{
  "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": "Waltham",
      "address_1": "920 Winter St",
      "reason_for_recall": "The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.",
      "address_2": "",
      "product_quantity": "133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213)",
      "code_info": "Serial numbers: 0K0S151413  1K0S167702-7721  1K0S169224-244  1K0S170300-311  1K0S171475-499  1K0S171807-849  1K0S172042-061  1K0S172179-199  1K0S172200-205  1K0S172263-266  2K0S174112-149  2K0S174228-246  2K0S175602-628  2K0S179477-501  2K0S180512  2K0S180513  2K0S180516-533  2K0S180542  2K0S180543  2K0S180546  2K0S180628  2K0S180629  2K0S181311-332  2K0S181338-340  2K0S181343-347  2K0S181705-719  3K0S182625-659  3K0S183305-324  3K0S183906-920  3K0S183971-980  3K0S184849-912  3K0S185281-284  3K0S185307-311  3K0S185716-745  3K0S185974-989  3K0S185991-998  3K0S186031-045  3K0S186933-962  3K0S186989-7002  4K0S190280  4K0S190306-  4K0S190307  4K0S190309  4K0S190313  4K0S190319  4K0S190509-543  4K0S190829-854  4K0S191122-141  4K0S191229-234  4K0S191511-513  4K0S191569-572  4K0S191578- 588  4K0S192226-245  4K0S192512  4K0S192514-517  4K0S192520  4K0S192522-524  4K0S192526  4K0S192528  4K0S192529  4K0S192533  4K0S192536  4K0S192538  4K0S192540  4K0S192729  4K0S192735  4K0S-J232  4K0S-J943-J944  4K0S-J947-J952  4K0S-L720-L723  4K0S-M703-M708  4K0S-N151- N160  4K0S-N842- N850  4K0S-N913  4K0S-P288- P299  4K0S-P980- P982  4K0S-Q634- Q643  4K0S-Q688- Q697  4K0S-R079- R083  4K0S-R106- R115  4K0S-R134-R138  4K0S-S703- S722  5K0S-159D- 168D  5K0S-180C- 185C  5K0S-305C- 312C  5K0S-320C- 321C  5K0S-322B  5K0S-354D- 363D  5K0S-451B  5K0S-453B-457B  5K0S-459B- 470B  5K0S-866B- 869B  5K0S-877D- 886D  5K0S-T139  5K0S-T880- T899  5K0S-U131  5K0S-V190- V204  5K0S-X981- X983  5K0S-X986- X990  5K0S-Y001- Y010  5K0S-Z650- Z669  6K0S-004Q  6K0S-006M  6K0S-006Q- 014Q  6K0S-007M- 11M  6K0S-008R- 015R  6K0S-016M- 027M  6K0S-017R- 019R  6K0S-027Q- 031Q  6K0S-050M- 053M  6K0S-056N- 063N  6K0S-085L  6K0S-092L  6K0S-191E- 195E  6K0S-216E- 220E  6K0S-317L- 327L  6K0S-318H- 327H  6K0S-331H- 340H  6K0S-431N- 432N  6K0S-435N- 438N  6K0S-466G- 474G  6K0S-467K- 373K  6K0S-469J- 475K  6K0S-476G- 485G  6K0S-477J- 493J  6K0S-477K- 492K  6K0S-501F- 517F  6K0S-532F- 534F  6K0S-610L  6K0S-668L- 673L  6K0S-715R- 718R  6K0S-721R  6K0S-722R  6K0S-725R- 732R  6K0S-745N- 758N  6K0S-770R- 783R  6K0S-787R  6K0S-801K- 803K  6K0S-805K- 822K  6K0S-834N  6K0S-835N  6K0S-844G- 852G  6K0S-938Q- 946Q  6K0S-949Q- 955Q  6K0S-957Q  6K0S-958Q  6K0S-974P- 976P  6K0S-981P  6K0S-982G  6K0S-985P- 987P  6K0S-992P- 998P  7K0S100575- 579  7K0S100615- 618  7K0S100621  7K0S100714  7K0S100716  7K0S100718- 720  7K0S100936- 938  7K0S100940  7K0S101630- 634  7K0S102597- 605  7K0S102656  7K0S102657  7K0S102659- 665  7K0S102982- 986  7K0S103047- 051  7K0S103528- 532  7K0S103595- 599  7K0S103780- 784  7K0S103840- 844  7K0S103895- 899  7K0S104956- 960  7K0S105016  7K0S105020- 023  7K0S105075- 078  7K0S105080  7K0S105990- 994  7K0S106053- 056  7K0S106115  7K0S106374- 378  7K0S106397- 400  7K0S106422  7K0S106456  7K0S106458- 460  7K0S106467  7K0S107627- 631  7K0S107745- 754  7K0S107921- 925  7K0S107994- 999  7K0S108010  7K0S108012  7K0S108015  7K0S108079  7K0S108080  7K0S108255- 258  7K0S108312  7K0S108327- 330  7K0S108372- 376  7K0S108482- 486  7K0S109370- 374  7K0S109397- 401  7K0S109462- 466  7K0S109902- 906  7K0S110118- 121  7K0S110123  7K0S110136- 138  7K0S110141  7K0S110142  7K0S110412  7K0S110416- 418  7K0S110422  7K0S110427  7K0S110428  7K0S110431  7K0S110433  7K0S110434  7K0S110456  7K0S110460- 463  7K0S110484  7K0S110486  7K0S110487  7K0S110489  7K0S110492  7K0S110513  7K0S110514  7K0S110517  7K0S110518  7K0S110521  7K0S110540  7K0S110542  7K0S110543  7K0S110705  7K0S110706  7K0S110710  7K0S110711  7K0S110713  7K0S110715  7K0S110718  7K0S110732  7K0S110733  7K0S110735  7K0S110737  7K0S110739  7K0S110743  7K0S110750  7K0S110769- 771  8K0S117578- 582  8K0S125841  8K0S125842  8K0S125844- 850  8K0S125865  8K0S128089- 120  8K0S131366-399  8K0S131400- 405  8K0S131412- 416  8K0S131420- 447  9K0S134408  9K0S134500",
      "center_classification_date": "20150429",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.",
      "state": "MA",
      "product_description": "2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX    The Fresenius 2008K is indicated for acute and chronic dialysis therapy.",
      "report_date": "20150506",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "recall_number": "Z-1549-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "70574",
      "termination_date": "20210518",
      "more_code_info": "",
      "recall_initiation_date": "20150220",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}