Recall Z-0565-2018 ยท EXS Urinometer, Electrical
C.R. Bard, Inc.
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.
| Date | Nov 10, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | Bard Medical sent an Urgent Medical Device Product Recall letter dated November 10, 2017. Action required: "Immediately examine your inventory and quarantine product subject to this recall. Please refer to CritiCore Monitor Affected Serial Numbers (Attachment 2) to help you locate the affected product serial number. Do not use or further distribute any affected product. "Please complete and return the accompanying Recall & Effectiveness Check Form (Attachment 1) attached to this letter regardless of whether you have any of the affected product. Additional instructions for product return are |
| Quantity | 343 units |
| Distribution | US Distribution and Internationally to Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.