FDA Medical Device Recalls (openFDA)
Greiner Bio-One North America, Inc.: LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes.
- Recall number
- Z-1081-2012
- Recalling firm
- Greiner Bio-One North America, Inc.
- Product
- LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes.
- Status
- Terminated
- Initiated
- 2011-12-14
- Posted
- 2012-02-22
- Terminated
- 2012-06-21
- Reason
- The lithium heparin tubes may have a contamination with EDTA potassium.
- Root cause
- Material/Component Contamination
- Action
- Greiner Bio-One sent a "RECALL OF LITHIUM HEPARIN TUBES WITH EDTA CONTAMINATION" letter dated December 13, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete an attached Product Disposition Site Confirmation Form and to fax the form to 800-726-0052. This form will confirm that customers have discarded/destroyed all affected product. The firm will replace the product after receipt of the form. Contact the firm at 800-515-8112 for questions regarding this recall.
- Quantity
- 2,082,000 pieces
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Item #456087, Lot #B07115 and B08116, Item #454244, #B091112, Item #456087CA, Lot #B091106, Item #456287, Lot #B101114, Item #454237, Lot #B091108 and Item #456287, Lot #B091110.
- 510(k) numbers
- ["K960857"]
- 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