Class 2 Device Recall 3mL LuerLok Syringe

• Date Initiated by Firm: February 01, 2019
• Create Date: July 22, 2019
• Recall Status: Terminated on June 11, 2020
• Recall Number: Z-2007-2019
• Recall Event ID: 82138
• 510(K)Number: K980987
• Product Classification: Syringe, piston - Product Code FMF
• Product: 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
• Code Information: Lot Number 8303571
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• Manufacturer Reason for Recall: The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Medical Device Recall notification letters dated 2/1/19 were sent to customers.
• Quantity in Commerce: 460,800
• Distribution: The products were distributed to the following US states: FL, IL, KS, MA, ND, NH, NY, OH, PA, RI, SC, VA, and WI. The products were distributed to the following foreign countries: Suriname.
• 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 and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC