Z-1532-2018Class II

BD Vacutainer Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x x 12 Catalog 367344

Name: Z-1532-2018 BD Vacutainer Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x x 12 Catalog 367344
Creator: Becton Dickinson & Company
Published: 2018-03-20
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-03-20 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x x 12 Catalog 367344 on 2018-03-20. FDA classified it as Class II and gives the reason as "Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6". 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-1532-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-20
Posted: 2018-04-26
Terminated: 2020-04-20
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x x 12 Catalog 367344
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Immediately review your inventory for the specific Catalog (Ref) and lot numbers, and quarantine product subject to the recall. Immediately discontinue the distribution of the affected product. If you have inventory of the recalled product, please complete the attached Business Response Form and return the recalled product following the enclosed packing instruction. This is required so that BD may process your product replacement. If you do not have the recalled product, please complete the attached Business Response Form as well so that BD receives an acknowledgement of your receipt of this recall notification
Distribution: US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania
Product codes and lots: 7346627 7348974 7348975 7354740 7354743 7354745 7354764 8005556 8005557 8005814 8010735 8012910 8015923 8015925

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1532-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1531-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-26
Z-1532-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-26
Z-1533-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-26

Product code JKA

K030573Class IIBd Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341Bd Vacutainer Systems Preanalyical Solutions / cleared 2003-05-08

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)