{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bethlehem",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97816",
      "recalling_firm": "B Braun Medical Inc",
      "address_1": "824 12th Ave",
      "address_2": "N/A",
      "postal_code": "18018-3524",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.",
      "recall_number": "Z-0670-2026",
      "product_description": "IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.  Labeled as the following with corresponding catalog number:    1. IV ADMIN SET 15 DR W/2 SAFEDAY; Catalog Number: 352636.     2. IV ADMIN SET 15 DR W/2 SAFEDAY 84 IN.; Catalog Number: 352639.     3. IV ADMIN SET 15 DROP W/3 SAFEDAY; Catalog Number: 352640.     4.\tIV ADMIN 15D W/2 SAFEDAY & 0.2 FILTER; Catalog Number: 352643.     5.\tIV ADMIN SET, 105 IN.; Catalog Number: 477003.     6.\tIV ADMIN SET 15D, 4 CARESTIE LAD, 145 IN; Catalog Number: 477006.     7.\tIV ADMIN SET, 121 IN.; Catalog Number: 477008.     8.\tIV ADMIN SET 15D, CARESTIE LAD, 90 IN; Catalog Number: 477012.     9.\tIV ADMIN SET, 2 CARESTIE LAD, 15D, 117IN; Catalog Number: 477019.     10.\tIV ADMIN SET, 15D, 5CARESITE LAD, 136 IN; Catalog Number: 477021.     11.\tIV ADMIN SET 114 IN.; Catalog Number: 477022.     12.\tIV ADMIN SET 5 CARESITE LADS, 126 IN.; Catalog Number: 477023.     13.\tIV SET 15DR 3 SAFEDAY, 106 IN.; Catalog Number: 477053.     14.\tIV ADMIN SET, 15DR, CARESITE LAD, 121 IN; Catalog Number: 490513.     15.\tIV ADMIN SET, 15D, 120 IN.; Catalog Number: 490521.     16.\tIV ADMIN SET 15D 2 CARESITE LADS, 112IN.; Catalog Number: 490527.     17.\tIV ADMIN SET 15 DRP CARESITE SAFEPORT; Catalog Number: 490529.     18.\tIV ADMIN SET, 15D, 139 IN.; Catalog Number: 490535.     19.\tIV ADMIN SET 15D, CARESITE LAD, 122IN.; Catalog Number: 490543.     20.\tIV ADMIN SET 15D 3 CARESITE LADS, 150IN.; Catalog Number: 490546.     21.\tIV ADMIN SET, 125 IN.; Catalog Number: 490547.     22.\tIV ADMIN SET 15D, 5 CARESITE INJ, 150in.; Catalog Number: 490552.     23.\tIV ADMIN SET, 120IN.; Catalog Number: 490553.     24.\tIV ADMIN SETW/ B/C VLV 3 CARESITE 134IN.; Catalog Number: 490554.     25.\tIV ADMIN SET 15DR w/3 B/C VLV, 124 IN.; Catalog Number: 490555.     26.\tIV ADMIN SET  15D w/B/C VLV, 139 IN.; Catalog Number: 490558.     27.\tIV ADMINISTRATION SET, 117 IN.; Catalog Number: 490559.     28.\tIV ADMINISTRATION SET, 108 IN.; Catalog Number: 490560.     29.\tIV ADMINISTRATION SET, 134 IN.; Catalog Number: 490561.     30.\tIV ADMIN SET  15D w/B/C VLV, 140 IN.; Catalog Number: 490562.     31.\tIV ADMIN SET, 111 IN.; Catalog Number: 490563.     32.\tIV ADMIN SET 15D 2 CARESITE LADS, 122 IN; Catalog Number: 490569.     33.\tIV ADMIN SET 15D STOPCOCK, DUAL MANIFOLD; Catalog Number: 490573.     34.\tIV ADMIN SET  15D w/B/C VLV, 110 IN.; Catalog Number: 490574.     35.\tIV ADMIN 15D 5 CARESITE LADS STPCK 120in; Catalog Number: 490575.     36.\tIV ADMIN SET 15D 5 CARESITE LADS, 140 IN; Catalog Number: 490578.     37.\tIV ADMIN SET W/15D, 4 CARESITE LADS; Catalog Number: 490581.     38.\tIV ADMIN 15D CARESITE LADS, STPCK 134 IN; Catalog Number: 490582.     39.\tIV ADMIN SET, 15D, 108 IN.; Catalog Number: 490583.     40.\tIV ADMIN SET, 10 DROP, 130 IN.; Catalog Number: 490588.     41.\tIV ADMIN SET, 132 IN.; Catalog Number: 490589.     42.\tIV ADMIN SET, 15DR, 105 IN.; Catalog Number: 490600.     43.\tIV ADMIN SET,3 CARESITE,3 HF SPCK, 129IN; Catalog Number: 490607.     44.\tIV SET 15DR 3CARESITE 2STOPCOCK, 126IN; Catalog Number: 490608.     45.\tIV ADMIN SET 15D 2 CARESITE LADS, 138 IN; Catalog Number: 490615.     46.\tIV SET 15DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490618.     47.\tIV SET 60DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490619.     48.\tIV ADMIN SET 15 DRPS 4W STOPCOCK W/ C&S; Catalog Number: 490644.     49.\tIV ADMIN SET 15 DRPS ULTRAP. ZERO 90.6IN; Catalog Number: 490657.     50.\tIV ADMIN SET 15 DRPS STOPCOCK MALE 117IN; Catalog Number: 490658.",
