Recall Z-2243-2018— C.R. Bard, Inc.
Class II · Ongoing
Class II FDA medical device recall by C.R. Bard, Inc., initiated 2017-11-10. FDA's recall record names no specific 510(k) clearance for this event. Product: CritiCore Automated Urine Output and Temperature Monitor. Reason: Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms..
- Recalling firm
- C.R. Bard, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2017-11-10
- Firm location
- Covington, GA, United States
Product description
CritiCore Automated Urine Output and Temperature Monitor
Reason for recall
Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
Data sourced from openFDA. This site is unofficial and independent of the FDA.