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U.S. Department of Health and Human Services

Class 2 Device Recall BD SafetyGlide Allergy Syringe Tray

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  Class 2 Device Recall BD SafetyGlide Allergy Syringe Tray see related information
Date Initiated by Firm May 01, 2013
Date Posted June 21, 2013
Recall Status1 Terminated 3 on September 25, 2013
Recall Number Z-1577-2013
Recall Event ID 65243
510(K)Number K992734  
Product Classification Syringe, antistick - Product Code MEG
Product BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.
Code Information Catalog/Lot Number: REF#305950 Lot 2132028 and Lot 2159189
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Ms. Yogindra Dellow
201-847-6800
Manufacturer Reason
for Recall		 There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.
FDA Determined
Cause 2		 Process control
Action Direct consignees were contacted by phone and email on 05/01/2013 and instructed to return the affected product. End users were mailed "Urgent: Product Recall" letters/Response Forms dated 05/01/2013. The notice advises customers of the product issue, identifies affected product and provides instructions on how to handle affected product.
Quantity in Commerce 1,326,000 units
Distribution Worldwide Distribution including US Nationwide and the countries of Canada and Suriname.
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 = MEG and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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