Recall Z-0822-06 ยท CAC Apparatus, Autotransfusion
Haemonetics Corporation
Haemonetics Cell Saver 5 Autogolous Blood Recovery System Model Numbr: LN02005-110-E
| Date | Apr 29, 2006 (initiated Dec 21, 2005) |
| Status | Terminated |
| Reason | Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard |
| Root cause | Other |
| Action | Haemonetics notified accounts by Certified Letter on 12/21/05. A field correction will be schedule to replace the LCD . |
| Quantity | 3 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014083 | HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM Haemonetics Corp., Jan 8, 2002 |