Date Initiated by Firm |
April 30, 2009 |
Date Posted |
June 24, 2009 |
Recall Status1 |
Terminated 3 on September 28, 2009 |
Recall Number |
Z-1488-2009 |
Recall Event ID |
52023 |
Product Classification |
syringe - Product Code FMF
|
Product |
BD 20 ml Syringe Luer-Lok Tip Sterile, Do not reuse; Catalog Number 309661.
|
Code Information |
Catalog Number 309661: Lot numbers: 9065361, 9065362, 9065366, 9065367, 9065380. |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
|
For Additional Information Contact |
Greg Morgan 201-847-4344
|
Manufacturer Reason for Recall |
Potential for compromised sterility: Insufficient packaging seals.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Becton Dickinson sent Urgent Product Recall letters on April 30, 2009 to all direct customers. Questions are to be directed to BD Customer Service at 1-888-237-2762.
Letters to customers of distributors went out on May 12, 2009. |
Quantity in Commerce |
201,600 units |
Distribution |
Nationwide Distribution. |
Total Product Life Cycle |
TPLC Device Report
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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.
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