Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Sensica Urine Output System, Catalog Number SCCS1002

FDA Recall Z-0554-2024 · Posted 2023-12-14

Recalling FirmC.R. Bard Inc
Recall StatusOpen, Classified
Product CodeEXS
Date Initiated2023-11-15
Product Quantity148 units

Reason for Recall

BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.

Firm Action

BD (CR Bard) issued an URGENT Medical Device Product Advisory to its consignees on 11/15/2023, via FedEx and email. The notice explained the problem with the device, potential hazard, and requested that the consignee perform Operating System and Sensica Software settings changes per the instructions provided on all devices within your facility s control using the attached directions.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