LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection
FDA device recall Z-1081-2012 · posted 2012-02-22 · Terminated
Recall details
- Recalling firm
- Greiner Bio-One North America, Inc.
- Reason for recall
- The lithium heparin tubes may have a contamination with EDTA potassium.
- Action taken
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 2,082,000 pieces
- Distribution
- Nationwide Distribution.
- Date initiated
- 2011-12-14
- Date posted
- 2012-02-22
- Date terminated
- 2012-06-21
- Location
- Monroe, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR (K960857) | Greiner America, Inc. | 1996-08-30 |