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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer(R) Brand Plus PST Separation Tubes

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  Class 2 Device Recall BD Vacutainer(R) Brand Plus PST Separation Tubes see related information
Date Initiated by Firm January 16, 2017
Create Date February 10, 2017
Recall Status1 Terminated 3 on February 07, 2018
Recall Number Z-1189-2017
Recall Event ID 76295
510(K)Number K945952  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm)
Catalog Number: 369714

Product Usage:
The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations
Code Information Lot 6090572
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Mr. Matthew Kelleher
201-847-6800
Manufacturer Reason
for Recall		 A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.
FDA Determined
Cause 2		 Process control
Action BD sent an Urgent Product Recall letter dated January 16, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Customer Recall Response Form and fax the completed form back to BD at 1-844-388-5534 or email the completed form to bd8872@stericycle.com. For questions call 1-844-265-7408.
Quantity in Commerce 1,488,800 tubes
Distribution Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia
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 = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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