FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Vacutainer Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x x 12 Catalog 367344
- Recall number
- Z-1532-2018
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Vacutainer Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x x 12 Catalog 367344
- Status
- Terminated
- Initiated
- 2018-03-20
- Posted
- not on file
- Terminated
- 2020-04-20
- Reason
- Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
- 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
- Quantity
- not on file
- Distribution
- US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania
- Lot, serial or model codes
- 7346627 7348974 7348975 7354740 7354743 7354745 7354764 8005556 8005557 8005814 8010735 8012910 8015923 8015925
- 510(k) numbers
- ["K030573"]
- 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