—#171256

Product

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

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K811885
Affected lot / code info: Lot Number: 18046218 Exp. Date: 04/18/2021 UDI: 50885403234352

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.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: US Nationwide Distribution in the states of AR, NH, NC

Timeline

Recall initiated: 2019-02-28
Posted by FDA: 2019-06-26
Terminated: 2020-07-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171256. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.