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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 Recall
BD Vacutainer Push Button collection Set
see related information
Date Posted December 27, 2010
Recall Status1 Terminated on June 06, 2012
Recall Number Z-0816-2011
Recall Event ID 56972
Premarket Notification
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/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes, New Jersey 07417-1815
For Additional Information Contact Ms. Yogindra Dellow
201-547-5033
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
PRODUCTION CONTROLS: 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 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.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = BECTON DICKINSON & CO.
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