Recall Z-1498-06 ยท GIM Tubes, Vacuum Sample, With Anticoagulant
Greiner Bio-One North America, Inc.
Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Sterile * manufactured by: Greiner Bio-one North America, Inc., 4238 Capital Drive, Monroe, NC 28110, USA
| Date | Sep 13, 2006 (initiated Aug 2, 2006) |
| Status | Terminated |
| Reason | Coagulation tubes found with no additive. |
| Root cause | Other |
| Action | Consignees were notified by letter via fax starting 08/02/2006. |
| Quantity | 160 cases (192000 pieces) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971221 | GREINER VACUETTE BLOOD COLLECTION TUBE Greiner America, Inc., May 2, 1997 |