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
|