977  90411025  90411027  90410515  90410843  90410527  90410086  90410747  90410748  90410923  90410978",
      "center_classification_date": "20141113",
      "distribution_pattern": "Worldwide Distribution - US Nationwide",
      "state": "NJ",
      "product_description": "Cardiohelp-I System     Product Usage:  A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).",
      "report_date": "20141119",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Maquet Cardiovascular Us Sales, Llc",
      "recall_number": "Z-0211-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "69557",
      "termination_date": "20160406",
      "more_code_info": "",
      "recall_initiation_date": "20141017",
      "postal_code": "07470",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}