Recall Z-1331-04 ยท GIM Tubes, Vacuum Sample, With Anticoagulant
Greiner VACUETTE North America
Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile.
| Date | Aug 10, 2004 (initiated Jul 27, 2004) |
| Status | Terminated |
| Reason | Coagulation tubes may not have received the proper fill of citrate solution. |
| Root cause | Other |
| Action | Consignees were notified by letter on 7/28/2004. |
| Quantity | 314 cases (376,800 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 |