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

FDA Recall #Z-1076-2016 — Class II — December 9, 2015

Recall #Z-1076-2016 Date: December 9, 2015 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

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

Recalling Firm

Becton Dickinson & Company — Franklin Lakes, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

250 units

Distribution

US Distribution to:California and Utah.

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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