FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
- Recall number
- Z-1210-2019
- Recalling firm
- Becton Dickinson & Company
- Product
- SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
- Status
- Terminated
- Initiated
- 2019-02-28
- Posted
- 2019-06-26
- Terminated
- 2020-07-30
- 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.
- 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: customerfeedback@bd.com
- Quantity
- 2900 Sets
- Distribution
- US Nationwide Distribution in the states of AR, NH, NC
- Lot, serial or model codes
- Lot Number: 18046218 Exp. Date: 04/18/2021 UDI: 50885403234352
- 510(k) numbers
- ["K811885"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28