FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
- Recall number
- Z-2304-2019
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
- Status
- Terminated
- Initiated
- 2019-06-12
- Posted
- not on file
- Terminated
- 2020-06-29
- Reason
- False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
- Root cause
- Device Design
- Action
- Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers.
- Quantity
- 1,436,228,004 total
- Distribution
- Worldwide Distribution, including US Nationwide
- Lot, serial or model codes
- UDI: (01)30382903679639
- 510(k) numbers
- ["K945952"]
- 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