FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Direct Draw Adapters, Catalog Number 364896.
- Recall number
- Z-1463-06
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Direct Draw Adapters, Catalog Number 364896.
- Status
- Terminated
- Initiated
- 2006-06-21
- Posted
- 2006-09-09
- Terminated
- 2007-06-07
- Reason
- 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.
- Root cause
- Other
- Action
- BD sent out recall notifications on 6/21/2006 to distributors and their direct account customers.
- Quantity
- 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;
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KSR
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28