SmartSite Syringe Administration Set-Product Package Size 50 — Class I medical device recall Z-1210-2019
Terminated recall by Becton Dickinson & Company, reported 2019-07-03, distributed nationwide. Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-in
| Recall number | Z-1210-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2019-02-28 |
| Classified | 2019-06-26 |
| Reported by FDA | 2019-07-03 |
| Terminated | 2020-07-30 |
| Distributed | Nationwide (US) |
| Quantity | 2,900 sets |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 50885403234352 |
| Lot numbers | 18046218 |
| Model numbers | 10798696 |
| Expiration dates | 2021-04-18 |
Product
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1210-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.