Recall Z-0388-04 ยท FPA Set, Administration, Intravascular
Greiner VACUETTE North America
Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria.
| Date | Jan 29, 2004 (initiated Dec 16, 2003) |
| Status | Terminated |
| Reason | Product may have a defective connection. |
| Root cause | Other |
| Action | Distributors and end users were notified by certified mail or fax on 12/16/2003. |
| Quantity | 5 cases (5000 pieces) |
| Distribution | The product was shipped to medical facilities in IN, NY and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992145 | ECOMED SCALP VEIN SET Greiner Meditech, Inc., Oct 14, 1999 |