Recall Z-1081-2012 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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.
| Date | Feb 22, 2012 (initiated Dec 14, 2011) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960857 | GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR Greiner America, Inc., Aug 30, 1996 |