Device Recall CritiCore Automated Urine Output and Temperature Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 C.R. Bard, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    80085
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2243-2018
  • 사례 시작날짜
    2017-11-10
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Urinometer, electrical - Product Code EXS
  • 원인
    Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
  • 조치
    On Nov 10, 2017 Bard Medical sent notification letter to all their consignees informing them of the following: Action required: "Immediately examine your inventory and quarantine product subject to this recall. Please refer to CritiCore MonitorAffected Serial Numbers (Attachment 2) to help you locate the affected product serial number. Do not use or furtherdistribute any affected product. "Please complete and return the accompanying Recall & Effectiveness Check Form (Attachment 1) attached to thisletter regardless of whether you have any of the affected product. Additional instructions for product return arecontained on the form. "If you have further distributed any units with the referenced serial numbers, please identify your customers and notifythem at once of this product recall: Your notification should include a copy of this letter and the accompanying enclosures. Please complete this form by 11/24/2017 and fax to 1-770-784-6469 or email a scanned copy to BMD.FieldAction@crbard.com . If you have affected product, please contact the BMD Customer Service via phone at 1-800-526-4455 option 5 and again option 5 or email BMD.FieldAction@crbard.com to obtain a Return Goods Authorization number (RGA #). Fax this form to 1-770-784-6469 or email a scanned copy to BMD.FieldAction@crbard.com. Attn: Recall Coordinator This recall should be carried out to the user level.

