Recall Z-0488-2018 ยท EXS Urinometer, Electrical
C.R. Bard, Inc.
BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
| Date | Jan 29, 2018 (initiated Sep 29, 2017) |
| Status | Terminated |
| Reason | The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions. |
| Root cause | Device Design |
| Action | The firm, Bard Medical Division, sent an "URGENT: MEDICAL DEVICE PRODUCT RECALL" letter dated September 29, 2017 to their consignee. The letter described the product, problem and actions to be taken. The consignee was instructed to immediately examine your inventory and quarantine product; do not use or further distribute any affected product; complete and return the Recall & Effectiveness Check Form by fax to 1-770-784-6460 or email a scanned copy to BMD.FieldAction@crbard.com, Attn: Recall Coordinator, even if you do not have any affected product and return the product. If you have affected |
| Quantity | 2 units |
| Distribution | US Distribution to the state of: FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.