Z-2434-2015Class III

BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting...

Name: Z-2434-2015 BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting...
Creator: Becton Dickinson & Company
Published: 2015-06-23
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2015-06-23 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in... on 2015-06-23. FDA classified it as Class III and gives the reason as "Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time". 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-2434-2015
Classification: Class III
Status: Terminated
Initiated: 2015-06-23
Posted: 2015-08-20
Terminated: 2016-04-06
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Becton Dickinson notified their affected customers of this recall by sending them an Urgent Product Recall Letter dated June 23, 2015 via UPS 2nd Day.
Quantity in commerce: 238, 000 (Lot #5133959) and 243,000 (Lot #5133957)
Distribution: Distributed in FL, IL, MA, MI, MO, PA and TN.
Product codes and lots: REF #367986, Lot #'s 5133957 and 5133959

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2434-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2434-2015	Class III	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20

Product code JKA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)