CLASS II Device recall · Reported 16 Mar 2016 · FDA Enforcement Report

BD Intelliport Medication Management System Sensor recalled

Becton Dickinson & is recalling BD Intelliport Medication Management System Sensor The system is indicated for use by, distributed in California, Utah. The recall was initiated on 9 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog (Ref) # 516700 Lot numbers 5222723, 5251583 and 5253723.

Quantity recalled250 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1076-2016
FDA event ID: 73008
Recalling firm: Becton Dickinson &, Franklin Lakes, NJ
Classification: Class II
Status: Terminated
Recall initiated: 9 Dec 2015
FDA classified: 8 Mar 2016
Reported: 16 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

9 Dec 2015	Recall initiated by company
8 Mar 2016	Classified by FDA	+90 days
16 Mar 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The sterility of the product cannot be assured. This may result in increased risk of infection.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

US Distribution to:California and Utah.

California Utah

Questions about this recall

Is BD Intelliport Medication Management System Sensor The system is indicated for use by recalled?

Yes. Becton Dickinson & recalled BD Intelliport Medication Management System Sensor The system is indicated for use by on 9 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-1076-2016.

Why was it recalled?

The sterility of the product cannot be assured. This may result in increased risk of infection.

Which lots are affected?

Catalog (Ref) # 516700 Lot numbers 5222723, 5251583 and 5253723.

Where was it sold?

US Distribution to:California and Utah.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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