Class 2 Device Recall Becton Dickinson

• Date Initiated by Firm: December 20, 2016
• Create Date: October 11, 2018
• Recall Status: Terminated on April 20, 2018
• Recall Number: Z-1440-2017
• Recall Event ID: 76129
• 510(K)Number: K161170
• Product Classification: Needle, hypodermic, single lumen - Product Code FMI
• Product: Eclipse Hypodermic Needle
• Code Information: N/A
• FEI Number: 2243072
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Ms. Zuleika Sanchez; 201-847-5216
• Manufacturer Reason for Recall: BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries.
• FDA Determined Cause: Device Design
• Action: BD sent a Product Advisory Notice and Business Reply Card dated December 29, 2016 via UPS Ground delivery to their affected customers.
• Quantity in Commerce: 263 mm units
• Distribution: US Nationwide
• 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 = FMI