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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-2747-2017
Recall Event ID 77513
510(K)NumberK110771 
Product Classification Syringe, piston - Product Code FMF
ProductBD 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/
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 Commerce22,400 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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