{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "217453",
      "product_res_number": "Z-0993-2026",
      "event_date_initiated": "2025-11-26",
      "event_date_posted": "2025-12-23",
      "recall_status": "Open, Classified",
      "res_event_number": "98027",
      "product_code": "DYB",
      "k_numbers": [
        "K142829"
      ],
      "product_description": "Flexor Check-Flo Introducers and Sets, Reference Part Numbers:  \n1) KCFW-9.0-18/38-45-RB-ANL0-HC; \n2) KCFW-9.0-18/38-45-RB-ANL1-HC; \n3) KCFW-10.0-35-45-RB-HFANL0-HC; \n4) KCFW-10.0-35-45-RB-HFANL1-HC; \n5) KCFW-12.0-35-45-RB-HFANL0-HC; \n6) KCFW-12.0-35-45-RB-HFANL1-HC; \n7) KCFW-9.0-35-38.5-RB-RTPS-100; \n8) KCFW-10.0-35-RB-RTPS-100; \n9) KCFW-9.0-38-55-RB-RAABE; \n10) KCFW-9.0-38-70-RB-RAABE; \n11) KCFW-9.0-38-80-RB; \n12) KCFW-10.0-38-30-RB; \n13) KCFW-10.0-38-40-RB; \n14) KCFW-10.0-38-80-RB; \n15) KCFW-10.0-38-RB; \n16) KCFW-12.0-38-40-RB; \n17) KCFW-12.0-38-80-RB; \nFlexor Introducers and Guiding Sheaths are designed to perform as a guiding sheath and/or introducer sheath. Flexor Introducers and Guiding Sheaths incorporate a Flexor shaft with a hemostasis valve and are provided with one or more dilators. These devices are available in various sizes, lengths and configurations. Configurations include differences in shaft construction, such as varying shaft stiffness and distal tip material and shape, dilator material, hydrophilic coating and/or distal radiopaque markers.",
      "code_info": "Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL0-HC:  Order Number G49101, UDI (01)00827002491014(17)280708(10)16683401, Lot Number 16683401; \nReference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC:  Order Number G49102, UDI (01)00827002491021(17)280709(10)16685978, Lot Number 16685978; \nReference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC:  Order Number G49102, UDI (01)00827002491021(17)280804(10)NS16724225, Lot Number NS16724225; \nReference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC:  Order Number G49102, UDI (01)00827002491021(17)280808(10)NS16733075, Lot Number NS16733075; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC:  Order Number G56278, UDI (01)00827002562783(17)280619(10)16652188, Lot Number 16652188; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC:  Order Number G56278, UDI (01)00827002562783(17)280620(10)16653824, Lot Number 16653824; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC:  Order Number G56278, UDI (01)00827002562783(17)280626(10)16662713, Lot Number 16662713; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC:  Order Number G56278, UDI (01)00827002562783(17)280626(10)16662715, Lot Number 16662715; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC:  Order Number G56278, UDI (01)00827002562783(17)280701(10)16675034, Lot Number 16675034; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC:  Order Number G56278, UDI (01)00827002562783(17)280716(10)16696277, Lot Number 16696277; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC:  Order Number G56278, UDI (01)00827002562783(17)280721(10)16703198, Lot Number 16703198; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC:  Order Number G56278, UDI (01)00827002562783(17)280722(10)16704975, Lot Number 16704975; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC:  Order Number G56278, UDI (01)00827002562783(17)280724(10)16709796, Lot Number 16709796; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC:  Order Number G56278, UDI (01)00827002562783(17)280731(10)16720389, Lot Number 16720389; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL0-HC:  Order Number G56278, UDI (01)00827002562783(17)280617(10)16647121, Lot Number 16647121; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL1-HC:  Order Number G47700, UDI (01)00827002477001(17)280723(10)16707723, Lot Number 16707723; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL1-HC:  Order Number G47700, UDI (01)00827002477001(17)280806(10)16727474, Lot Number 16727474; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL1-HC:  Order Number G47700, UDI (01)00827002477001(17)280604(10)16629368, Lot Number 16629368; \nReference Part Number (RPN)KCFW-10.0-35-45-RB-HFANL1-HC:  Order Number G47700, UDI (01)00827002477001(17)280627(10)16664784, Lot Number 16664784; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL0-HC:  Order Number G56279, UDI (01)00827002562790(17)280714(10)NS16692276, Lot Number NS16692276; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL0-HC:  Order Number G56279, UDI (01)00827002562790(17)280610(10)16637317, Lot Number 16637317; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL0-HC:  Order Number G56279, UDI (01)00827002562790(17)280618(10)16649121, Lot Number 16649121; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL0-HC:  Order Number G56279, UDI (01)00827002562790(17)280729(10)16716240, Lot Number 16716240; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL0-HC:  Order Number G56279, UDI (01)00827002562790(17)280523(10)16614648, Lot Number 16614648; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL0-HC:  Order Number G56279, UDI (01)00827002562790(17)280611(10)16638978, Lot Number 16638978; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280717(10)16699013, Lot Number 16699013; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280527(10)16616270, Lot