Recall Z-0184-2012 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Greiner Bio-One North America, Inc.
Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.
| Date | Nov 14, 2011 (initiated Aug 12, 2011) |
| Status | Terminated |
| Reason | Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills. |
| Root cause | Process control |
| Action | Consignees were notified by Greiner bio-one letter on August 11, 2011. They were instructed to: Stop distributing the material, complete the product Disposition form attach and to fax it to Greiner bio-one and to destroy or return any of the affected products for replacement or credit. Distributors were asked to provide a list of their customers that have received the item, preferably in an Excel file, so that they could be notified of the recall. |
| Quantity | 504,000 pieces |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971236 | GREINER VACUETTE BLOOD COLLECTION TUBE Greiner America, Inc., May 12, 1997 |