Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates."

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
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Infusion Sets
Hazard: leaking
contamination
exposure
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:

Same manufacturer · Becton Dickinson & Company

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