The Recall Desk
HighFDA (Devices)·Z-1076-2016·Announced 2016-03-16

BD Intelliport Medication Management System Sensor Recalled for Sterility Concerns

Becton Dickinson is recalling 250 units of the BD Intelliport Medication Management System Sensor because the sterility of the product cannot be assured, posing an increased risk of infection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (infection risk due to sterility issues) where no specific injuries or illnesses have been reported in the source text, aligning with the High severity criteria for theoretical or unreported harm.

Plain-English summary

Becton Dickinson & Company is recalling 250 units of the BD Intelliport Medication Management System Sensor. The recall is due to concerns that the sterility of the product cannot be assured, which may result in an increased risk of infection.

The affected units are identified by Catalog (Ref) # 516700 and Lot numbers 5222723, 5251583, and 5253723. These products were distributed in the United States to California and Utah.

The system is indicated for use by healthcare professionals in a hospital or medical center setting to facilitate documentation of manually administered bolus intravenous injections. Healthcare professionals should stop using the affected units and contact Becton Dickinson for further instructions.

The recalled product

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 documen
Affected units
250

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed in 2 states: