Class 2 Device Recall BD Vacutainer SST Plus Tubes

• Date Initiated by Firm: February 13, 2018
• Date Posted: June 01, 2018
• Recall Status: Terminated on March 09, 2020
• Recall Number: Z-2055-2018
• Recall Event ID: 79709
• 510(K)Number: K023075
• Product Classification: Tubes, vials, systems, serum separators, blood collection - Product Code JKA
• Product: BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
• Code Information: 1) UDI DI (01)50382903679831 PI (17)180531(10)7135828(30)1000 Lot/Serial # 7315828 Exp Date 5/31/2018 2) UDI DI (01)50382903679831 PI (17)180531(10)7146901(30)1000 Lot/Serial # 7125692 Exp Date 4/30/2018
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: BD Preanalytical Systems ; 877-870-4486
• Manufacturer Reason for Recall: Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
• FDA Determined Cause: Nonconforming Material/Component
• Action: On March 15, 2018 BD Life Sciences sent Urgent Medical Device Recall Notifications to affected customers. Customers were instructed to : 1. Immediately review your inventory for the subject lots and quarantine the product subject to the recall. 2. Share this recall notification with all users of the product to ensure they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. Return all affected products using the enclosed packaging instructions and include the completed Recall Response Form with the product. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. Web: Medwatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088); Mail: MedWatch, HF-2, FDA 5600 Fisher's Lane, Rockville, MD 20853-9787. Customer who require further assistance should contact BD Preanalytical Systems at (877)870-4486, Mon-Fri 8:00am-5:00pm
• Quantity in Commerce: 9,568,900 total products
• Distribution: US Nationwide, Argentina, Belize , Brazil, Canada, China, Guam, India, Japan, Mexico, Nicaragua, Pakistan, Philippines, Singapore, Suriname, Taiwan
• 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