Class 3 Device Recall Becton Dickinson BD Vacutainer SST Plus Blood Collection Tubes

• Date Initiated by Firm: June 23, 2015
• Date Posted: August 20, 2015
• Recall Status: Terminated on April 06, 2016
• Recall Number: Z-2434-2015
• Recall Event ID: 71633
• 510(K)Number: BK050036
• Product Classification: Tubes, vials, systems, serum separators, blood collection - Product Code JKA
• Product: BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
• Code Information: REF #367986, Lot #'s 5133957 and 5133959
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Ms. Yogindra Dellow; 201-847-5033
• Manufacturer Reason for Recall: Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time.
• FDA Determined Cause: Process control
• Action: Becton Dickinson notified their affected customers of this recall by sending them an Urgent Product Recall Letter dated June 23, 2015 via UPS 2nd Day.
• Quantity in Commerce: 238, 000 (Lot #5133959) and 243,000 (Lot #5133957)
• Distribution: Distributed in FL, IL, MA, MI, MO, PA and TN.
• 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.