Recall Z-0069-06 ยท KRA Catheter, Continuous Flush
Becton Dickinson Medical Systems
DTX(tm) Plus DT-DL60 Continuous flush catheter
| Date | Oct 21, 2005 (initiated Jul 1, 2005) |
| Status | Terminated |
| Reason | Device could permit an over-infusion of IV solutions during pressure monitoring procedures. |
| Root cause | Other |
| Action | Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST. |
| Quantity | 6725 units |
| Distribution | Nationwide, including PR. VA facilities in OH, WA, NV and NY. No military or foreign distribution by US firm.. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K791844 | CRITIFLO & CRITIFLO DOME Gould, Inc., Oct 2, 1979 |