The Recall Desk
HighFDA (Devices)·Z-1210-2019·Announced 2019-07-03

Becton Dickinson Recalls SmartSite Syringe Administration Sets Due to Leaking

Becton Dickinson is recalling SmartSite Syringe Administration Sets because they may leak, potentially interrupting infusions or exposing healthcare workers to fluids.

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 (medical device) where injury has not yet been reported, fitting the High severity criteria for potential contamination and exposure.

Plain-English summary

Becton Dickinson & Company is recalling 2,900 sets of SmartSite Syringe Administration Sets (Catalog Number: 10798696, Lot Number: 18046218, Exp. Date: 04/18/2021). The recall is due to a defect where the sets may leak.

The leaking may result in a delay or interruption of infusion, under-infusion, contamination of the fluid path, and exposure of healthcare professionals to infusates. The affected products were distributed nationwide in the states of Arkansas, New Hampshire, and North Carolina.

Healthcare facilities should stop using the affected lots and contact Becton Dickinson for further instructions. Consumers are not expected to have these products in their homes, as they are medical devices intended for professional use.

The recalled product

Product
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Affected units
2,900

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 (1)

  • Lot Number: 18046218 Exp. Date: 04/18/2021 UDI: 50885403234352

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically: