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U.S. Department of Health and Human Services

Class 2 Device Recall BD Single Use, Hypodermic Syringe

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  Class 2 Device Recall BD Single Use, Hypodermic Syringe see related information
Date Initiated by Firm September 16, 2016
Create Date July 19, 2017
Recall Status1 Terminated 3 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/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
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 2
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 and Original Applicant = Becton, Dickinson and Company