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U.S. Department of Health and Human Services

Class 2 Device Recall Needle Trap/ Needle Safety Label

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  Class 2 Device Recall Needle Trap/ Needle Safety Label 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-2748-2017
Recall Event ID 77513
510(K)Number K951254  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product BD SafetyGlide" Injection Needle
Catalog #305917
The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination
Code Information 6022838 2021-01
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 29,500 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 = FMI and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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