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Recall Observatory FDA recall evidence

Device product

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

Z-1210-2019

February 28, 2019

Class I

Product summary

Firm
Becton Dickinson & Company
Event
Event 82273
Status
Terminated
Classification
Class I
Quantity
2900 Sets
Official record key
device-enforcement:Z-1210-2019

Official wording

Reason: 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.

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

Distribution pattern: US Nationwide Distribution in the states of AR, NH, NC

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.