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U.S. Department of Health and Human Services

Class 3 Device Recall BD Microtainer MAP Microtube for Automated Process.

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  Class 3 Device Recall BD Microtainer MAP Microtube for Automated Process. see related information
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
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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