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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 Setsee related information
Date Initiated by FirmFebruary 28, 2019
Date PostedJune 26, 2019
Recall Status1 Terminated 3 on July 30, 2020
Recall NumberZ-1210-2019
Recall Event ID 82273
510(K)NumberK811885 
Product Classification Set, administration, intravascular - Product Code FPA
ProductSmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Code Information Lot Number: 18046218 Exp. Date: 04/18/2021 UDI: 50885403234352
FEI Number 2243072
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
ActionBD 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 Commerce2900 Sets
DistributionUS Nationwide Distribution in the states of AR, NH, NC
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FPA
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