Class 2 Device Recall BD QSyte Luer Access Split Septum

• Date Initiated by Firm: February 19, 2015
• Date Posted: March 25, 2015
• Recall Status: Terminated on May 25, 2017
• Recall Number: Z-1317-2015
• Recall Event ID: 70593
• 510(K)Number: K013621
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
• Code Information: Lot #'s 4128925 and 4128926
• 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: Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
• FDA Determined Cause: Process control
• Action: Becton Dickinson sent an Urgent Voluntary Product Recall Letter/Recall Response Card/Packing Instructions, dated 2/19/15, to their affected customers via UPS next day mail. The letters identified the affected device and explained the reason for the recall. Customers were to review their inventory for the specific catalog and lot numbers provided and quarantine the affected product. The Recall Response Card form should be completed and faxed back to BD at 1-866-514-2113 or e-mail bd7043@stericycle.com. All affected product should be returned with the completed Recall Response Card following the steps on the enclosed packing instruction. Upon receipt of the returned product, BD will send customers replacement product. If customers have questions or require assistance, they should contact 1-866-800-2917.
• Quantity in Commerce: 315,800 units
• Distribution: Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.
• 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