Number 16616270; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280609(10)16635801, Lot Number 16635801; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280620(10)16653825, Lot Number 16653825; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280627(10)16664786, Lot Number 16664786; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280702(10)16677072, Lot Number 16677072; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280728(10)16712983, Lot Number 16712983; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280728(10)16712985, Lot Number 16712985; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280731(10)16720393, Lot Number 16720393; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280813(10)16739603, Lot Number 16739603; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280520(10)16607958, Lot Number 16607958; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280605(10)16632678, Lot Number 16632678; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280702(10)16677073, Lot Number 16677073; \nReference Part Number (RPN)KCFW-12.0-35-45-RB-HFANL1-HC:  Order Number G47701, UDI (01)00827002477018(17)280711(10)16690408, Lot Number 16690408; \nReference Part Number (RPN)KCFW-9.0-35-38.5-RB-RTPS-100:  Order Number G13160, UDI (01)00827002131606(17)280721(10)NS16703184, Lot Number NS16703184; \nReference Part Number (RPN)KCFW-9.0-35-38.5-RB-RTPS-101:  Order Number G13160, UDI (01)00827002131606(17)280723(10)16707656, Lot Number 16707656; \nReference Part Number (RPN)KCFW-9.0-35-38.5-RB-RTPS-102:  Order Number G13160, UDI (01)00827002131606(17)280609(10)16635746, Lot Number 16635746; \nReference Part Number (RPN)KCFW-10.0-35-RB-RTPS-100:  Order Number G13081, UDI (01)00827002130814(17)280612(10)16641423, Lot Number 16641423; \nReference Part Number (RPN)KCFW-10.0-35-RB-RTPS-100:  Order Number G13081, UDI (01)00827002130814(17)280618(10)16649110, Lot Number 16649110; \nReference Part Number (RPN)KCFW-9.0-38-55-RB-RAABE:  Order Number G36393, UDI (01)00827002363939(17)280520(10)16607912, Lot Number 16607912; \nReference Part Number (RPN)KCFW-9.0-38-70-RB-RAABE:  Order Number G12606, UDI (01)00827002126060(17)280711(10)16690398, Lot Number 16690398; \nReference Part Number (RPN)KCFW-9.0-38-70-RB-RAABE:  Order Number G12606, UDI (01)00827002126060(17)280721(10)16703171, Lot Number 16703171; \nReference Part Number (RPN)KCFW-9.0-38-70-RB-RAABE:  Order Number G12606, UDI (01)00827002126060(17)280529(10)16621284, Lot Number 16621284; \nReference Part Number (RPN)KCFW-9.0-38-70-RB-RAABE:  Order Number G12606, UDI (01)00827002126060(17)280620(10)16653803, Lot Number 16653803; \nReference Part Number (RPN)KCFW-9.0-38-70-RB-RAABE:  Order Number G12606, UDI (01)00827002126060(17)280523(10)16614610, Lot Number 16614610; \nReference Part Number (RPN)KCFW-9.0-38-80-RB:  Order Number G09442, UDI (01)00827002094420(17)280723(10)NS16707657, Lot Number NS16707657; \nReference Part Number (RPN)KCFW-9.0-38-80-RB:  Order Number G09442, UDI (01)00827002094420(17)280515(10)NS16602824, Lot Number NS16602824; \nReference Part Number (RPN)KCFW-9.0-38-80-RB:  Order Number G09442, UDI (01)00827002094420(17)280609(10)NS16635753, Lot Number NS16635753; \nReference Part Number (RPN)KCFW-9.0-38-80-RB:  Order Number G09442, UDI (01)00827002094420(17)280611(10)NS16638955, Lot Number NS16638955; \nReference Part Number (RPN)KCFW-10.0-38-30-RB:  Order Number G13032, UDI (01)00827002130326(17)280729(10)16716200, Lot Number 16716200; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280520(10)16607936, Lot Number 16607936; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280611(10)16638956, Lot Number 16638956; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280610(10)16637278, Lot Number 16637278; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280610(10)16637282, Lot Number 16637282; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280616(10)16644768, Lot Number 16644768; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280617(10)16647072, Lot Number 16647072; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280617(10)16647073, Lot Number 16647073; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280624(10)16657904, Lot Number 16657904; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280624(10)16657905, Lot Number 16657905; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280630(10)16673098, Lot Number 16673098; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280630(10)16673112, Lot Number 16673112; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280630(10)16673113, Lot Number 16673113; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280710(10)16688777, Lot Number 16688777; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280710(10)16688778, Lot Number 16688778; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280711(10)16690378, Lot Number 16690378; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280715(10)16693991, Lot Number 16693991; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280722(10)16704894, Lot Number 16704894; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280722(10)16704906, Lot Number 16704906; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280724(10)16709786, Lot Number 16709786; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280724(10)16709787, Lot Number 