Recall Z-0657-2007 ยท DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405.
| Date | Mar 27, 2007 (initiated Jan 12, 2007) |
| Status | Terminated |
| Reason | The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.) |
| Root cause | Other |
| Action | Consignees were notified by phone between 1/12/07 and 2/23/07 and informed replacement hand cranks would be shipped. |
| Quantity | 22 |
| Distribution | Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900815 | SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL 3M Company, May 9, 1990 |