      "product_quantity": "20,694,734 units",
      "reason_for_recall": "Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).",
      "recall_initiation_date": "20251029",
      "center_classification_date": "20251126",
      "report_date": "20251203",
      "code_info": "1. Catalog Number: 352636; Primary UDI-DI: 04046955594597; Unit of Dose UDI-DI: 04046955594580; Expiration Date: 36mths from Start Date.   2. Catalog Number: 352639; Primary UDI-DI: 04046955594672; Unit of Dose UDI-DI: 04046955594665; Expiration Date: 36mths from Start Date.   3. Catalog Number: 352640; Primary UDI-DI: 04046955594696; Unit of Dose UDI-DI: 04046955594689; Expiration Date: 36mths from Start Date.   4. Catalog Number: 352643; Primary UDI-DI: 04046955594757; Unit of Dose UDI-DI: 04046955594740; Expiration Date: 36mths from Start Date.   5. Catalog Number: 477003; Primary UDI-DI: 04046955202836; Unit of Dose UDI-DI: 04046955202829; Expiration Date: Earliest Exp of Comp or 36mths.   6. Catalog Number: 477006; Primary UDI-DI: 04046955202751; Unit of Dose UDI-DI: 04046955202744; Expiration Date: Earliest Exp of Comp or 36mths.   7. Catalog Number: 477008; Primary UDI-DI: 04046955202850; Unit of Dose UDI-DI: 04046955202843; Expiration Date: Earliest Exp of Comp or 36mths.   8. Catalog Number: 477012; Primary UDI-DI: 04046955202874; Unit of Dose UDI-DI: 04046955202867; Expiration Date: Earliest Exp of Comp or 36mths.   9. Catalog Number: 477019; Primary UDI-DI: 04046955203147; Unit of Dose UDI-DI: 04046955203130; Expiration Date: Earliest Exp of Comp or 36mths.   10. Catalog Number: 477021; Primary UDI-DI: 04046955269983; Unit of Dose UDI-DI: 04046955269976; Expiration Date: Earliest Exp of Comp or 36mths.   11. Catalog Number: 477022; Primary UDI-DI: 04046955270002; Unit of Dose UDI-DI: 04046955269990; Expiration Date: Earliest Exp of Comp or 36mths.   12. Catalog Number: 477023; Primary UDI-DI: 04046955270026; Unit of Dose UDI-DI: 04046955270019; Expiration Date: Earliest Exp of Comp or 36mths.   13. Catalog Number: 477053; Primary UDI-DI: 04046955672431; Unit of Dose UDI-DI: 04046955672424; Expiration Date: Earliest Exp of Comp or 36mths.   14. Catalog Number: 490513; Primary UDI-DI: 04046955137237; Unit of Dose UDI-DI: 04046955137220; Expiration Date: Earliest Exp of Comp or 36mths.   15. Catalog Number: 490521; Primary UDI-DI: 04046955185252; Unit of Dose UDI-DI: 04046955186563; Expiration Date: Earliest Exp of Comp or 24mths.   16. Catalog Number: 490527; Primary UDI-DI: 04046955203222; Unit of Dose UDI-DI: 04046955203215; Expiration Date: Earliest Exp of Comp or 36mths.   17. Catalog Number: 490529; Primary UDI-DI: 04046955203307; Unit of Dose UDI-DI: 04046955203291; Expiration Date: Earliest Exp of Comp or 24mths.   18. Catalog Number: 490535; Primary UDI-DI: 04046955203406; Unit of Dose UDI-DI: 04046955203390; Expiration Date: Earliest Exp of Comp or 36mths.   19. Catalog Number: 490543; Primary UDI-DI: 04046955270200; Unit of Dose UDI-DI: 04046955270194; Expiration Date: Earliest Exp of Comp or 36mths.   20. Catalog Number: 490546; Primary UDI-DI: 04046955270262; Unit of Dose UDI-DI: 04046955270255; Expiration Date: Earliest Exp of Comp or 36mths.   21. Catalog Number: 490547; Primary UDI-DI: 04046955270286; Unit of Dose UDI-DI: 04046955270279; Expiration Date: Earliest Exp of Comp or 36mths.   22. Catalog Number: 490552; Primary UDI-DI: 04046955275342; Unit of Dose UDI-DI: 04046955275335; Expiration Date: Earliest Exp of Comp or 36mths.   23. Catalog Number: 490553; Primary UDI-DI: 04046955275366; Unit of Dose UDI-DI: 04046955275359; Expiration Date: Earliest Exp of Comp or 36mths.   24. Catalog Number: 490554; Primary UDI-DI: 04046955275380; Unit of Dose UDI-DI: 04046955275373; Expiration Date: Earliest Exp of Comp or 36mths.   25. Catalog