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U.S. Department of Health and Human Services

Class 2 Device Recall Becton Dickinson

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  Class 2 Device Recall Becton Dickinson see related information
Date Initiated by Firm December 20, 2016
Create Date October 11, 2018
Recall Status1 Terminated 3 on April 20, 2018
Recall Number Z-1440-2017
Recall Event ID 76129
510(K)Number K161170  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product Eclipse Hypodermic Needle
Code Information N/A
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Ms. Zuleika Sanchez
201-847-5216
Manufacturer Reason
for Recall		 BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries.
FDA Determined
Cause 2		 Device Design
Action BD sent a Product Advisory Notice and Business Reply Card dated December 29, 2016 via UPS Ground delivery to their affected customers.
Quantity in Commerce 263 mm units
Distribution US Nationwide
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 = FMI and Original Applicant = Becton, Dickinson and Company
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