Z-2243-2018Class II

CritiCore Automated Urine Output and Temperature Monitor

Name: Z-2243-2018 CritiCore Automated Urine Output and Temperature Monitor
Creator: C.R. Bard, Inc.
Published: 2017-11-10
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2017-11-10 / Open, Classified

FDA source

C.R. Bard, Inc. began a recall of CritiCore Automated Urine Output and Temperature Monitor on 2017-11-10. FDA classified it as Class II and gives the reason as "Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2243-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-11-10
Posted: 2018-06-15
Recalling firm: C.R. Bard Inc
Product: CritiCore Automated Urine Output and Temperature Monitor
Product code: EXS Urinometer, Electrical
Reason for recall: Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
FDA 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 [email protected] . 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 [email protected] to obtain a Return Goods Authorization number (RGA #). Fax this form to 1-770-784-6469 or email a scanned copy to [email protected]. Attn: Recall Coordinator This recall should be carried out to the user level.
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
Product codes and lots: 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, 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DYBUAA048, DYBUAA065, DYBTAA024, DYBTAA041, DYBTAA058, DYBUAA015, DYBUAA032, DYBUAA049, DYBUAA066, DYBTAA025, DYBTAA042, DYBTAA059, DYBUAA016, DYBUAA033, DYBUAA050, DYBUAA067, DYBTAA026, DYBTAA043, DYBTAA060, DYBUAA017, DYBUAA034, DYBUAA051, and DYBUAA068,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2243-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2243-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-06-27	2018-06-15

Product code EXS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)