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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 Syringesee related information
Date Initiated by FirmSeptember 16, 2016
Create DateJuly 19, 2017
Recall Status1 Terminated 3 on March 20, 2018
Recall NumberZ-2752-2017
Recall Event ID 77513
510(K)NumberK110771 
Product Classification Syringe, piston - Product Code FMF
ProductBD 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
ActionBD sent recall letter/return response form on 9/16/2016.
Quantity in Commerce547,600 units
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FMF
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