C.R. Bard, Inc.: CritiCore Automated Urine Output and Temperature Monitor

Recall number

Z-2243-2018

Recalling firm

C.R. Bard, Inc.

Product

CritiCore Automated Urine Output and Temperature Monitor

Status

Open, Classified

Initiated

2017-11-10

Posted

not on file

Terminated

not on file

Reason

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

Root cause

Other

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.

Quantity

not on file

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

Lot, serial or model codes

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,

510(k) numbers

not on file

PMA numbers

not on file

Product code

EXS

Firm FEI

1018233

Firm city

Covington

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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