FDANovember 10, 2017device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
c r bard
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 7884262025-11-06
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