FDA Medical Device Recalls (openFDA)
Greiner Bio-One North America, Inc.: Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.
- Recall number
- Z-0184-2012
- Recalling firm
- Greiner Bio-One North America, Inc.
- Product
- Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.
- Status
- Terminated
- Initiated
- 2011-08-12
- Posted
- 2011-11-14
- Terminated
- 2012-03-12
- Reason
- Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.
- Root cause
- Process control
- Action
- Consignees were notified by Greiner bio-one letter on August 11, 2011. They were instructed to: Stop distributing the material, complete the product Disposition form attach and to fax it to Greiner bio-one and to destroy or return any of the affected products for replacement or credit. Distributors were asked to provide a list of their customers that have received the item, preferably in an Excel file, so that they could be notified of the recall.
- Quantity
- 504,000 pieces
- Distribution
- Nationwide.
- Lot, serial or model codes
- Item #454209, Lot #B051111.
- 510(k) numbers
- ["K971236"]
- 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