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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 Recall
BD Vacutainer Plastic Plasma Separator Tube (PST) Plus
see related information
Date Posted March 06, 2013
Recall Status1 Open
Recall Number Z-0911-2013
Recall Event ID 64013
Premarket Notification
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/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes, New Jersey 07417-1815
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. Gregary W. Morgan
201-847-6800
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JKA and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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