Z-1210-2019Class I

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

Name: Z-1210-2019 SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Creator: Becton Dickinson & Company
Published: 2019-02-28
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-02-28 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696 on 2019-02-28. FDA classified it as Class I and 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1210-2019
Classification: Class I
Status: Terminated
Initiated: 2019-02-28
Posted: 2019-06-26
Terminated: 2020-07-30
Recalling firm: Becton Dickinson & Co
Product: SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Product code: FPA Set, Administration, Intravascular
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: BD distributors provided a hard copy of the recall letter on February 28, 2019 via FedEx and may also be contacted via e-mail (when available). Distributors are requested to identify their customers and provide BD a customer list so that BD can undertake further communication to the users. BD will distribute the recall communication to the distributor customers via FedEx upon receiving the customer information from the distributors. A copy of the BD product recall customer letter was provided to distributors, in the case they opt to contact their customers directly. BD is requesting that customers destroy product at their location. Distributors will be asked to return product. A Customer Response Form to be completed and returned. Questions: Phone: 888-812-3266 Phone hours: 24 hours a day, 7 days a week Email: [email protected]
Quantity in commerce: 2900 Sets
Distribution: US Nationwide Distribution in the states of AR, NH, NC
Product codes and lots: Lot Number: 18046218 Exp. Date: 04/18/2021 UDI: 50885403234352

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1210-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1210-2019	Class I	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-26

Product code FPA

K811885Class II30-30-2 700 Syringe Extension SetY / cleared 1981-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)