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U.S. Department of Health and Human Services

Class 2 Device Recall BD 10 ml Syringe Luer Lok Tip

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  Class 2 Device Recall BD 10 ml Syringe Luer Lok Tip see related information
Date Initiated by Firm January 07, 2008
Date Posted April 16, 2008
Recall Status1 Terminated 3 on May 19, 2008
Recall Number Z-0915-2008
Recall Event ID 46347
Product Classification Piston syringe - Product Code FMF
Product BD 10 ml Syringe Luer Lok Tip, Reorder #3039605, BD, Franklin Lakes, NJ 07417.
Code Information Reorder number: 3039605; Lot numbers 7061015, 7061014, 7092726, 7094789, 7094790, 7123223, 7123225, 7150947, 7150949, 7184442, 7184443, 7184446, 7212935, 7239568, 7239570, 7239569, 7271873.
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		 Defective Seal: The convenience trays may have open seals, which can adversely impact tray sterility.
FDA Determined
Cause 2		 Packaging
Action BD notified distributors by an Urgent Product Recall Letter sent via UPS on January 7, 2008. In addition, the firm sent an Urgent Product Recall Letter on January 11, 2008 to customers identified by the distributors. The letter instructed the users to remove the product from its inventory and to return affected products to the firm using an enclosed customer packing list. For additional information, contact 1-888-237-2762.
Quantity in Commerce 2,926,560
Distribution Nationwide, including the states of CA, NY, MO, MA, IL, OH, TN, TX, MI, LA, MO, ID, GA, NE, SC and FL.
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.
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