Medical device recalls High risk

Becton Dickinson & Company recalls SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696

Recall date
February 28, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1210-2019
FDA classification
Class I
Brand / firm
Becton Dickinson & Company
Sold / distributed
US Nationwide Distribution in the states of AR, NH, NC

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696

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