Z-1462-06

BD Vacutainer Luer Adapter; Catalog #367290 and #367300

Name: Z-1462-06 BD Vacutainer Luer Adapter; Catalog #367290 and #367300
Creator: Becton Dickinson & Company
Published: 2006-06-21
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2006-06-21 / Terminated

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Luer Adapter; Catalog #367290 and #367300 on 2006-06-21. The reason FDA records is "Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1462-06
Status: Terminated
Initiated: 2006-06-21
Posted: 2006-09-09
Terminated: 2007-06-07
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Luer Adapter; Catalog #367290 and #367300.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.
FDA root cause: Other
Action: BD sent out recall notifications on 6/21/2006 to distributors and their direct account customers.
Quantity in commerce: 3,324,000 units
Distribution: World wide-Products are distributed nationwide to distributors and direct accounts. The products are also distributed internationally to the following locations: Japan, Australia, Canada, Hong Kong, New Zealand. For European distribution, the products are shipped to Temse located in Belgium who handles the recall. Temse has been identified as recalling only the following products and lots: Catalog Number 364896 (Direct Draw Adapter), lots 5311376, 5312193, 5312201. Catalog Number 367300 (Luer Adapter), lots 5307894, 5307896, 5307900. Government accounts include the VAMC in Erie, PA;
Product codes and lots: Catalog No: 367290 Lot Number 5305585; Catalog No: 367300 Lot Numbers 5307894; 5307896; 5307900. For European distribution, the products are shipped to Temse located in Belgium who handles the recall. Temse has been identified as recalling only the following products and lots: Catalog Number 364896 (Direct Draw Adapter), lots 5311376, 5312193, 5312201. Catalog Number 367300 (Luer Adapter), lots 5307894, 5307896, 5307900.

Product code JKA

K991088Class IIVacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood ColleBecton Dickinson Vacutainer Systems / cleared 1999-05-28

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)