Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR see related information
Date Initiated by Firm September 29, 2017
Date Posted January 29, 2018
Recall Status1 Terminated 3 on July 07, 2021
Recall Number Z-0488-2018
Recall Event ID 78231
Product Classification Urinometer, electrical - Product Code EXS
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.
Code Information Catalog/PC #BK10001M
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact
770-784-6120
Manufacturer 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.
FDA Determined
Cause 2		 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 BMD.FieldAction@crbard.com, 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 BMD.FieldAction@crbard.com 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: Brenda.Sheikey@crbard.com or BMD Customer Service at 1-800-526-4455.
Quantity in Commerce 2 units
Distribution US Distribution to the state of: FL
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-