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Recall

Class I — Becton Dickinson & Company

Recalling firmBecton Dickinson and Company
Registered facilityView this company's 36 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass I
StatusTerminated
ReasonLeaking 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.
ProductSmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Quantity2900 Sets
DistributionUS Nationwide Distribution in the states of AR, NH, NC
Initiated2019-02-28
Classified2019-06-26
Terminated2020-07-30
Recall numberZ-1210-2019
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class I recall — Becton Dickinson & Company (Z-1210-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82273/

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