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U.S. Department of Health and Human Services

Class 2 Device Recall BD

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 Class 2 Device Recall BDsee related information
Date Initiated by FirmApril 30, 2009
Date PostedJune 24, 2009
Recall Status1 Terminated 3 on September 28, 2009
Recall NumberZ-1488-2009
Recall Event ID 52023
Product Classification syringe - Product Code FMF
ProductBD 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.
FEI Number 2243072
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactGreg Morgan
201-847-4344
Manufacturer Reason
for Recall		Potential for compromised sterility: Insufficient packaging seals.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionBecton 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 Commerce201,600 units
DistributionNationwide Distribution.
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.
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