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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 Recall
BD SafetyGlide Allergy Syringe Tray
see related information
Date Posted June 21, 2013
Recall Status1 Terminated on September 25, 2013
Recall Number Z-1577-2013
Recall Event ID 65243
Premarket Notification
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, New Jersey 07417-1815
Consumer Instructions Contact the recalling firm for information
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.
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 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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