Recall Z-0500-03 ยท CAC Apparatus, Autotransfusion
Haemonetics Corporation
Haemonetics Basic Low Volume (125ml) Cell Saver 5 Bowl Set List Number: 261
| Date | Jan 30, 2003 (initiated Dec 17, 2002) |
| Status | Terminated |
| Reason | Disposable Set for Autologous Blood recovery may leak saline at the Y-connector |
| Root cause | Other |
| Action | Haemonetics notified accounts of the recall on December 17, 2002 by fax. A hard copy of the same letter was sent to each customer via certified mail, return receipt on December 18 and 19. Users are requested to cease use of product and return product to Haemonetics. |
| Quantity | 4138 |
| Distribution | Nationwide Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932890 | CELL SAVER 5 SYSTEM Haemonetics Corp., Jan 5, 1994 |