Date Initiated by Firm |
February 11, 2011 |
Date Posted |
November 08, 2011 |
Recall Status1 |
Terminated 3 on November 10, 2011 |
Recall Number |
Z-0176-2012 |
Recall Event ID |
59684 |
510(K)Number |
K093972
|
Product Classification |
Tubes, vials, systems, serum separators, blood collection - Product Code JKA
|
Product |
BD Microtainer MAP Microtube for Automated Process with K2EDTA.
For the collection, transport, and automated processing of skin punctures samples from infants, children, geriatric, oncology, and critical care patients. |
Code Information |
Lot # 1018904 Catalog # 363706 |
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 Microtainer MAP Microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of EDTA additive.
|
FDA Determined Cause 2 |
Device Design |
Action |
A Becton Dickinson Sales Consultant conducted a "on-site" visit to the single Customer account, Florida Hospital, on February 11, 2011.
All units were successfully recovered. All product recovered was quarantined and destroyed. Becton Dickinson believes that all reasonable efforts to communicate the issue to the affected consignee have been completed.
If you have any questions or request additional information please do not hesitate to call (201) 847-5636. |
Quantity in Commerce |
10,800 units |
Distribution |
Distributed only to Florida. |
Total Product Life Cycle |
TPLC Device Report
|
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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.
|
510(K) Database |
510(K)s with Product Code = JKA and Original Applicant = BECTON DICKINSON & CO.
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