Date Initiated by Firm |
September 16, 2016 |
Create Date |
July 19, 2017 |
Recall Status1 |
Terminated 3 on March 20, 2018 |
Recall Number |
Z-2752-2017 |
Recall Event ID |
77513 |
510(K)Number |
K110771
|
Product Classification |
Syringe, piston - Product Code FMF
|
Product |
BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection |
Code Information |
6061746 2021-02 6082982 2021-02 6089821 2021-03 6117858 2021-04 6117863 2021-04 6117889 2021-04 6117891 2021-04 6146962 2021-04 6173697 2021-05 6173767 2021-06 6173779 2021-06 6208614 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 2 |
Process control |
Action |
BD sent recall letter/return response form on 9/16/2016. |
Quantity in Commerce |
547,600 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
|