Recall Z-0565-2018— C.R. Bard, Inc.
Class II · Terminated
Class II FDA medical device recall by C.R. Bard, Inc., initiated 2017-11-10, terminated 2021-09-22. FDA's recall record names no specific 510(k) clearance for this event. Product: BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.. Reason: BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors..
- Recalling firm
- C.R. Bard, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-10
- Terminated
- 2021-09-22
- Firm location
- Covington, GA, United States
Product description
BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
Reason for recall
BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.
Data sourced from openFDA. This site is unofficial and independent of the FDA.