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.
FDA Recall Z-1076-2016 · Posted 2016-03-08
Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodePHC
Date Initiated2015-12-09
Date Terminated2017-01-09
Product Quantity250 units
Reason for Recall
The sterility of the product cannot be assured. This may result in increased risk of infection.
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 [email protected] even if you do not have any of the affected lot; and return all affected products with the completed Recall Response Form following instructions on the enclosed packing instruction.
If customers have any questions or require assistance with the return of the recalled product and/or availability of replacement product, they were instructed to contact 1-201-847-4267 between 8AM and 5 PM ET Monday through Friday.
Root Cause
Under Investigation by firm
Distribution Pattern
US Distribution to:California and Utah.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.