Date Initiated by Firm |
April 09, 2007 |
Date Posted |
May 24, 2007 |
Recall Status1 |
Terminated 3 on August 09, 2007 |
Recall Number |
Z-0813-2007 |
Recall Event ID |
37871 |
510(K)Number |
K980987
|
Product Classification |
syringe - Product Code FMF
|
Product |
BD 5ml Syringe Luer-Lok Tip Bulk Sterile Convenience Pak Latex Free |
Code Information |
Lot number 7002604 Ref 309703 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
|
For Additional Information Contact |
Greg Morgan 210-847-4344
|
Manufacturer Reason for Recall |
Small cracks in plastic trays of one lot of BD 5mL Syringe Luer Lok Tip, Bulk Sterile Convenience Paks that may adversely affect tray integrity and steriity.
|
FDA Determined Cause 2 |
Other |
Action |
Recall communications were sent on April 2, 2007 and May 3, 2007 by UPS second day air to all direct consignees and potential customers. |
Quantity in Commerce |
174,300 units |
Distribution |
Nationwide. |
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 = FMF and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
|