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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Becton Dickinson & Company
- 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
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