Recall Z-0719-2011 ยท EXS Urinometer, Electrical
C.R. Bard, Inc., Urological Division
Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter
| Date | Dec 21, 2010 (initiated Nov 17, 2010) |
| Status | Terminated |
| Reason | Error can occur in the reading of the Present Interval Output (PIO) reading when the device is subjected to bumping or forceful replacement of the fluid container. |
| Root cause | Other |
| Action | Consignees were notified by an Urgent: Product Advisory Letter and Medica Device Recall letter on/about November 18, 2010. The letter identified the affected product, stated the reason for recall, the interim precautions, and actions to be taken. The letter requested acknowledgement of the recall and to return the entire affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. Affected product received by Bard Medical will be reworked with the software upgrade and place back into distr |
| Quantity | 234 units |
| Distribution | Worldwide Distribution -- U.S., Netherlands, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.