Recall Z-0617-2007 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Terumo Cardiovascular Systems Corp
Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.
| Date | Mar 14, 2007 (initiated Dec 12, 2006) |
| Status | Terminated |
| Reason | Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached. |
| Root cause | Other |
| Action | Consignees will be notified via letter dated 12/12/06, which provides instructions for identifying defective manual drives and to contact the firm if their unit is defective. |
| Quantity | 2696 |
| Distribution | Woldwide, including USA, Canada, and Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882758 | CENTRIFUGAL PUMP SYSTEM LX/DX VERSION 3M Health Care, Sarns, Oct 13, 1988 |