—#158971

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.

FDA product code: EXS — Urinometer, Electrical
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Catalog/PC #BK10001M

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

Distribution pattern: US Distribution to the state of: FL

Timeline

Recall initiated: 2017-09-29
Posted by FDA: 2018-01-29
Terminated: 2021-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #158971. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.