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U.S. Department of Health and Human Services

Class 2 Device Recall Intelliport Medication Management System

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  Class 2 Device Recall Intelliport Medication Management System see related information
Date Initiated by Firm December 09, 2015
Date Posted March 08, 2016
Recall Status1 Terminated 3 on January 09, 2017
Recall Number Z-1076-2016
Recall Event ID 73008
510(K)Number K141474  
Product Classification Infusion safety management software - Product Code PHC
Product 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.
Code Information Catalog (Ref) # 516700 Lot numbers 5222723, 5251583 and 5253723.
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Ms. Zuleika S¿nchez
Manufacturer Reason
for Recall
The sterility of the product cannot be assured. This may result in increased risk of infection.
FDA Determined
Cause 2
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 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.
Quantity in Commerce 250 units
Distribution US Distribution to:California and Utah.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PHC and Original Applicant = BECTON DICKINSON & CO.