FDA Medical Device Recalls (openFDA)
Greiner Bio-One North America, Inc.: Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Sterile * manufactured by: Greiner Bio-one North America, Inc., 4238 Capital Drive, Monroe, NC 28110, USA
- Recall number
- Z-1498-06
- Recalling firm
- Greiner Bio-One North America, Inc.
- Product
- Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Sterile * manufactured by: Greiner Bio-one North America, Inc., 4238 Capital Drive, Monroe, NC 28110, USA
- Status
- Terminated
- Initiated
- 2006-08-02
- Posted
- 2006-09-13
- Terminated
- 2007-01-11
- Reason
- Coagulation tubes found with no additive.
- Root cause
- Other
- Action
- Consignees were notified by letter via fax starting 08/02/2006.
- Quantity
- 160 cases (192000 pieces)
- Distribution
- Nationwide
- Lot, serial or model codes
- Item #454332, Lot #B050609
- 510(k) numbers
- ["K971221"]
- PMA numbers
- not on file
- Product code
- GIM
- 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