Z-1463-06

BD Direct Draw Adapters, Catalog Number 364896

Name: Z-1463-06 BD Direct Draw Adapters, Catalog Number 364896
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 Direct Draw Adapters, Catalog Number 364896 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-1463-06
Status: Terminated
Initiated: 2006-06-21
Posted: 2006-09-09
Terminated: 2007-06-07
Recalling firm: Becton Dickinson & Co
Product: BD Direct Draw Adapters, Catalog Number 364896.
Product code: KSR Container, Empty, For Collection & Processing Of Blood & Blood Components
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: 234,450 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 Number 364896, Lot Numbers 5311376, 5312193, 5312201.--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 KSR

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)