FDA Medical Device Recalls (openFDA)
Greiner VACUETTE North America: Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile.
- Recall number
- Z-1331-04
- Recalling firm
- Greiner VACUETTE North America
- Product
- Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile.
- Status
- Terminated
- Initiated
- 2004-07-27
- Posted
- 2004-08-10
- Terminated
- 2004-10-29
- Reason
- Coagulation tubes may not have received the proper fill of citrate solution.
- Root cause
- Other
- Action
- Consignees were notified by letter on 7/28/2004.
- Quantity
- 314 cases (376,800 pieces)
- Distribution
- Nationwide
- Lot, serial or model codes
- Item no. 454332, Lot number B040404
- 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