Device

  • 모델명 / 제조번호(시리얼번호)
    DYZIAA003, DYAPAA017, DYARAA002, DYARAA047, DYBPAA012, DYBRAA022, DYBSAA022, DYBSAA067, DYZIAA004, DYAPAA018, DYARAA003, DYARAA048, DYBPAA013, DYBRAA023, DYBSAA023, DYBSAA068, DYZIAA005, DYAPAA019, DYARAA004, DYARAA049, DYBPAA014, DYBRAA024, DYBSAA024, DYBSAA069, DYZIAA006, DYAPAA020, DYARAA005, DYARAA050, DYBPAA015, DYBRAA025, DYBSAA025, DYBSAA070, DYZIAA007, DYAQAA001, DYARAA006, DYARAA051, DYBPAA016, DYBRAA026, DYBSAA026, DYBSAA071,  DYZIAA008, DYAQAA002, DYARAA007, DYARAA052, DYBPAA017, DYBRAA027, DYBSAA027, DYBSAA072, DYZIAA009, DYAQAA003, DYARAA008, DYARAA053, DYBPAA018, DYBRAA028, DYBSAA028, DYBSAA073, DYZIAA010, DYAQAA004, DYARAA009, DYARAA054, DYBPAA019, DYBRAA029, DYBSAA029, DYBSAA074, DYZJAA001, DYAQAA005, DYARAA010, DYARAA055, DYBPAA020, DYBRAA030, DYBSAA030, DYBSAA075, DYZKAA001, DYAQAA006, DYARAA011, DYARAA056, DYBQAA001, DYBRAA031, DYBSAA031, DYBSAA076, DYZKAA002, DYAQAA007, DYARAA012, DYARAA057, DYBQAA002,  DYBRAA032, DYBSAA032, DYBSAA077, DYZKAA003, DYAQAA008, DYARAA013, DYARAA058, DYBQAA003, DYBRAA033, DYBSAA033, DYBSAA078, DYZKAA004, DYAQAA009, DYARAA014, DYARAA059, DYBQAA004, DYBRAA034, DYBSAA034, DYBSAA079, DYZKAA005, DYAQAA010, DYARAA015, DYARAA060, DYBQAA005, DYBRAA035, DYBSAA035, DYBSAA080, DYZKAA006, DYAQAA011, DYARAA016, DYASAA001, DYBQAA006, DYBRAA036, DYBSAA036, DYBSAA081, DYZKAA007, DYAQAA012, DYARAA017, DYASAA002, DYBQAA007, DYBRAA037, DYBSAA037, DYBSAA082, DYZKAA008, DYAQAA013, DYARAA018, DYASAA003, DYBQAA008, DYBRAA038, DYBSAA038, DYBSAA083, DYZKAA009, DYAQAA014, DYARAA019, DYASAA004, DYBQAA009, DYBRAA039, DYBSAA039, DYBSAA084, DYZKAA010, DYAQAA015, DYARAA020, DYASAA005, DYBQAA010, DYBRAA040, DYBSAA040, DYBSAA085, DYZKAA011, DYAQAA016, DYARAA021, DYASAA006, DYBQAA011, DYBRAA041, DYBSAA041, DYBSAA086, DYZKAA012, DYAQAA017, DYARAA022, DYASAA007, DYBQAA012, DYBRAA042, DYBSAA042, DYBSAA087, DYZKAA013, DYAQAA018, DYARAA023, DYASAA008, DYBQAA013, DYBRAA043, DYBSAA043, DYBSAA088, DYZKAA014, DYAQAA019, DYARAA024, DYASAA009, DYBQAA014, DYBRAA044, DYBSAA044, DYBSAA089, DYZKAA015, DYAQAA020, DYARAA025, DYASAA010, DYBQAA015, DYBRAA045, DYBSAA045, DYBSAA090, DYZKAA016, DYAQAA021, DYARAA026, DYASAA011, DYBRAA001, DYBSAA001, DYBSAA046, DYBSAA091, DYZKAA017, DYAQAA022, DYARAA027, DYASAA012, DYBRAA002, DYBSAA002, DYBSAA047, DYBSAA092, DYZKAA018, DYAQAA023, DYARAA028, DYASAA013, DYBRAA003, DYBSAA003, DYBSAA048, DYBSAA093, DYZKAA019, DYAQAA024, DYARAA029, DYASAA014, DYBRAA004, DYBSAA004, DYBSAA049, DYBSAA094, DYZKAA020, DYAQAA025, DYARAA030, DYASAA015, DYBRAA005, DYBSAA005, DYBSAA050, DYBSAA095, DYAPAA001, DYAQAA026, DYARAA031, DYASAA016, DYBRAA006, DYBSAA006, DYBSAA051, DYBSAA096, DYAPAA002, DYAQAA027, DYARAA032, DYASAA017, DYBRAA007, DYBSAA007, DYBSAA052, DYBSAA097, DYAPAA003, DYAQAA028, DYARAA033, DYASAA018, DYBRAA008, DYBSAA008, DYBSAA053, DYBSAA098, DYAPAA004, DYAQAA029, DYARAA034, DYASAA019, DYBRAA009, DYBSAA009, DYBSAA054, DYBSAA099, DYAPAA005, DYAQAA030, DYARAA035, DYASAA020, DYBRAA010, DYBSAA010, DYBSAA055, DYBSAA100, DYAPAA006, DYAQAA031, DYARAA036, DYBPAA001, DYBRAA011, DYBSAA011, DYBSAA056, DYBTAA001, DYAPAA007, DYAQAA032, DYARAA037, DYBPAA002, DYBRAA012, DYBSAA012, DYBSAA057, DYBTAA002, DYAPAA008, DYAQAA033, DYARAA038, DYBPAA003, DYBRAA013, DYBSAA013, DYBSAA058, DYBTAA003, DYAPAA009, DYAQAA034, DYARAA039, DYBPAA004, DYBRAA014, DYBSAA014, DYBSAA059, DYBTAA004, DYAPAA010, DYAQAA035, DYARAA040, DYBPAA005, DYBRAA015, DYBSAA015, DYBSAA060, DYBTAA005, DYAPAA011, DYAQAA036, DYARAA041, DYBPAA006, DYBRAA016, DYBSAA016, DYBSAA061, DYBTAA006, DYAPAA012, DYAQAA037, DYARAA042,DYBPAA007, DYBRAA017, DYBSAA017, DYBSAA062, DYBTAA007, DYAPAA013, DYAQAA038, DYARAA043, DYBPAA008, DYBRAA018, DYBSAA018, DYBSAA063, DYBTAA008, DYAPAA014, DYAQAA039, DYARAA044, DYBPAA009, DYBRAA019, DYBSAA019, DYBSAA064, DYBTAA009, DYBTAA010, DYBTAA027, DYBTAA044, DYBUAA001, DYBUAA018, DYBUAA035, DYBUAA052, DYBUAA069, DYBTAA011, DYBTAA028, DYBTAA045, DYBUAA002, DYBUAA019, DYBUAA036, DYBUAA053, DYBUAA070, DYBTAA012, DYBTAA029, DYBTAA046, DYBUAA003, DYBUAA020, DYBUAA037, DYBUAA054, DYBUAA071, DYBTAA013, DYBTAA030, DYBTAA047, DYBUAA004, DYBUAA021, DYBUAA038, DYBUAA055, DYBUAA072, DYBTAA014, DYBTAA031, DYBTAA048, DYBUAA005, DYBUAA022, DYBUAA039, DYBUAA056, DYBUAA073, DYBTAA015, DYBTAA032, DYBTAA049, DYBUAA006, DYBUAA023, DYBUAA040, DYBUAA057, DYBUAA074, DYBTAA016, DYBTAA033, DYBTAA050, DYBUAA007, DYBUAA024, DYBUAA041, DYBUAA058, DYBUAA075, DYBTAA017, DYBTAA034, DYBTAA051, DYBUAA008, DYBUAA025, DYBUAA042, DYBUAA059, DYBUAA076, DYBTAA018, DYBTAA035, DYBTAA052, DYBUAA009, DYBUAA026, DYBUAA043, DYBUAA060, DYBUAA077, DYBTAA019, DYBTAA036, DYBTAA053, DYBUAA010, DYBUAA027, DYBUAA044, DYBUAA061, DYBUAA078, DYBTAA020, DYBTAA037, DYBTAA054, DYBUAA011, DYBUAA028, DYBUAA045, DYBUAA062, DYBUAA079, DYBTAA021, DYBTAA038, DYBTAA055, DYBUAA012, DYBUAA029, DYBUAA046, DYBUAA063, DYBUAA080, DYBTAA022, DYBTAA039, DYBTAA056, DYBUAA013, DYBUAA030, DYBUAA047, DYBUAA064, DYBTAA023, DYBTAA040, DYBTAA057, DYBUAA014, DYBUAA031, DYBUAA048, DYBUAA065, DYBTAA024, DYBTAA041, DYBTAA058, DYBUAA015, DYBUAA032, DYBUAA049, DYBUAA066, DYBTAA025, DYBTAA042, DYBTAA059, DYBUAA016, DYBUAA033, DYBUAA050, DYBUAA067, DYBTAA026, DYBTAA043, DYBTAA060, DYBUAA017, DYBUAA034, DYBUAA051, and  DYBUAA068,
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AR, AZ, CA, FL, GA, HI, IN, JP, KS, LA, MD, MN, MO, MS, NC, NJ, OH, OK, TN, TX, VA, WA, WI, and WY
  • 제품 설명
    CritiCore Automated Urine Output and Temperature Monitor
  • Manufacturer

Manufacturer