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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Push Button Blood Collection Set

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  Class 2 Device Recall BD Vacutainer Push Button Blood Collection Set see related information
Date Initiated by Firm April 22, 2011
Date Posted August 16, 2011
Recall Status1 Terminated 3 on June 06, 2012
Recall Number Z-3028-2011
Recall Event ID 59218
Product Classification Hematology Blood Collection System, Vacuum-Assisted, Manual - Product Code KST
Product BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm);
BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x 3/4 x 12" 0.8 x 19 mm x 305 mm

Blood collection system.
Code Information Catalog # 367324, Lot #0315173, 0316102, 0323342, 0327441, and 1025938;  Catalog # 367326, Lot #0309244, 0309286, and 0312571;   Catalog #367344, Lot #0334101, 0336557, 0347425, 0354635, and 10131090.
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Mr. Richard Vales
201-847-5117
Manufacturer Reason
for Recall		 BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub.
FDA Determined
Cause 2		 Device Design
Action BD Diagnostics sent a "Lot Specific Product Recall" letter dated April 22, 2011 to all affected customers. The letter asked customers return any affected product and provides instructions for its return. The letter ask customers return the attached Packaging List with the shipment. For question on this recall contact BD Diagnostics at (201) 847-5117.
Quantity in Commerce 1,744,000
Distribution Nationwide (USA) Distribution.
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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