Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1210-2019 · Posted 2019-06-26

Recall StatusTerminated
Product CodeFPA
Date Initiated2019-02-28
Date Terminated2020-07-30
Product Quantity2900 Sets

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.

Firm 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]

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