Z-1076-2016Class II

BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare...

Name: Z-1076-2016 BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare...
Creator: Becton Dickinson & Company
Published: 2015-12-09
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2015-12-09 / Terminated / root cause: sterility

FDA source

Becton Dickinson & Company began a recall of BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare professionals in a hospital or medical center setting with... on 2015-12-09. FDA classified it as Class II and gives the reason as "The sterility of the product cannot be assured. This may result in increased risk of infection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1076-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-09
Posted: 2016-03-08
Terminated: 2017-01-09
Recalling firm: Becton Dickinson & Co
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.
Product code: PHC Infusion Safety Management Software
Reason for recall: The sterility of the product cannot be assured. This may result in increased risk of infection.
Root cause tag: sterility
FDA 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 [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.
Quantity in commerce: 250 units
Distribution: US Distribution to:California and Utah.
Product codes and lots: Catalog (Ref) # 516700 Lot numbers 5222723, 5251583 and 5253723.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1076-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1076-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08

Product code PHC

K141474Class IIBecton Dickinson Intelliport SystemBecton, Dickinson & CO / cleared 2014-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)