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U.S. Department of Health and Human Services

Class 3 Device Recall BD Microtainer Tube

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  Class 3 Device Recall BD Microtainer Tube see related information
Date Initiated by Firm May 17, 2007
Date Posted June 21, 2007
Recall Status1 Terminated 3 on August 15, 2007
Recall Number Z-0957-2007
Recall Event ID 37953
510(K)Number K002456  
Product BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ
Code Information Catalog Number 365992 Lot numbers: 6139630, 6213209, 6296815 and 7059245
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact David M. Pieratos
Manufacturer Reason
for Recall
Mislabeling : box and bag labels are incorrectly labeled to indicate the product contains Sodium Fluoride/Potassium Oxalate, however the instructions for use and the product itself are correct in the additive indicated and used (Sodium Fluoride/Na2EDTA).
FDA Determined
Cause 2
Action Product Recall letters dated May 1, 2007. were sent to all distributors by first class mail. The letter requested all distributors to examine inventory for specific catalog and lot numbers. It also requested distributors to send a copy of the enclosed customer letter to all customers as a subrecall. BD has contracted a third party (West Inc., Appleton, Wisconsin) to coordinate the mailing to all customers, if the firm chooses to use the third party, or the distributor can send the letters themselves.
Quantity in Commerce 142,800 worldwide
Distribution Worldwide; USA, Canada, Australia, Chile, Columbia, Japan, Malaysia, New Zealand, Singapore, Bangladesh and Indonesia

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 = and Original Applicant = BECTON DICKINSON VACUTAINER SYSTEMS