Class I recall: Becton Dickinson & Company’s SmartSite Syringe Administration Set

July 2, 2019

The Food and Drug Administration has announced that Becton Dickinson & Company’s SmartSite Syringe Administration Set recall is identified as a Class I recall, the most serious type of recall as the devices may cause serious injuries or death.

BD is recalling its SmartSite Syringe Administration Sets due to leaking of the sets which may result in under‐infusion of critical medications, delay or interruption of infusions, contamination of the fluid paths and/or healthcare provider exposures to hazardous medications.

The BD SmartSite Syringe Administration Sets are used with an infusion pump to deliver fluids including medications, blood and blood products into a patient’s body in a controlled manner. The pump administers fluid into a patient’s vein or other cleared routes of administration via an infusion tubing set. The infusion sets are intended to be used with the BD Alaris or Medley Syringe Pumps, Module 8110. The devices are used in hospitals and other health care facilities. This product is primarily used to provide critical therapies to patients in the Neonatal Intensive Care Unit (NICU).

Delayed infusion or under-infusion of life-sustaining medications could result in serious adverse health consequences, particularly for very low birth-weight babies (micro-preemies). Additionally, contamination of the fluid path could result in an increased risk of infection for patients.

To date, BD has not received any reports of serious injury or death due to the malfunction of this device.

Recalled product details:

·  Becton Dickinson (BD) SmartSite Syringe Administration Set

·  Model/Catalog Number: 10798696

·  Serial/Lot Numbers: 18046218

·  Manufacturing Dates: April 18, 2018

·  Distribution Dates: May 11, 2018 to September 14, 2018

·  Devices Recalled in the U.S.: 2,900

·  Date Initiated by Firm: February 22, 2019