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U.S. Department of Health and Human Services

Class 2 Device Recall 3mL LuerLok Syringe

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  Class 2 Device Recall 3mL LuerLok Syringe see related information
Date Initiated by Firm February 01, 2019
Create Date July 22, 2019
Recall Status1 Terminated 3 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/
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 2
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