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U.S. Department of Health and Human Services

Class 3 Device Recall BD Vacutainer Plastic Plasma Separator Tube (PST) Plus

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  Class 3 Device Recall BD Vacutainer Plastic Plasma Separator Tube (PST) Plus see related information
Date Initiated by Firm March 05, 2012
Date Posting Updated March 06, 2013
Recall Status1 Terminated 3 on July 20, 2015
Recall Number Z-0911-2013
Recall Event ID 64013
510(K)Number K945952  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA.

Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing.

Code Information Reference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Ms. Yogindra Dellow
Manufacturer Reason
for Recall
BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints.
FDA Determined
Cause 2
Equipment maintenance
Action BD sent advisory letters via UPS dated 3/5/2012 to customers. The letter identified the affected product and the reason for recall. BD has taken steps to modify the existing manufacturing and assembly processes to help reduce the potential for this condition. Questions regarding this issue should be directed to BD Global Technical Services at 1-800-631-0174 or email at www.bd.com/Vascutainer/contact.
Quantity in Commerce 225 million units
Distribution Nationwide Distribution
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