FDA Medical Device Recalls (openFDA)
Greiner VACUETTE North America: Serum Blood Collection Tubes
- Recall number
- Z-0086-06
- Recalling firm
- Greiner VACUETTE North America
- Product
- Serum Blood Collection Tubes
- Status
- Terminated
- Initiated
- 2005-07-28
- Posted
- 2005-10-22
- Terminated
- 2005-11-16
- Reason
- Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution.
- Root cause
- Other
- Action
- Consignees were notified by letter on 07/28/2005.
- Quantity
- 1623 cases (1,947,600 pieces)
- Distribution
- Nationwide, Chile, Costa Rica, Ecuador, El Salvador, Nicaragua and Uruguay.
- Lot, serial or model codes
- Item #455071, Lot #B040513 and Item #455092, Lot #B040503
- 510(k) numbers
- ["K960858"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 3001451379
- Firm city
- Monroe
- Firm state
- NC
- 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