| Class 3 Device Recall BD Microtainer Tube | |
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/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
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For Additional Information Contact | David M. Pieratos 201-847-4548 |
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 | Other |
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 |
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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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510(K) Database | 510(K)s with Product Code =
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