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U.S. Department of Health and Human Services

Class 1 Device Recall SmartSite Syringe Administration Set

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  Class 1 Device Recall SmartSite Syringe Administration Set see related information
Date Initiated by Firm February 28, 2019
Date Posted June 26, 2019
Recall Status1 Terminated 3 on July 30, 2020
Recall Number Z-1210-2019
Recall Event ID 82273
510(K)Number K811885  
Product Classification Set, administration, intravascular - Product Code FPA
Product SmartSite Syringe Administration Set-Product Package Size 50,
Catalog Number: 10798696
Code Information Lot Number: 18046218 Exp. Date: 04/18/2021 UDI: 50885403234352
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 2900 Sets
Distribution US Nationwide Distribution in the states of AR, NH, NC
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = Y