Z-0911-2013Class III

BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF...

Name: Z-0911-2013 BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF...
Creator: Becton Dickinson & Company
Published: 2012-03-05
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-03-05 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of 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... on 2012-03-05. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0911-2013
Classification: Class III
Status: Terminated
Initiated: 2012-03-05
Posted: 2013-03-06
Terminated: 2015-07-20
Recalling firm: Becton Dickinson & Co
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.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Reference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0911-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0911-2013	Class III	Terminated	Voluntary: Firm initiated	2013-03-13	2013-03-06

Product code JKA

K945952Class IIVacutainer(r) Brand Plus Pst(tm) Plasma Separation TubeBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1995-01-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)