LH Lithium Heparin tubes, Greiner bio-one, North America… recallZ-1081-2012 · Greiner Bio-One North America, Inc. · initiated Dec 14, 2011
Terminated All recalls posted in February 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Greiner Bio-One North America, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The lithium heparin tubes may have a contamination with EDTA potassium.
FDA root cause category: Material/Component Contamination
What the company is doing
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.
Recall details
- Recall number
- Z-1081-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 14, 2011
- Posted by the FDA
- Feb 22, 2012
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 2,082,000 pieces
- Product code
- JKA
- FDA submissions
- K960857
- Distribution
- Nationwide Distribution.
Product description
LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
3 devices cleared under K960857 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Vacuette 456087PGreiner Bio-One GmbH · Tubes, vials, systems, serum separators, blood collection1 recall0 reports
- Vacuette 454008PGreiner Bio-One GmbH · Tubes, vials, systems, serum separators, blood collection1 report
- Vacuette 456287PGreiner Bio-One GmbH · Tubes, vials, systems, serum separators, blood collection1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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