Class 2 Device Recall BD Single Use, Hypodermic Syringe

• Date Initiated by Firm: September 16, 2016
• Create Date: July 19, 2017
• Recall Status: Terminated on March 20, 2018
• Recall Number: Z-2747-2017
• Recall Event ID: 77513
• 510(K)Number: K110771
• Product Classification: Syringe, piston - Product Code FMF
• Product: BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
• Code Information: 6204878 2021-07
• 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: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
• FDA Determined Cause: Process control
• Action: BD sent recall letter/return response form on 9/16/2016.
• Quantity in Commerce: 22,400 units
• Distribution: Nationwide Distribution
• 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 = FMF