16709787; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280729(10)16716212, Lot Number 16716212; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280729(10)16716213, Lot Number 16716213; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280801(10)16721859, Lot Number 16721859; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280801(10)16721860, Lot Number 16721860; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280801(10)16721868, Lot Number 16721868; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280801(10)16721875, Lot Number 16721875; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280801(10)16721876, Lot Number 16721876; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280515(10)16602829, Lot Number 16602829; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280520(10)16607937, Lot Number 16607937; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280523(10)16614632, Lot Number 16614632; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280530(10)16623383, Lot Number 16623383; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280605(10)16632466, Lot Number 16632466; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280610(10)16637284, Lot Number 16637284; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280611(10)16638969, Lot Number 16638969; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280630(10)16673114, Lot Number 16673114; \nReference Part Number (RPN)KCFW-10.0-38-40-RB:  Order Number G32233, UDI (01)00827002322332(17)280613(10)16643080, Lot Number 16643080; \nReference Part Number (RPN)KCFW-10.0-38-80-RB:  Order Number G13033, UDI (01)00827002130333(17)280529(10)16621305, Lot Number 16621305; \nReference Part Number (RPN)KCFW-10.0-38-80-RB:  Order Number G13033, UDI (01)00827002130333(17)280523(10)16614616, Lot Number 16614616; \nReference Part Number (RPN)KCFW-10.0-38-80-RB:  Order Number G13033, UDI (01)00827002130333(17)280610(10)NS16637285, Lot Number NS16637285; \nReference Part Number (RPN)KCFW-10.0-38-80-RB:  Order Number G13033, UDI (01)00827002130333(17)280617(10)NS16647074, Lot Number NS16647074; \nReference Part Number (RPN)KCFW-10.0-38-80-RB:  Order Number G13033, UDI (01)00827002130333(17)280729(10)NS16716215, Lot Number NS16716215; \nReference Part Number (RPN)KCFW-10.0-38-RB:  Order Number G13031, UDI (01)00827002130319(17)280613(10)16643081, Lot Number 16643081; \nReference Part Number (RPN)KCFW-10.0-38-RB:  Order Number G13031, UDI (01)00827002130319(17)280715(10)16693981, Lot Number 16693981; \nReference Part Number (RPN)KCFW-10.0-38-RB:  Order Number G13031, UDI (01)00827002130319(17)280523(10)16614624, Lot Number 16614624; \nReference Part Number (RPN)KCFW-10.0-38-RB:  Order Number G13031, UDI (01)00827002130319(17)280611(10)16638970, Lot Number 16638970; \nReference Part Number (RPN)KCFW-12.0-38-40-RB:  Order Number G32373, UDI (01)00827002323735(17)280605(10)16632469, Lot Number 16632469; \nReference Part Number (RPN)KCFW-12.0-38-40-RB:  Order Number G32373, UDI (01)00827002323735(17)280708(10)16683354, Lot Number 16683354; \nReference Part Number (RPN)KCFW-12.0-38-40-RB:  Order Number G32373, UDI (01)00827002323735(17)280619(10)16652152, Lot Number 16652152; \nReference Part Number (RPN)KCFW-12.0-38-80-RB:  Order Number G49487, UDI (01)00827002494879(17)280806(10)16727445, Lot Number 16727445; \nReference Part Number (RPN)KCFW-12.0-38-80-RB:  Order Number G49487, UDI (01)00827002494879(17)280529(10)16621277, Lot Number 16621277; \nReference Part Number (RPN)KCFW-12.0-38-80-RB:  Order Number G49487, UDI (01)00827002494879(17)280603(10)16627324, Lot Number 16627324; \nReference Part Number (RPN)KCFW-12.0-38-80-RB:  Order Number G49487, UDI (01)00827002494879(17)280529(10)16621278, Lot Number 16621278; \nReference Part Number (RPN)KCFW-12.0-38-80-RB:  Order Number G49487, UDI (01)00827002494879(17)280731(10)16720362, Lot Number 16720362; \nReference Part Number (RPN)KCFW-12.0-38-80-RB:  Order Number G49487, UDI (01)00827002494879(17)280522(10)16613273, Lot Number 16613273; \nReference Part Number (RPN)KCFW-12.0-38-80-RB:  Order Number G49487, UDI (01)00827002494879(17)280523(10)16614607, Lot Number 16614607; \nReference Part Number (RPN)KCFW-12.0-38-80-RB:  Order Number G49487, UDI (01)00827002494879(17)280528(10)16618070, Lot Number 16618070.",
      "firm_fei_number": "1820334",
      "recalling_firm": "Cook Incorporated",
      "address_1": "750 N Daniels Way",
      "city": "Bloomington",
      "state": "IN",
      "postal_code": "47404-9120",
      "additional_info_contact": "Cook Medical Customer Relations Department\n800-457-4500",
      "reason_for_recall": "Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.",
      "root_cause_description": "Process control",
      "action": "Cook Medical issued an URGENT:  MEDICAL DEVICE RECALL notice to its consignees on 11/26/2025 by email and/or letter delivered via a courier.  The notice explained the issue, risk to health, and requested the identification and return of the affected product.  The notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred.  \nFor questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.",
      "product_quantity": "7952 units",
      "distribution_pattern": "Worldwide distribution.",
      "openfda": {
        "k_number": [
          "K081394",
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