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U.S. Department of Health and Human Services

Class 2 Device Recall Becton Dickinson Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes

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  Class 2 Device Recall Becton Dickinson Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes see related information
Date Initiated by Firm November 12, 2012
Create Date June 26, 2015
Recall Status1 Terminated 3 on September 06, 2013
Recall Number Z-0756-2013
Recall Event ID 64010
510(K)Number K013971  
Product Classification Tubes, vials, systems, serum separators, blood - Product Code JKA
Product BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
Code Information Lot No. 2180434; Expiration Date: April 2013
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Yogindra Dellow
201-847-5033
Manufacturer Reason
for Recall		 BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints.
FDA Determined
Cause 2		 Material/Component Contamination
Action BD sent "ATTENTION: PRODUCT RECALL" letters dated November 12, 2012 via UPS to distributors and customers instructing them to examine their inventory immediately and discontinue the shipment of the affected product. All customers were instructed to return all products from the lot affected, by following the instructions on the enclosed packing slip,and BD will send them replacement products at no charge. Contact the firm at 10201-847-4267 for assistance.
Quantity in Commerce 2,944,700 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands.
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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