Z-3028-2011

BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305...

Name: Z-3028-2011 BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305...
Creator: Becton Dickinson & Company
Published: 2011-04-22
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2011-04-22 / Terminated / root cause: design

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm); BD Vacutainer Push Button Blood Collection Set... on 2011-04-22. The reason FDA records is "BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3028-2011
Status: Terminated
Initiated: 2011-04-22
Posted: 2011-08-16
Terminated: 2012-06-06
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm); BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x 3/4 x 12" 0.8 x 19 mm x 305 mm Blood collection system.
Product code: KST System, Blood Collection, Vacuum-Assisted, Manual
Reason for recall: BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub.
Root cause tag: design
FDA root cause: Device Design
Action: BD Diagnostics sent a "Lot Specific Product Recall" letter dated April 22, 2011 to all affected customers. The letter asked customers return any affected product and provides instructions for its return. The letter ask customers return the attached Packaging List with the shipment. For question on this recall contact BD Diagnostics at (201) 847-5117.
Quantity in commerce: 1,744,000
Distribution: Nationwide (USA) Distribution.
Product codes and lots: Catalog # 367324, Lot #0315173, 0316102, 0323342, 0327441, and 1025938; Catalog # 367326, Lot #0309244, 0309286, and 0312571; Catalog #367344, Lot #0334101, 0336557, 0347425, 0354635, and 10131090.

Product code KST

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)