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/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
|
For Additional Information Contact |
201-847-6800
|
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
|