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U.S. Department of Health and Human Services

Class 2 Device Recall BD

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 Class 2 Recall
BD
see related information
Date Posted June 24, 2009
Recall Status1 Terminated on September 28, 2009
Recall Number Z-1488-2009
Recall Event ID 52023
Product Classification Syringe, Piston - 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, New Jersey 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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