Number: 490555; Primary UDI-DI: 04046955275403; Unit of Dose UDI-DI: 04046955275397; Expiration Date: Earliest Exp of Comp or 36mths.   26. Catalog Number: 490558; Primary UDI-DI: 04046955275465; Unit of Dose UDI-DI: 04046955275458; Expiration Date: Earliest Exp of Comp or 36mths.   27. Catalog Number: 490559; Primary UDI-DI: 04046955275489; Unit of Dose UDI-DI: 04046955275472; Expiration Date: Earliest Exp of Comp or 36mths.   28. Catalog Number: 490560; Primary UDI-DI: 04046955275502; Unit of Dose UDI-DI: 04046955275496; Expiration Date: Earliest Exp of Comp or 36mths.   29. Catalog Number: 490561; Primary UDI-DI: 04046955275526; Unit of Dose UDI-DI: 04046955275519; Expiration Date: Earliest Exp of Comp or 36mths.   30. Catalog Number: 490562; Primary UDI-DI: 04046955275540; Unit of Dose UDI-DI: 04046955275533; Expiration Date: Earliest Exp of Comp or 36mths.   31. Catalog Number: 490563; Primary UDI-DI: 04046955275564; Unit of Dose UDI-DI: 04046955275557; Expiration Date: Earliest Exp of Comp or 36mths.   32. Catalog Number: 490569; Primary UDI-DI: 04046955275687; Unit of Dose UDI-DI: 04046955275670; Expiration Date: Earliest Exp of Comp or 36mths.   33. Catalog Number: 490573; Primary UDI-DI: 04046955287451; Unit of Dose UDI-DI: 04046955287444; Expiration Date: Earliest Exp of Comp or 24mths.   34. Catalog Number: 490574; Primary UDI-DI: 04046955287475; Unit of Dose UDI-DI: 04046955287468; Expiration Date: Earliest Exp of Comp or 24mths.   35. Catalog Number: 490575; Primary UDI-DI: 04046955287499; Unit of Dose UDI-DI: 04046955287482; Expiration Date: Earliest Exp of Comp or 36mths.   36. Catalog Number: 490578; Primary UDI-DI: 04046955287550; Unit of Dose UDI-DI: 04046955287543; Expiration Date: Earliest Exp of Comp or 36mths.   37. Catalog Number: 490581; Primary UDI-DI: 04046955287611; Unit of Dose UDI-DI: 04046955287604; Expiration Date: Earliest Exp of Comp or 24mths.   38. Catalog Number: 490582; Primary UDI-DI: 04046955287635; Unit of Dose UDI-DI: 04046955287628; Expiration Date: Earliest Exp of Comp or 36mths.   39. Catalog Number: 490583; Primary UDI-DI: 04046955287659; Unit of Dose UDI-DI: 04046955287642; Expiration Date: Earliest Exp of Comp or 60mths.   40. Catalog Number: 490588; Primary UDI-DI: 04046955287758; Unit of Dose UDI-DI: 04046955287741; Expiration Date: Earliest Exp of Comp or 36mths.   41. Catalog Number: 490589; Primary UDI-DI: 04046955287772; Unit of Dose UDI-DI: 04046955287765; Expiration Date: Earliest Exp of Comp or 36mths.   42. Catalog Number: 490600; Primary UDI-DI: 04046955352777; Unit of Dose UDI-DI: 04046955352760; Expiration Date: Earliest Exp of Comp or 24mths.   43. Catalog Number: 490607; Primary UDI-DI: 04046955352913; Unit of Dose UDI-DI: 04046955352906; Expiration Date: Earliest Exp of Comp or 36mths.   44. Catalog Number: 490608; Primary UDI-DI: 04046955352937; Unit of Dose UDI-DI: 04046955352920; Expiration Date: Earliest Exp of Comp or 36mths.   45. Catalog Number: 490615; Primary UDI-DI: 04046955664672; Unit of Dose UDI-DI: 04046955664665; Expiration Date: Earliest Exp of Comp or 36mths.   46. Catalog Number: 490618; Primary UDI-DI: 04046955664733; Unit of Dose UDI-DI: 04046955664726; Expiration Date: Earliest Exp of Comp or 24mths.   47. Catalog Number: 490619; Primary UDI-DI: 04046955664757; Unit of Dose UDI-DI: 04046955664740; Expiration Date: Earliest Exp of Comp or 24mths.   48. Catalog Number: 490644; Primary UDI-DI: 04046955765003; Unit of Dose UDI-DI: 04046955764990; Expiration Date: Earliest Exp of Comp or 36mths.   49. Catalog Number: 490657; Primary UDI-DI: 04046955836420; Unit of Dose UDI-DI: 04046955836413; Expiration Date: Earliest Exp of Comp or 36mths.   50. Catalog Number: 490658; Primary UDI-DI: 04046955836697; Unit of Dose UDI-DI: 04046955836680; Expiration Date: Earliest Exp of Comp or 36mths.",
      "more_code_info": ""
    }
  ]
}