Z-0488-2018Class II

BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output...

Name: Z-0488-2018 BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output...
Creator: C.R. Bard, Inc.
Published: 2017-09-29
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2017-09-29 / Terminated / root cause: design

FDA source

C.R. Bard, Inc. began a recall of BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor... on 2017-09-29. FDA classified it as Class II and gives the reason as "The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0488-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-29
Posted: 2018-01-29
Terminated: 2021-07-07
Recalling firm: C.R. Bard Inc
Product: BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
Product code: EXS Urinometer, Electrical
Reason for recall: The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Bard Medical Division, sent an "URGENT: MEDICAL DEVICE PRODUCT RECALL" letter dated September 29, 2017 to their consignee. The letter described the product, problem and actions to be taken. The consignee was instructed to immediately examine your inventory and quarantine product; do not use or further distribute any affected product; complete and return the Recall & Effectiveness Check Form by fax to 1-770-784-6460 or email a scanned copy to [email protected], Attn: Recall Coordinator, even if you do not have any affected product and return the product. 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 #). If you have any questions, contact the Senior Director, Quality Systems & Field Assurance at 770-784-6913 or email: [email protected] or BMD Customer Service at 1-800-526-4455.
Quantity in commerce: 2 units
Distribution: US Distribution to the state of: FL
Product codes and lots: Catalog/PC #BK10001M

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0488-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0488-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29

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)