Recall Z-2243-2018 ยท EXS Urinometer, Electrical
C.R. Bard, Inc.
CritiCore Automated Urine Output and Temperature Monitor
| Date | Nov 10, 2017 |
| Status | Open, Classified |
| Reason | Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms. |
| Root cause | Other |
| Action | On Nov 10, 2017 Bard Medical sent notification letter to all their consignees informing them of the following: Action required: "Immediately examine your inventory and quarantine product subject to this recall. Please refer to CritiCore MonitorAffected Serial Numbers (Attachment 2) to help you locate the affected product serial number. Do not use or furtherdistribute any affected product. "Please complete and return the accompanying Recall & Effectiveness Check Form (Attachment 1) attached to thisletter regardless of whether you have any of the affected product. Additional instructions for p |
| Distribution | AR, AZ, CA, FL, GA, HI, IN, JP, KS, LA, MD, MN, MO, MS, NC, NJ, OH, OK, TN, TX, VA, WA, WI, and WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.