FDAClass IIJune 27, 2018

CritiCore Automated Urine Output and Temperature recall

CritiCore Automated Urine Output and Temperature Monitor

Why was CritiCore Automated Urine Output and Temperature recalled?

Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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,

Product
CritiCore Automated Urine Output and Temperature Monitor
Recalling firm
C.R. Bard, Inc.
Quantity
N/A
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
Recall date
June 27, 2018
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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