FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.
- Recall number
- Z-1923-2013
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.
- Status
- Terminated
- Initiated
- 2013-05-01
- Posted
- 2013-08-07
- Terminated
- 2015-12-04
- Reason
- BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.
- Root cause
- Under Investigation by firm
- Action
- BD sent a Product Advisory Notice dated May 3, 2013, via UPS to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discard filled tubes since it is possible they will contain less blood volume (low draws), replace the Luer Adaptor unit being used with a fresh unit, and continue to draw blood samples using the fresh unit. Customers with questions were instructed to contact BD Technical Service at 1-800-631-0174, Option 4, or contact them through website: www.bd.com/vacutainer/contact. For questions regarding this recall call 201-847-6800.
- Quantity
- 37,906,400 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Marketing Status: Class II, 510K # K991088 Device Listing Number: D030347 Catalog number 367290, 367300 (CE), 368491, and 303380.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JKA
- 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