Recall Z-1293-2022 ยท EXS Urinometer, Electrical
C.R. Bard Inc
Sensica Urine Output System
| Date | May 19, 2022 |
| Status | Open, Classified |
| Reason | Complaints relating to urine output measurement accuracy. |
| Root cause | Under Investigation by firm |
| Action | The firm issued a recall notification via email and Fed Ex on 05/19/2022. The letter instructs the consignee to immediately discontinue use of the system, quarantine and store to prevent usage, share the notice with users of the product, and return the response form. |
| Quantity | 457 units |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.