Recall Z-1076-2016 ยท PHC Infusion Safety Management Software
Becton Dickinson & Company
BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.
| Date | Mar 8, 2016 (initiated Dec 9, 2015) |
| Status | Terminated |
| Reason | The sterility of the product cannot be assured. This may result in increased risk of infection. |
| Root cause | Under Investigation by firm |
| Action | Becton Dickinson representatives notified their customers in person and a copy of the "Urgent Product Recall" letter and "Recall Response Form" dated 12/9/2015 was provided. The letter identified the reason for the recall; how to identify affected product; and the actions to be taken. The letter instructed customers to immediately review their inventory; complete the enclosed Recall Response Form and fax (1-201-847-4267 it to BD or email it to Becky_Saggau@bd.com even if you do not have any of the affected lot; and return all affected products with the completed Recall Response Form following |
| Quantity | 250 units |
| Distribution | US Distribution to:California and Utah. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141474 | BECTON DICKINSON INTELLIPORT SYSTEM Becton, Dickinson & CO, Dec 18, 2014 |