Class 2 Device Recall BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (Catalog Reference 366560)

• Date Initiated by Firm: April 11, 2018
• Create Date: June 20, 2018
• Recall Status: Terminated on May 10, 2019
• Recall Number: Z-2260-2018
• Recall Event ID: 79901
• 510(K)Number: K013971
• Product Classification: Tubes, vials, systems, serum separators, blood collection - Product Code JKA
• Product: The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.
• Code Information: All lots
• 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: Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
• FDA Determined Cause: Nonconforming Material/Component
• Action: BD began notifying distributors on April 11, 2018. Customer communications were mailed on April 12-13th, 2018. US customers will be sent a letter via UPS beginning April 12, 2018. Distributors were e-mailed on April 11, 2018 and requested that they provide a list of their consignees to facilitate mailing to end users BD Regions will be contacted via email regarding distribution outside of the US Distributors were instructed to return customer lists to BD. Letters will be mailed with UPS tracking, which provides for a 100% effectiveness check. Customer response form will be tabulated. 100% of non-responders will be contacted by phone.
• Distribution: US/PR-All 50 states and PR Global-AR, BO, BR, BS, BZ, CA, CO, CR, CW, DO, EC, GT, GY, IN, JM, JP, KR, MX, NI, PA, PE, SG, SR, SV, TT, TW, UY, VI Dates of distribution: June 2, 2017 to the present.
• 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 = JKA