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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 Traysee related information
Date Initiated by FirmMay 01, 2013
Date PostedJune 21, 2013
Recall Status1 Terminated 3 on September 25, 2013
Recall NumberZ-1577-2013
Recall Event ID 65243
510(K)NumberK992734 
Product Classification Syringe, antistick - Product Code MEG
ProductBD 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 ContactMs. 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
ActionDirect 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 Commerce1,326,000 units
DistributionWorldwide Distribution including US Nationwide and the countries of Canada and Suriname.
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 = MEG
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