BD SmartSite recallZ-1210-2019 · Becton Dickinson & Company · initiated Feb 28, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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]
Recall details
- Recall number
- Z-1210-2019
- Status
- Terminated
- Initiated by the company
- Feb 28, 2019
- Posted by the FDA
- Jun 26, 2019
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 2900 Sets
- Product code
- FPA
- FDA submissions
- K811885
- Distribution
- US Nationwide Distribution in the states of AR, NH, NC
Product description
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Code information (models, lots, serial numbers)
Lot Number: 18046218 Exp. Date: 04/18/2021 UDI: 50885403234352
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD SmartSite 10798696BD Switzerland Sàrl · Set, administration, intravascular1 recall32 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page