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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Push Button collection Set

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  Class 2 Device Recall BD Vacutainer Push Button collection Set see related information
Date Initiated by Firm October 05, 2010
Date Posted December 27, 2010
Recall Status1 Terminated 3 on June 06, 2012
Recall Number Z-0816-2011
Recall Event ID 56972
510(K)Number K011984  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product BD Vacutainer Push Button collection Set;
Non-Pyrogenic, Sterile, Rx only;
23 G x 3/4 x 12" (0.6 x 19 mm x 305 mm)
Becton Dickinson & Co., Franklin Lakes, NJ, USA

Intended use: Blood collection
Code Information Catalog Number 367342; Lot numbers: 0145457, 0152300, 0153981, 0153982, 0158081, 0158082, 0158084, 0160664, 0160666, all exp 5/31/2012; Lot numbers 0165202, 0165205, 0165207, 0165218, 0165226, 0165227, 0165232, 0165234, 0176872, 0179208, 0179209, 0179212, 0180023, 0180026, 0180027, 0180028, 0180040, 0180042, all exp 6/30/2012; Lot numbers 0196209, 0196210, 0201399, 0201400, 0201402, 0208593, 0211641, all exp 7/31/2012. 
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Ms. Yogindra Dellow
Manufacturer Reason
for Recall
There is the possibility for certain lots of the BD Vacutainer Push Button Blood Collection sets to have separation of the cannula from the hub.
FDA Determined
Cause 2
Process control
Action BD Diagnostics sent "RECALL NOTIFICATION" separate letters October 1 and 5, 2010 and follow up letter dated October 8, 2010, as well as a letter dated December 1, 2010 to all distributors and customers commencing October 5, 2010 by federal express. The letters describe the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory for specific catalog and lot numbers, and return product from the lots following the instructions on the enclosed packing slip (BD will send replacement upon receipt of returned product). If you have any questions on returning and replacing product, please contact BD logistics at 1-866-380-0046. If you have any further detail questions regarding this recall, please contact your BD Sales Consultant or BD Technical Services via email at www.BD.com/Vacutainer/Contact or via telephone at 1-800-631-0174.
Quantity in Commerce 4,223,200
Distribution Nationwide 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.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = BECTON DICKINSON & CO.