Events

Rappel de Device Recall CritiCore Automated Urine Output and Temperature Monitor

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par C.R. Bard, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    80085
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2243-2018
  • Date de mise en oeuvre de l'événement
    2017-11-10
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164531
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Urinometer, electrical - Product Code EXS
  • Cause
    Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
  • Action
    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

Device Recall CritiCore Automated Urine Output and Temperature Monitor
  • Modèle / numéro de série
    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,
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    CritiCore Automated Urine Output and Temperature Monitor
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Adresse du fabricant
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA