FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: Microtainer Brand Tube with EDTA (K2), Catalog Number 365974.
- Recall number
- Z-0447-03
- Recalling firm
- Becton Dickinson & Company
- Product
- Microtainer Brand Tube with EDTA (K2), Catalog Number 365974.
- Status
- Terminated
- Initiated
- 2002-10-16
- Posted
- 2003-01-16
- Terminated
- 2004-04-15
- Reason
- Insufficient amount of EDTA found within the tube causing clotting and erroneous platelet counts.
- Root cause
- Other
- Action
- Becton Dickinson contacted their Distributors and customers with return instructions via certified mail on or about Oct. 16, 2002.
- Quantity
- 141600
- Distribution
- The firm distributed this product nationwide to wholesalers and direct customers.
- Lot, serial or model codes
- Lot #2098765
- 510(k) numbers
- ["K940905"]
- 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