SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
FDA Recall Z-1210-2019 · Posted 2019-06-26
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Recalling FirmBecton Dickinson & Company
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.
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